Events

Thursday, 1 November 2018:
QP Forum in association with PHSS

Cost: PQG members £250 + vat (£300) Non-members £300 + vat (£360)

 

Venue: Baskerville Hall Hotel, Clyro Court

Location: Hay-on-Wye, Powys  HR3 5LE Click here for location and directions

Meeting begins: 09:30 ends 16:30

BOOKINGS

Bookings will be via the  PHSS  website.  If you are a PQG member please email Sarah at admin@pqg.org. I will send you a code and a link (within 48 hours) which will allow you to book at the discounted rate of £250 + VAT.

The PHSS QP Forum was established in 2011 by a group of Welsh QPs who wanted a local network and a local forum. What was missing locally was the ability to network, keep up to date and complete relevant CPD. This Forum has expanded to a small annual conference open to all. Each year a conference is held on the first Thursday in November.

The scope is wide and covers new medicinal products, new technology, new regulations, guidance and standards. We have a mixture of speakers from the pharmaceutical industry, suppliers to the industry and academia. The annual conference is geared to practical advice, review of new and current regulatory guidance and industry/research/hospital speakers talking through their own processes. Hopefully it covers some areas of required CPD. We generate a conference environment favourable to frank and confidential discussions on Quality Systems and QA/QP responsibilities.The delegates are from manufacturing, research and development, service industries and hospital delegates and we aim to be a wide based Pharmaceutical compliance forum.

Agenda:

Start time Course Content Speaker
09:30 Registration
10:00 Welcome Kay O’Hagan Quality Consultant/QP – Tecmac UK Ltd
10:15 Investigating Sterility Test failures Tim Sandle Head of MicroBiology – Bio Products Laboratory Ltd
11:15 Coffee
11:30 Brexit and the QP Sam Clack Quality Consultant/QP – Quaph Consulting Limited
12:30 Serialisation – be ready for February 2019 Kevin Lival Process Engineering Specialist – Norgine
13:30 Lunch
14:15 Annex 1 update – what has changed? Di Morris
15:15 ISO 14644 – parts 3 and 4 update Tim Triggs GM of UK Operations and Director of EMEA region – Air Techniques International
16:15 Close Kay O’Hagan

 

 


Wednesday, 13 June 2018:
Trainee QP, Sponsors & QP CPD Day

Date: Wednesday 13th June 2018

Location: Fletchers Hall 3 Cloth St, London EC1A 7LD Farmers’ & Fletchers’ Hall Location 1 minute from Barbican tube station 5 minutes from St.Paul’s tube station.

Meeting begins: 09:00, ending at 17:00

This seminar is aimed at QPs, trainee QPs and their sponsors.The day will include a Legislative update from NSF’s Pete Gough to enable participants to keep up to date with the changing world of pharmaceuticals.  Alex Hall of QPQuandary and RSSL will be providing an overview of what the assessors are looking for and tips to help you pass the VIVA.

 

09:00 Registration and coffee
09:25 Introduction Damian Larrington (PQG and Pfizer)
09:30 What should you do to prepare for your VIVA? – Damian Larrington (PQG and Pfizer)
09:45 Submitting for the VIVA and what is the VIVA like on the day – Kina Vyas (QP officer for the Royal Pharmaceutical Society)
10:20 What does the QP assessor want to see and hear? Alex Hall (QPQuandary)
11:00 Coffee/tea break
11:15 Regulatory update – Pete Gough (Executive Director – NSF)
12:45 Lunch
13:30 Viva practice – Pete Gough, Stephan Croft and Damian Larrington
15:30 Coffee/tea break
15:45 QP Scenarios – Real life examples to help prepare for your VIVA
16:45 Closing comments – Damian Larrington
17:00 Close

The meeting will also provide an ideal forum for discussion, an excellent opportunity to network with other QPs and will count towards your CPD.

The cost of the meeting includes a hot lunch (with vegetarian options) and tea/coffee at breaks.

To book your place and pay by Credit Card, click on the green button at the top of this advert.

Confirmation of your place and VAT receipt: You will receive this by e-mail within a week of booking your place. A certificate of attendance will be provided at the meeting for your CPD records.

To contact the meeting organiser: e-mail admin@pqg.org

 


Tuesday, 24 April 2018:
Making Pharmaceuticals Free 2 Day Event

2 Day Event 24th & 25th April 2018, Ricoh Arena, Coventry.

PQG speakers are presenting at Making Pharmaceuticals which, according to the publicity material “is the only dedicated FREE TO ATTEND event in the UK that addresses the detailed and complex issues associated with sourcing, manufacturing, outsourcing and delivering consistent pharmaceutical products to the market”. There are 70+ seminars and workshops covering a wide range of topics, and 100+ exhibitors.

PQG speakers will be presenting on the 25th April in Room A

09:15 – 09:45  Understanding and Control of the Supply Chain – Are We There Yet?  (Steve Moss, Pharmaceutical Quality Group)

09:45 – 10:15  PQG/ ECA’s GDP guide – Latest Developments (Kane Edgeworth, Biomap)

For more details please see the event website: https://www.makingpharma.com/

All bookings and enquiries must be made via the meeting organiser.


Thursday, 19 April 2018:
Good Distribution Practice (GDP): Meeting the challenges

Date: Thursday 19th April 2018

Venue: Pullman Hotel, 100 – 110 Euston Road, London,NW1 2AJ Click here for location and directions to the Pullman Hotel

Meeting begins: This meeting will begin at 9:30 and end by 16:00.

Directions from Kings Cross St Pancras  follow the British Library exit signs, turn right onto Euston Road. Walk for 300m past the British Library, the hotel is located 5m on the right.

Directions from  Euston Station turn left on Euston Road at the Fire station and follow Euston Road for 600m. The hotel is on your left after Chalton Street.

Good Distribution Practice is essential to ensuring that the quality of medicines is maintained all the way through the supply chain.This event will help you to meet the challenges of complying with GDP with a team of highly experienced Responsible Persons and input from MHRA.

Each participant will be able to attend two of three workshops focussed on topics where regulatory inspections findings are most commonly made.  These workshops will be led by Ciaran Brady (PLS Pharma), Ashley McCraight (Ashley McCraight Associates) and Sue Mann (Sue Mann Consultancy) with Afshin Hosseiny (Tabriz Consulting and Chair of European GDP Association).

All attendees will also be provided with a copy of the new GDP monograph developed jointly by PQG and the European Compliance Academy.

The proposed agenda is given below (this may be subject to change)

9:30 Chairman’s Introduction (Ashley McCraight)
09:40 GDP Interpretation document – history, development, final version & thank you!  (Phil Butson)
10:00 MHRA Presentation (Tony Orme)
10:45 Q&A
11:00 Coffee/tea break
11:30 Workshops (1 – QMS, 2 – Transportation, 3 – RP – roles & responsibilities)
12:30 Lunch
13:30 Workshops (1 – QMS, 2 – Transportation, 3 – RP – roles & responsibilities)
14:30  Coffee/tea break
14:45 How to achieve compliance without interrupting business activities (Afshin Hosseiny)
15:30 Panel Discussion with Team leaders & MHRA
16:00  Final words from chairman & End of the course

To book your place and pay by Credit Card, click on the green button above in this advert.

To contact the meeting organiser: e-mail admin@pqg.org

Confirmation of your place and VAT receipt: You will receive this by e-mail within a week of booking your place. A certificate of attendance will be provided at the meeting for your CPD records.


Tuesday, 20 March 2018:
The PQG Annual General Meeting (PQG Members only)

The PQG Annual General Meeting (PQG Members only)

Date: Tuesday 20th March 2018

Venue: NEW VENUE Pullman Hotel, 100 – 110 Euston Road, London,NW1 2AJ Click here for location and directions to the Pullman Hotel

Meeting begins: This meeting will begin at approx 9:30 and end by 10:45.

Directions from Kings Cross St Pancras  follow the British Library exit signs, turn right onto Euston Road. Walk for 300m past the British Library, the hotel is located 5m on the right.

Directions from  Euston Station turn left on Euston Road at the Fire station and follow Euston Road for 600m. The hotel is on your left after Chalton Street.

PQG members do not need to book for this part of the meeting.


Tuesday, 20 March 2018:
The 21st Annual Discussion Meeting with the MHRA for QPs, QA Managers and their colleagues (open to Non Members)

BOOKINGS HAS NOW CLOSED

Date: Tuesday 20th March 2018

Location: NEW VENUE Pullman Hotel, 100-110 Euston Road, London, NW1 2AJ Click here for location and directions to the Pullman Hotel

Meeting begins: This meeting will begin at approx 11:00 and end by 16:30.

Speakers:

Alastair Jeffrey – Head of the Enforcement Group

Alastair joined the MHRA in July 2013 and is responsible for leading the Enforcement Group, ensuring an appropriate and proportionate response to allegations of unlawful activity within the UK in relation to medicines and medical devices. Alastair is a member of the Permanent Forum on International Pharmaceutical Crime; Interpol’s Operation Pangea management committee and is the Euro Vice-Chair of the WHO Member State Mechanism meeting on Substandard and Falsified Medicines. Prior to joining the MHRA, Alastair spent over 30 years in the Metropolitan Police Service. The last 12 years were spent at New Scotland Yard, where he was a senior investigating officer on the Homicide Command and went on to lead the Child Abuse Investigation Command, Surveillance Command and the Covert Policing Command as a Detective Chief Superintendent. Alastair has a Masters Degree in Applied Criminology from Cambridge University.

Jan MacDonald – Group Manager, Access and Information for Medicines and Standards
Jan is a pharmacist by profession and has a master’s degree from King’s College London.   She has worked in the public sector throughout her career and currently heads up the Patient Information Quality Unit where she is responsible for the MHRA policy on medicines labelling and packaging.
What the Group does: The Access and Information for Medicines and Standards (AIMS) Group consists of 4 units – Advertising Standards and Outreach Unit, Product Information Quality Unit, Self-Medication Unit and E-Cigarette Unit. The AIMS Group has been designed to lead thinking on wider access to medicines; to champion excellent patient information, in the UK and in Europe; to deliver communications on medicines to healthcare professionals and the public, and to promote high standards in medicines advertising.

Questions:

We would like to invite questions on the following topics:

  • Serialisation
  • Falsified Medicines
  • Management of importation  / exportation of packs in/out EU with regard to Serialisation
  • Web based sales – e-commerce of prescription and OTC products
  • Responsibilities of the MAH versus the MIAH

Please submit questions to admin@pqg.org asap to allow sufficient time for MHRA to review and collate responses.

To book your place and pay by Credit Card, click on the green button above in this advert.

Early booking is advised: As this is a very popular meeting, early booking is advisable.

To facilitate participation and open discussion, numbers will be strictly limited to 50 attendees.

To contact the meeting organiser: e-mail admin@pqg.org

Confirmation of your place and VAT receipt: You will receive this by e-mail within a week of booking your place. A certificate of attendance will be provided at the meeting for your CPD records.


Monday, 12 March 2018:
EU GMP ANNEX 1 DRAFT REVISION INSIGHT Joint PHSS & PQG Conference – Discussion

Venue: Woodland Grange, Leamington Spa

Location: Old Milverton Lane, Leamington Spa CV32 6RN

Meeting begins: 10:00 am ending at 16:30

Cost: PQG members £250 + vat (£300) Non-members £350 + vat (£420)

BOOKINGS

Bookings will be via the PHSS website.  If you are a PQG member please email Sarah at admin@pqg.org. I will send you a code and a link (within 24 hours) which will allow you to book at the discounted rate of £250 + VAT.

Following the revision of EU GMP Annex 1 for Sterile Medicinal product manufacturing the PHSS: Pharmaceutical & Healthcare Society and PQG: Pharmaceutical Quality Group are joining together to host a discussion on the revision with the regulatory authorities.

The revision of Annex 1 will impact all in sterile medicinal product manufacturing and those sectors where Annex 1 applies: Advanced therapies and Hospital pharmacy aseptic services.

Comments from both PHSS and the PQG Annex 1 focus groups will be collated and submitted to the EMA.

The MHRA are invited to join the discussion with the PHSS & PQG on the impact of the Annex 1 revision and discuss focus group comments that are in preparation for submission to the EMA.

The Conference will also host exhibitors that have technologies and services that support sterile and therapeutic product manufacturing and aseptic processing.

Limited places available, both PHSS and PQG members can book at the discounted price of £250 + VAT.

AGENDA

Key note presentation: Regulatory perspective on EU GMP Annex 1 consultation document.

10.00am – 11.00am: Andrew Hopkins MHRA GDMP Expert: Head of EU GMP Annex 1 EMA/PICS/WHO revision working group.

Presentation: Pharma industry perspective on EU GMP Annex 1 consultation document.

11.00am – 12.00pm: Ian Symonds GSK Head, Aseptic Strategy and Intelligence, Pharma Ops, Global Function representing the PHSS & PQG Annex 1 Focus group preparing comments from the Pharma Industry on the revised Annex 1 draft/ consultation document.

12.15pm – 12.45pm: Overview-listing of PHSS-PQG Comments to be submitted to the EMA presented by discussion facilitators covering each of the Annex 1 chapters providing an insight to the type and extent of PHSS-PQG comments.

12.45pm – 2.00pm: Lunch break / viewing exhibition / networking

2.00pm – 3.15pm: Discussion Session 1.

Facilitators Neil Wayman: AstraZeneca UK, Chairman of PQG: Pharmaceutical Quality Group and Una Hearty Pfizer Ireland: representing the PHSS Annex 1 focus group. Discussion format:

  • Discussion on prepared/ selected questions on key concerns and comments on Annex 1 revision. Facilitators will introduce the questions with background information and open up discussion to the conference audience.
  • Discussion with open questions from the conference audience with responses from the MHRA and Pharma Industry representing the PHSS Annex 1 focus group.

3.15pm – 4.30pm: Discussion Session 2.

Facilitators Mike Davies: GSK UK Director, Aseptic Strategy & Intelligence Pharma Ops Global Functions, Co-leader of PHSS Aseptic processing and Bio-contamination special interest group & member of PHSS Annex 1 focus group.

James Drinkwater: Chairman of PHSS, F Ziel GmbH Head of GMP Compliance, Co-leader of PHSS Aseptic processing and Bio-contamination special interest group & PHSS Annex 1 focus group and member of PQG.

  • Discussion on prepared/ selected questions on key concerns and comments on Annex 1 revision. Facilitators will introduce the questions with background information and open up discussion to the conference audience.
  • Discussion with open questions from the conference audience with responses from the MHRA and Pharma Industry representing the PHSS Annex 1 focus group.

Conference Close & Thanks 4.30pm: PHSS & PQG Chairman

http://phss.co.uk/


Tuesday, 21 November 2017:
MHRA GMDP Symposium London Tuesday 21 November - Friday 24 November 2017

PQG committee members will be hosting a stand for the 4 days Tuesday 21st – Friday 24th, at the MHRA GMDP Symposium in London.

Come and meet us to hear our plans for the coming year and how you could be involved.  We are currently updating our website, and have teams developing new monographs. Find out how much time would be involved in volunteering to join one of the teams as we know, like us, you all have day jobs too.  There are significant benefits both personally and for your organisation if you help develop monographs, so do come and talk to us if this might be of interest to you.

 


Wednesday, 11 October 2017:
Day 3

Option 8 Book Wednesday 11th October


Tuesday, 10 October 2017:
Day 2 + Day 3

Option 6 Book Tuesday 10th + Wednesday 11th October


Tuesday, 10 October 2017:
Day 2

Option 7 Book Tuesday 10th October


Monday, 9 October 2017:
The PQG 40th Anniversary

40th Anniversary Bookings now closed.

Hilton Hotel, Timbold Drive, Milton Keynes MK7 6HL.

Click here for directions

Click here for Agenda

The cost of each meeting does include a hot lunch with choices (a vegetarian option is available) and tea/coffee at breaks.

Day 1 Monday 9th October

Trainee QP, Sponsors & QP CPD Day

This seminar is aimed at QPs, trainee QPs and their sponsors. The day will include a Legislative update from NSF’s Pete Gough to enable participants to keep up to date with the changing world of pharmaceuticals. We will also be aiming to provide support and advice on how to prepare for and pass your VIVA.

  • Welcome & introduction Stephan Croft & Damian Larrington (PQG & Pfizer)
  • What should you do to prepare for your VIVA? – Damian Larrington 
  • Submitting for the VIVA and what is the VIVA like on the day – Alex Kersting (RSC)
  • What does the QP assessor want to see and hear? Alex Hall (QPQuandary)
  • Regulatory update – Pete Gough (Executive Director – NSF)
  • Viva practice – Pete Gough, John Johnson (NSF) Stephan Croft and Damian Larrington
  • QP Scenarios – Real life examples to help prepare for your VIVA – (Ian Pardo, QP & Sr Manager – Pfizer)

Day 2 Tuesday 10th October

Session 1 – Annex 1  workshops James Drinkwater (Chairman PHSS) + Andy Hopkins (MHRA) 

  • The management of change
  • Confirmed changes and impact to the QP
  • Expectation of implementation / timelines
  • Impact to QMS
  • Impact to equipment, utilities,facilities
  • Impact to Marketing Authorisations
  • Continuity of supply

Session 2 Serialization Update David Waddington (NSF)

  • How it will be implemented? The equipment, software, validation and realistic timelines.

Session 3 The problem with problem solving – Dominic Parry (Inspired Pharma Training)

  • Root cause analysis, human error, CAPA, effectiveness checks & metrics.

Session 4: – Alex Hall – (QP Quandary & RSSL)

  • QP Declarations, Changes in regulatory expectations and examples of issues faced in real life.

Day 2 – evening session

Technical issues and how to deal with them as a QP (soft skills etc)

Day 3 Wednesday 11th October

Industry meeting and education

  • Session 1       GMDP interface, RP, QP, QMS – Simon Baker (Pfizer) Alex Hall (QP Quandary & RSSL)
  • Session 2       Legislative update – Pete Gough (NSF)
  • Session 3       Best practice behaviours for perpetual GMP compliance – John Johnson (NSF)
  • Session 4       Brexit – The practical impact on the UK pharmaceutical industry –  Mark Manson (ABPI)
  • Session 5       Data integrity 2 years on. An overview of data integrity since MHRA guidance has been published, common inspection findings, challenges and future expectations –  Tracy Moore (MHRA)

More Speakers and details for the agenda will follow soon.

PQG have negotiated a discounted room rate for a limited number Monday 9th October £99 and Tuesday 10th £129. Click here to book a room at the special rate

There are of course many other hotels in Milton Keynes:

Premier Inn Lakeside Grove Caldecotte (1.7 miles from Hilton)

Travel Lodge Milton Keynes at the Hub ( 4 miles from Hilton)

Holiday Inn Express (2.8 miles from Hilton)

To contact the meeting organiser: e-mail admin@pqg.org


Monday, 9 October 2017:
Trainee QP, Sponsors & QP CPD Day

Option 2 Book Monday 9th October only.


Monday, 9 October 2017:
Trainee QP, Sponsors & QP CPD Day + Dinner

Option 3 Book Monday 9th & Dinner


Monday, 9 October 2017:
40th Anniversary Day 1 + Day 2

Option 4 Book Monday 9th & Tuesday 10th October


Monday, 9 October 2017:
Day 1, Day 2 + Dinner

Option 5 Book Monday 9th, Tuesday 10th + Dinner


Monday, 9 October 2017:
Anniversary Dinner

Option 9 Book Anniversary Dinner only.


Tuesday, 25 April 2017:
Making Pharmaceuticals Free 2 Day Event

2 Day Event 25th & 26th April 2017, Ricoh Arena, Coventry.

According to the publicity material Making Pharmaceuticals is “the only dedicated FREE TO ATTEND event in the UK that addresses the detailed and complex issues associated with sourcing, manufacturing, outsourcing and delivering consistent pharmaceutical products to the market”.

PQG speakers will be presenting on Tuesday 25th April.

14.00 – 14.20 David Abraham Latest Developments in Packaging Materials GMP Standard -PS 9000
14.20 – 14.40 Esme Gibb Focus for the Pharma Industry – Data Integrity
14.40 – 15.00 Steve Moss Pharmaceutical Quality Group – Supporting the Industry

For details of the many seminars and workshops please see the event website: http://www.making-pharma.com/

All bookings and enquiries must be made via the meeting organiser.


Wednesday, 5 April 2017:
Trainee QP, Sponsors & QP CPD Day

Date: Wednesday 5th April 2017

Location: Hamilton House, Mabledon Place, London, WC1H 9BD. Nearest stations, Kings’s Cross, Euston and St Pancras. Hamilton House Location

Meeting begins: 09:00, ending at 17:00

This seminar is aimed at QPs, trainee QPs and their sponsors. The day will include a Legislative update from NSF’s Pete Gough to enable participants to keep up to date with the changing world of pharmaceuticals. We will also be aiming to provide support and advice on how to prepare for and pass your VIVA.

09:00 Registration and coffee
09:25 Introduction Damian Larrington (PQG and Pfizer)
09:30 What should you do to prepare for your VIVA? – Damian Larrington (PQG and Pfizer)
09:45 Submitting for the VIVA and what is the VIVA like on the day – Alex Kersting (RSC)
10:20 What does the QP assessor want to see and hear? John Johnson (NSF & former QP Assessor)
11:00 Coffee/tea break
11:15 Regulatory update – Pete Gough (Executive Director – NSF)
12:45 Lunch
13:30 Viva practice – Pete Gough, John Johnson, Stephan Croft and Damian Larrington
15:30 Coffee/tea break
15:45 QP Scenarios – Real life examples to help prepare for your VIVA
16:45 Closing comments – Damian Larrington
17:00 Close

The meeting will also provide an ideal forum for discussion, an excellent opportunity to network with other QPs and will count towards your CPD.

The cost of the meeting includes a cold buffet lunch (with vegetarian options) and tea/coffee at breaks.

To book your place and pay by Credit Card, click on the green button at the top of this advert.

Confirmation of your place and VAT receipt: You will receive this by e-mail within a week of booking your place. A certificate of attendance will be provided at the meeting for your CPD records.

To contact the meeting organiser: e-mail admin@pqg.org

 


Thursday, 30 March 2017:
Data Integrity Workshop SHEFFIELD

Date: Thursday 30th March 2017

Location: Quality Context 79 Leigh Street, Sheffield, S9 2PR  Click here for directions to Quality Context Leigh Street or email admin@pqg.org to ask for information.

Meeting begins: 10:00, ending at 16:00

Organised by PQG in conjunction with RQA, this is a workshop event – there will be key note presentations from David Thompson (Clarity Compliance Solutions) and Russell Joyce (Scientific Archivists Group), but the majority of the event will be group discussions on specific issues raised by those attending (you will be sent a questionnaire after signing up to attend and responses will be used by the facilitators (Phil Butson and Kate Krachai) to drive the discussions).  The event will therefore be of most benefit to those who are actively involved in the interpretation and implementation of the various regulatory data integrity documents rather than those who want to be taught what they say.

The same workshop was held in London earlier this month prompting the following positive feedback:

“Interesting to hear real life experience (not just hypothetical)”

“Meta data is always hard to define – this did it very clearly and made its usefulness apparent”

“Listening through the real life example – brilliant! Direct from the QP from start to finish, passion, ownership and pride in what was found and outcome”

“Very powerful.  Great to be able to be so transparent on such a significant issue”

“Excellent discussion, very valuable hearing about other pharma questions”

“An excellent workshop full of useful information”

To book your place and pay by Credit Card, click on the green button at the top of this advert.

RQA members who are not members of PQG: Please email Sarah on admin@pqg.org with details of your RQA membership and, after confirming your details with RQA office, she will contact you to explain how you can pay to attend the event at the member’s rate.

Confirmation of your place and VAT receipt: You will receive this by e-mail within a week of booking your place. A certificate of attendance will be provided at the meeting for your CPD records.

To contact the meeting organiser: e-mail admin@pqg.org


Tuesday, 14 March 2017:
The PQG Annual General Meeting (PQG Members only)

Date: Tueday 14th March 2017
Location: Ironmonger’s Hall Barbican London http://www.ironmongers.org/venue_map.htm.
This meeting will begin at approx 9:30 and end by 10:45

PQG members do not need to book for this part of the meeting


Tuesday, 14 March 2017:
The 20th Annual Discussion Meeting with the MHRA for QPs, QA Managers and their colleagues (open to Non Members)

Date: Tuesday 14th March 2017
Location: Ironmonger’s Hall Barbican London http://www.ironmongers.org/venue_map.htm.

This meeting will begin at approximately 11:00 and end by 16:30

This year we are introducing some new ideas to the Discussion meeting. We plan to focus on subjects of particular relevance from the past year. There will be table discussions on case studies, followed by feedback from the Inspectors. Further details will be available soon. There will still be the usual Q&A session, so please submit your questions as soon as you can.

Questions: As in previous years, questions on any aspects of GMP from the audience will be discussed openly.

We are again asking attendees to submit questions to admin@pqg.org well in advance to allow sufficient time for MHRA to review and collate responses. Consequently, we will take questions from now until 3rd February 2017. After that questions can only be asked if there is time on the day.

To book your place and pay by Credit Card, click on the green button above in this advert.

Early booking is advised: As this is a very popular meeting, early booking is advisable.

To facilitate participation and open discussion, numbers will be strictly limited to 50 attendees.

To contact the meeting organiser: e-mail admin@pqg.org

Confirmation of your place and VAT receipt: You will receive this by e-mail within a week of booking your place. A certificate of attendance will be provided at the meeting for your CPD records.


Thursday, 9 March 2017:
Data Integrity Workshop LONDON

Date: Thursday 9th March 2017

Location: CCTV Barbican London Click here for directions to CCTV Barbican 

Meeting begins: 10:00, ending at 16:00

Organised by PQG in conjunction with RQA, this is a workshop event – there will be key note presentations from David Thompson (Clarity Compliance Solutions) and Russell Joyce (Scientific Archivists Group), but the majority of the event will be group discussions on specific issues raised by those attending (you will be sent a questionnaire after signing up to attend and responses will be used by the facilitators (Phil Butson and Kate Krachai) to drive the discussions).  The event will therefore be of most benefit to those who are actively involved in the interpretation and implementation of the various regulatory data integrity documents rather than those who want to be taught what they say.

To book your place and pay by Credit Card, click on the green button at the top of this advert.

RQA members who are not members of PQG: Please email Sarah on admin@pqg.org with details of your RQA membership and, after confirming your details with RQA office, she will contact you to explain how you can pay to attend the event at the member’s rate.

Confirmation of your place and VAT receipt: You will receive this by e-mail within a week of booking your place. A certificate of attendance will be provided at the meeting for your CPD records.

To contact the meeting organiser: e-mail admin@pqg.org


Wednesday, 8 February 2017:
Visit to PQ Silicas, Warrington – The challenge of meeting API & Excipient GMPs - joint meeting with EXCiPACT

Date:Wednesday 8th February 2017

Meeting begins:10:00 registration for 10:30 start; finish by 15:30

Location: PQ Silicas UK Limited, Bank Quay, 4 Liverpool Road, Warrington, Cheshire WA5 1AB

 

Location PQ Silicas Warrington

Agenda:

10:00 Registration and coffee.
10:30  PQ Silicas introduction – agenda for day.
10:35 Welcome to site with overview presentation from site representative: presenting the company, the Warrington site and key topics of interest.
11:00 Site tour.
12:30 Lunch.
13:30 Questions & Answers from site & short discussion on topic of interest – The challenge of meeting API & Excipients GMP.
14:30 EXCiPACT presentation/discussion – Tony Scott (Head of Operations).
15:30 Close

To book your place and pay by Credit Card, click on the green button at the top of this advert.

Confirmation of your place and VAT receipt: You will receive this by e-mail within a week of booking your place. A certificate of attendance will be provided at the meeting for your CPD records.

To contact the meeting organiser: e-mail admin@pqg.org


Wednesday, 2 November 2016:
Trainee QP, Sponsors & QP CPD Day

Date: Wednesday 2nd  November 2016
Location: CCTV Barbican London Click here for directions to CCTV Barbican 
Meeting begins: 09:00, ending at 17:00

This seminar is aimed at QPs, trainee QPs and their sponsors. The day will include a Legislative update from NSF’s Pete Gough to enable participants to keep up to date with the changing world of pharmaceuticals. We will also be aiming to provide support and advice on how to prepare for and pass your VIVA.

Agenda:

09:00 Registration and coffee
09:25 Introduction Damian Larrington ( PQG and Pfizer)
09:30 What should you do to prepare for your VIVA? – Damian Larrington (PQG and Pfizer)  
10:00 What does the QP assessor want to see and hear? (John Johnson NSF, former QP assessor
10:45 Submitting for the VIVA and what is the VIVA like on the day –Alex Smith RSC
11:15 Coffee/tea break
11:30 Regulatory update – Pete Gough (Executive Director – NSF)
12:45 Lunch
13:30 Viva practice – John Johnson, Pete Gough and Damian Larrington

  • Oral solid dose
  • Sterile
  • IMP
  • Pharmaceutical law
15:30  Coffee/tea break
15:45 QP Scenarios – Real life examples and how you would respond in your VIVA
16:45 Closing comments – Damian Larrington
17:00 Close

The meeting will also provide an ideal forum for discussion, an excellent opportunity to network with other QPs and will count towards your CPD.
The cost of the meeting includes lunch (a vegetarian option is available) and tea/coffee at breaks.

To book your place and pay by Credit Card, click on the green button at the top of this advert.
Confirmation of your place and VAT receipt: You will receive this by e-mail within a week of booking your place. A certificate of attendance will be provided at the meeting for your CPD records.
To contact the meeting organiser: e-mail admin@pqg.org


October 2016:
Investigational Medicinal Product Supply Chain

This meeting is now being postponed until 2017.

This meeting will be run jointly with RQA and will look at some of the supply chain risks and challenges associated with investigational medicinal products.  Date to be confirmed. Agenda to follow.


Thursday, 14 July 2016:
PS 9000:2016 Pharmaceutical Packaging Materials for Medicinal products (GMP) Update Standard

Date: Thursday 14th July 2016

Meeting begins: 09:30 registration for 10:00 start; finish by 16:15

Location: Council Chamber, Royal College of Physicians, 11 St Andrews Place, Regent’s Park, London, NW1 4LE

http://www.rcpevents.co.uk/contact-us

The PQG, in collaboration with the pharmaceutical industry, suppliers and International Pharmaceutical Aerosol Consortium on Regulation and Science (IPAC-RS) has developed the next generation of the well-established PS 9000 series of standards.

This event offers Quality Professionals across the industry an insight to this updated PS 9000 version of the standard, which has been revised based on the ISO 9001:2015 framework to deliver quality management systems,with updated and enhanced additional requirements, together with guidance which reflects Good Manufacturing Practice in the supply of pharmaceutical packaging materials.

Event attendees will have the opportunity to hear from speakers from the project team, MHRA and IPAC-RS about the changes introduced by the new structure, and how the revised standard targets expectations and risks in a global packaging supply chain.

Complimentary copies of the new publication will be available for attendees (subject to availability).

The agenda, as below represents the structure of the meeting:

09:30 Registration and Coffee
10:00 Chairman’s Introduction
10:15 PS 9000:2016 Application Standard
10:40 PS 9000:2016 – What has changed?
11:05 Coffee/Tea Break
11.20 Primary and Complex Components
11:45 Packaging Supply Chain Risks
12:10 Regulatory Perspective – MHRA
12:45 Questions
13:00 Lunch
14:00 The Importance of Training in Compliance
14:25 PQG Supplier Certification
14:50 Supplier Perspective – Secondary Packaging
15:15 Questions
15:30 Refreshments and Close

The PQG looks forward to receiving bookings and your involvement with this industry meeting.

To book your place and pay by Credit Card, click on the green button at the top of this advert.
Confirmation of your place and VAT receipt: You will receive this by e-mail within a week of booking your place. A certificate of attendance will be provided at the meeting for your CPD records.

To contact the meeting organiser: e-mail admin@pqg.org


Tuesday, 26 April 2016:
Making Pharmaceuticals Free 2 Day Event

2 Day Event 26th & 27th April 2016, National Conference Centre, Birmingham

PQG speakers are presenting on the second day of Making Pharmaceuticals which, according to the publicity material “is the only dedicated FREE TO ATTEND event in the UK that addresses the detailed and complex issues associated with sourcing, manufacturing, outsourcing and delivering consistent pharmaceutical products to the market”. There are 70+ seminars and workshops covering a wide range of topics, and 100+ exhibitors.

27th April

15.00 – 15.20 Supply chain risk management – the weakest link Steve Moss
15.20 – 15.40 Latest developments in packaging materials GMP standard – PS 9000 David Abraham
15.40 – 16.00 Focus for pharma industry – data integrity Esme Gibb

For more details please see the event website: http://www.making-pharma.com/

All bookings and enquiries must be made via the meeting organiser.


Wednesday, 23 March 2016:
Trainee QP, Sponsors & QP CPD Day

Date: Wednesday 23rd March 2016
Location: Hamilton House, Mabledon Place, London, WC1H 9BD.Nearest stations Kings’s Cross, Euston and St Pancras. Hamilton House Location
Meeting begins: 09:00, ending at 16:45

This seminar is aimed at QPs, trainee QPs and their sponsors.

Agenda

09:00 Registration and coffee
09:25 Introduction Stephan Croft (PQG & EMEA Quality Director – Hospira)
09:30 Preparation & Training: Study Guide, Gap Analysis & Execution –
Damian Larrington (PQG & EMEA QA Batch Release Manager & Continuous Improvement – Hospira)
& Stephan Croft.
DL – Preparing for the journey, time, commitment, life change,education and mind set.
SC – How to be a sponsor, pick the right person, guide them through and what happens after.
10:30 QP Application Process – Kim Smith (Registration Officer, Royal Society of Chemistry)
11:00 Coffee/Tea Break
11:15 QP Assessment Process – Andrea Kingsland-Innwood (QP Assessor for the Society of Biology & Interim Quality Management Ltd)
11:45 Regulatory update – Pete Gough (Executive Director – NSF)
13:00 Lunch
13:45 VIVA preparation – How should you answer those questions – All presenters
15:00 Coffee break
15:15 QP Scenarios – Real life examples and how you would respond in your VIVA
16:30 Closing comments – Stephan Croft
16:45 Close

 

The meeting will also provide an ideal forum for discussion, an excellent opportunity to network with other QPs and will count towards your CPD.
The cost of the meeting includes lunch (a vegetarian option is available) and tea/coffee at breaks.

To contact the meeting organiser: e-mail admin@pqg.org

 

 


Tuesday, 15 March 2016:
The PQG Annual General Meeting (PQG Members only)

Date: Tueday 15th March 2016
Location: Ironmonger’s Hall Barbican London http://www.ironmongers.org/venue_map.htm
This meeting will begin at approx 9:30 and end by 10:45

PQG members do not need to book for this part of the meeting


Tuesday, 15 March 2016:
The 19th Annual Discussion Meeting with the MHRA for QPs,QA Managers and their colleagues (open to Non Members)

Date: Tuesday 15th March 2016
Location: Ironmonger’s Hall Barbican London http://www.ironmongers.org/venue_map.htm.

This meeting will begin at approximately 11:00 and end by 16:00

There will be an initial presentation by a Member of the MHRA Inspectorate followed by the discussion meeting and further information will be added when available.

Questions: As in previous years, questions on any aspects of GMP from the audience will be discussed openly.

We are again asking attendees to submit questions to admin@pqg.org well in advance to allow sufficient time for MHRA to review and collate responses. Consequently, we will take questions from now until 5th February 2016. After that questions can only be asked if there is time on the day.

To book your place and pay by Credit Card, click on the green button above in this advert.

Early booking is advised: As this is a very popular meeting, early booking is advisable.

To facilitate participation and open discussion, numbers will be strictly limited to 50 attendees and bookings will open soon.

To contact the meeting organiser: e-mail admin@pqg.org

Confirmation of your place and VAT receipt: You will receive this by e-mail within a week of booking your place. A certificate of attendance will be provided at the meeting for your CPD records.


Wednesday, 10 February 2016:
Introduction to Biologics including latest developments and regulatory changes

Date: Wednesday 10th February 2016

Meeting begins: 09:00 registration for 09:30 start; finish by 17:00

Location: The British Library, St Pancras Building, 96 Euston  Road,London NW1 2BD

http://www.bl.uk/aboutus/quickinfo/loc/stp/index.html

Introduction to Biologics including latest developments and regulatory changes

09:30  Coffee and registration
10:00  Introduction to ECA
10:05  What is biotechnology?
10:45  GMP guidelines in biotechnology part I
11:15  Coffee
11:45  GMP guidelines part II
12:15  GMP for master and working cell banks
13:00  Lunch
14:00  Manufacturing of biotech API – methods and challenges
15:00  Tea
15:30  Viral clearance
16:00  Wrap-up, further questions etc.

To book your place and pay by Credit Card, click on the green button at the top of this advert.
Confirmation of your place and VAT receipt: You will receive this by e-mail within a week of booking your place. A certificate of attendance will be provided at the meeting for your CPD records.
To contact the meeting organiser: e-mail admin@pqg.org


Wednesday, 20 January 2016:
The revised EU GMP Annex 16 – Qualified Person Certification and Batch Release

Date: Wednesday 20th January 2016

Meeting begins: 09:00 registration for 09:20 start; finish by 17:00

Location: Museum of London,150 London Wall,London EC2Y 5HN
http://www.museumoflondon.org.uk/london-wall/visiting-us/getting-here

To hear the regulators view on the changes in the Annex and to bring out key points for discussion through engagement with attendees .

The workshop sessions will involve work in small groups to maximise sharing of views and possible solutions to areas that might be challenging to implement. Workshop titles in the outline agenda are based on areas considered likely to be of interest to the industry.

MHRA’s Tracy Moore and Trevor Watson will be in attendance to provide an MHRA perspective whilst the experienced industry speakers are mostly yet to be confirmed.

Agenda

09:00 Arrival/registration/coffee
09:20  Chair’s welcome
09:30 The revised Annex 16 – A Regulatory Agency Inspector’s viewpoint – Tracy Moore  MHRA
10:00 The revised Annex 16 – A first impression from industry -Andrea Kingsland-Inwood
10:30 Q&A on first two presentations
11:00 Coffee break/Networking
11:20 Introduction to workshop sessions
11:30 Workshop Session 1: Supply Chain Maps – Phil Butson PQG
12:30 Lunch/networking
13:30 Workshop Session 2: Import Testing Requirements – Helena McGarr GSK
14:30 Workshop Session 3: Impact on Outsourced Activities – Stephan Croft & Damian Larrington
15:30 Coffee break/networking
15:45 Workshop Session 4: Handling of unplanned deviations – Stephan Croft & Damian Larrington
16:45 Q&A/feedback time
17:00 Close

To book your place and pay by Credit Card, click on the green button at the top of this advert.
Confirmation of your place and VAT receipt: You will receive this by e-mail within a week of booking your place. A certificate of attendance will be provided at the meeting for your CPD records.
To contact the meeting organiser: e-mail admin@pqg.org

 


Thursday, 26 November 2015:
Trainee QP meeting/site visit

Date: Thursday 26th November 2015
Location: AstraZeneca Charter Way, Silk Road Business Park, Macclesfield, Cheshire SK10 2NA
Meeting begins: 09:30 registration for 10:00 start; finish by 15:45

The PQG have arranged a Company visit to AstraZeneca, Cheshire. Click here for a map and directions.

Agenda:

09:30 – 10:00 Registration and coffee
10:00 – 10:15 Welcome & Introduction
10:15 – 10:45 Introduction to aseptic manufacture
10:45 – 11:00 Overview of SPP5 facility
11:00 – 11:15 Coffee/Tea Break
11:30– 12:45 Facility tours and workshops
12:45 – 13:15 Lunch
13.15 – 13:45 Cleanroom behaviours and aseptic practices
13.45 – 14:30 Design and build of a sterile facility
14:30 – 14:45 Coffee/Tea Break
14:45 – 15:15 QP challenges
15:15 – 15:45 Questions & Meeting Close

Early booking is advised due to the limited availability of this visit to the first 40 delegates.
The cost of the meeting includes lunch (a vegetarian option is available) and tea/coffee at breaks.

Please note the dress code for the meeting is trousers and long sleeve tops due to the facility still being a construction area.

To book your place and pay by Credit Card, click on the green button at the top of this advert.
Confirmation of your place and VAT receipt: You will receive this by e-mail within a week of booking your place. A certificate of attendance will be provided at the meeting for your CPD records.
To contact the meeting organiser: e-mail admin@pqg.org


Thursday, 14 May 2015:
Complaints, Quality Defects and Product Recalls – the revised EU GMP Chapter 8

Date: Thursday14th May 2015
Location: Ironmonger’s Hall Barbican London
Meeting begins: 08:45 registration for 09:15 start; finish by 16:15

http://www.ironmongers.org/venue_map.htm

The PQG Chapter 8 meeting represents an excellent opportunity to learn about the new chapter and how various organizations outside your own  have interpreted and implemented the associated changes.   In addition, the event attendees will have a fabulous opportunity to learn about the requirements for reporting and managing recalls within the Irish Market as presented by a speaker from HPRA (Formally IMB), which will ensure best practice is applied and compliance maintained.

Do not miss out on this fantastic opportunity to learn and explore aspects of the new Chapter 8.

Headline Speakers:

  • Rob Smyth (Market Compliance Scientific Officer – HPRA)
  • Alex Hall (QP Quandry Ltd)
  • Ian Pardo (Circassia Pharmaceuticals plc)
  • Stephan Croft (PQG, EMEA QA Director – Hospira)
  • Damian Larrington (PQG, Pharma Quality Professionals Ltd)

The key notes from the HPRA presentation is expected to include (Subject to change):

Introduction

  • Who we (the QDR group) are and what we do
  • Defect and Recall Stats for the Irish market
  • Scope (various stakeholders affected)

Overview of Chapter 8 changes – which apply to QDRs and how?

Defect Investigation

  • Information gathering
  • Reporting of defects

Recalls

  • HPRA Requirements
  • Best Practices

The agenda, as below represents the structure of the meeting and also elements of the new Chapter 8:

Agenda:

08:45-09:15 Registration & coffee
09:15-09:30 Welcome and introduction
09:30-10:00 Personnel & Organization
10:00-10:30 Procedures for handling and investigating complaints including possible quality defects (QA Manager – Circassia Pharmaceuticals plc)
10:30-10:45 Coffee break
10:45-11:15 Investigation and Decision-making & Root Cause Analysis and Corrective and Preventative Actions– Alex Hall (QP Quandry Ltd)
11:15-12:30 HPRA (Formally IMB): Quality Defect Investigations and Recalls on the Irish Market’ – Rob Smyth (Market Compliance Scientific Officer – HPRA)
12:30-01:15 Lunch
13:15–14:15 Product Recalls, other potential risk-reducing actions & Impact on the distribution chain  -Stephan Croft (PQG, EMEA QA Director  -Hospira)
14:15:15:00 Group Workshop  / Scenario– Alex Hall (QP Quandry Ltd)
15:00-15:15 Coffee break
15:15-16:00 What makes a good recall SOP and Process? –  Stephan Croft
16:00-16:15 Final comments and meeting close

The PQG looks forward to receiving bookings and your involvement with this industry meeting.

To contact the meeting organiser: e-mail Admin@pqg.org

Confirmation of your place and VAT receipt: You will receive this by e-mail within a week of booking your place. A certificate of attendance will be provided at the meeting for your CPD records.


Wednesday, 13 May 2015:
Cleaning and the prevention of cross-contamination (Revised EU GMP Chapters 3 and 5)

Date: Wednesday 13th May 2015
Location: Ironmonger’s Hall Barbican London
Meeting begins: 09:00 registration for 09:30 start; finish by 16:30

http://www.ironmongers.org/venue_map.htm

The 2014 revision of EU GMP Chapters 3 and 5, together with the November 2014 guideline on health-based cleaning limits, include some significant changes regarding the prevention of cross-contamination and assurance of cleaning.  In addition, MHRA identified cross-contamination as one of the key areas of concern in their review of 2013 deficiency data.  This meeting will look at the revisions and how to put these requirements into practice to ensure compliance and, most importantly, safeguard the patients we serve. The agenda below is subject to change.

Agenda:

09:00 Registration & coffee
09:30 Welcome/housekeeping, then straight in with Chapters 3 & 5 – what has changed and regulatory findings – Phil Butson
10:00 Establishing a risk assessment of facility design and controls – Ian Birch
11:30 Coffee break
11:50 Auditing for cross-contamination risks – what to look out for – Brian Hammond
12:50 Revision of the PQG Cleaning & Cleaning Validation monograph – Phil Butson
13:00 Lunch
14:00 Health-based cleaning limits – a toxicologist’s perspective – Chris Seaman
14:45 Cleaning verification & validation in practice in an R&D facility – Laura Rutter
15:30 Tea break
15:45 Panel Q&A session
16:30 Meeting close

To contact the meeting organiser: e-mail Admin@pqg.org

Confirmation of your place and VAT receipt: You will receive this by e-mail within a week of booking your place. A certificate of attendance will be provided at the meeting for your CPD records.


Tuesday, 28 April 2015:
Making Pharmaceuticals Free 2 Day Event

A 2-day Meeting with Seminars & Exhibition that is FREE TO ATTEND
Dates: 28 – 29 April 2015
Venue: NMM Exhibition Centre Birmingham, UK

All bookings and enquiries must be made via the meeting organiser.

Click here to register:


Wednesday, 15 April 2015:
Trainee QP, Sponsors & QP CPD Day

Date: Wednesday 15th April 2015
Location: CCTV Barbican London
Meeting begins: 09:00, ending at 16:15

http://www.cctvenues.co.uk/images/stories/traveldirections/new_barbican%20traveldirectionsdec2013.pdf

This seminar is aimed at QPs, trainee QPs and their sponsors.

Agenda:

09:00 Registration and coffee
09:25 Introduction Stephan Croft (PQG & EMEA Quality Director – Hospira)
09.30 Preparation & Training: Study Guide, Gap Analysis & Execution  – Damian Larrington (PQG & EMEA QA Batch Release Manager & Continuous Improvement – Hospira) & Stephan Croft.
10.00 QP Application Process – Alex Kersting (Registration Officer, Royal Society of Chemistry)
10:30 Coffee/Tea Break
10.45 QP Assessment Process – Andrea Kingsland-Innwood (QP Assessor for the Society of Biology &  Interim Quality Management Ltd)
11:15 Regulatory update – Pete Gough (Executive Director – NSF)
12.30 Lunch
13:30 QP Scenario Session
14.45 Coffee
15.00 MHRA QP Hot Topic: Data Integrity – David Churchward (Expert GMDP Inspector- MHRA)
16.00 Closing comments – Stephan Croft
16.15 Close

The meeting will also provide an ideal forum for discussion, an excellent opportunity to network with other QPs and will count towards your CPD.
The cost of the meeting includes lunch (a vegetarian option is available) and tea/coffee at breaks.

To contact the meeting organiser: e-mail admin@pqg.org


Tuesday, 17 March 2015:
The PQG Annual General Meeting (PQG Members only)

Location: CCTV Barbican, London. http://www.cctvenues.co.uk/images/stories/traveldirections/new_barbican%20traveldirectionsdec2013.pdf

This meeting will begin at approximately 09:30 and end by 10:45.

PQG members do not need to book for this part of the meeting.


Tuesday, 17 March 2015:
The 18th Annual Discussion Meeting with the MHRA for QPs,QA Managers and their colleagues (open to Non Members)

Location: CCTV Barbican, London. http://www.cctvenues.co.uk/images/stories/traveldirections/new_barbican%20traveldirectionsdec2013.pdf

This meeting will begin at approximately 11:00 and end by 16:00

There will be an initial presentation by a Member of the MHRA Inspectorate followed by the discussion meeting and further information will be added when available.

Questions: As in previous years, questions on any aspects of GMP from the audience will be discussed openly.

We are again asking attendees to submit questions to Admin@pqg.org well in advance to allow sufficient time for MHRA to review and collate responses. Consequently, we will take questions from now until 2th February 2015. After that questions can only be asked if there is time on the day.

To book your place and pay by Credit Card, click on the green button above in this advert.

Early booking is advised: As this is a very popular meeting, early booking is advisable.

To facilitate participation and open discussion, numbers will be strictly limited to 50 attendees and bookings will open soon.

To contact the meeting organiser: e-mail Admin@pqg.org

Confirmation of your place and VAT receipt: You will receive this by e-mail within a week of booking your place. A certificate of attendance will be provided at the meeting for your CPD records.


Monday, 17 November 2014:
PS 9000:2015 The next generation in packaging GMP

The cost of the meeting is just a nominal charge towards lunch.

Date: Monday 17th November 2014
Location: The Chartered Quality Institute, 2nd Floor North, Chancery Exchange 10 Furnival Street London EC4A 1AB
Meeting begins: 10:30, ending at 15:00

http://www.thecqi.org/The-CQI/About-us/How-to-find-the-CQI/

The global platform in Pharmaceutical and Healthcare supply chain continued to evolve and generate fresh challenges in the world of supply chain globalisation,  e.g. EU Directives (Falsified Medicines Directive), safeguarding against counterfeiting to name a few.

In light of this the Pharmaceutical Quality Group (PQG), in collaboration with industry stakeholders, is setting out a project to review, revise and update the pharmaceutical packaging supply standards(PS 9000) to continue to build on a highly established framework for the pharmaceutical packaging supply industry.

We are pleased to announce that we plan to hold a meeting in November at the CQI in London, to present the project vision and strategy as well as drawing upon the respective talents and strengths of industry experts to help shape this significant development for pharmaceutical packaging standards.

The response to the initial poll was extremely positive and we would thank all members who contributed, as a result we would recommend booking early as spaces are limited.

To facilitate participation and open discussion, numbers will be strictly limited to 30 attendees.

To contact the meeting organiser: e-mail admin@pqg.org 

 


Tuesday, 4 November 2014:
The revised EU Good Distribution Practice Guideline - 1 Year On

Date: Tuesday 4th November 2014
Location: CCTV Smithfield London
Meeting begins: 09:00, ending at 16:00

http://www.pqg.org/pharma/wp-content/uploads/2011/06/CCTV-Smithfield-Location.pdf

This meeting, brought to you by the team delivering the joint PQG/ECA guidance on Good Distribution Practice (GDP), will comprise a mixture of presentations and workshops looking at the 2013 EU GDP Guideline, its interpretation and practical implementation.

Agenda:

09:00 – 09:30 Registration and coffee
09:30 – 09:40 Chair’s welcome Ashley McCraight
09:40 – 10:00 ECA/PQG guidance/monograph project – what, why and how Afshin Hosseiny
10:00 – 10:40 Quality Management System Member of team
10:40 – 11:20 A regulator’s viewpoint (on the 2013 revision of the EU GDP guideline and the need for further guidance) Steve Todd, MHRA
11:20 – 11:40 Break/Networking
11:40 – 12:00 Personnel Sue Mann
12.00 – 12:20 Cogent Gold Standard for Responsible Persons Phil Bather
12:20 – 12:30 Panel questions on morning presentations
12:30 – 13:30 Lunch/Networking
13:30 – 14:10 Operations Mike Regan
14:10 – 14:50 Outsourced activities Neil Wayman
14:50 – 15:10 Break/Networking
15:10 – 15:50 Transportation Ciaran Brady
15:50 – 16:00 Panel questions on afternoon presentations
16:00 Close Ashley McCraight

 

 

The event fee is £150 plus VAT for PQG members.

 

To contact the meeting organiser: e-mail admin@pqg.org


Wednesday, 21 May 2014:
Discussion Meeting for QPs, Trainee QPs and their Sponsors

Date: Wednesday 21st May 2014
Location: CCTV Smithfield London
Meeting begins: 08:30, ending at 16:30

http://www.pqg.org/pharma/wp-content/uploads/2011/06/CCTV-Smithfield-Location.pdf

This seminar is aimed at QPs, trainee QPs and their sponsors.

Agenda:

08:30 – 09:00 Registration and coffee
09:00 – 09:15 Welcome & Introductions
09:15 – 10:00 Trainee QP & Sponsor preparation, execution and review: Study guide & Gap Analysis Stephan Croft, Allergan & PQG
10:00 – 10:45 QP Application & Viva process Dr Jane McLauchlin, Registration Officer, Royal Society of Chemistry
10:45 – 11:00 Coffee  Break
11:00 – 12:15 Regulatory Update Pete Gough, Executive Director of Pharma Biotech, NSF Health Sciences UK
12:15 – 13:00 Lunch
13.00 – 13:45 The QP and the Quality Management System Dominic Parry, Director – Inspired Pharma Training
13:45 – 15:00 Workshops / Scenarios Barry Johnson, Director – Locum QP Ltd
15:00 – 15:20 Coffee  Break
15:20 – 16:15 Annex 13: QP Release of Investigational Medicinal Products Stephan Croft, Allergan & PQG
16:15 – 16:30 Questions, Wrap Up & Closing Remarks

 

 

 

 

 

 

 

 

 

The meeting will also provide an ideal forum for discussion, an excellent opportunity to network with other QPs and will count towards your CPD.
The cost of the meeting includes lunch (a vegetarian option is available) and tea/coffee at breaks.

To contact the meeting organiser: e-mail admin@pqg.org


Tuesday, 29 April 2014:
Making Pharmaceuticals Free 2 Day Event

A 2-day Meeting with Seminars & Exhibition that is FREE TO ATTEND
Dates: 28 – 29 April 2015
Venue: NMM Exhibition Centre Birmingham, UK

All bookings and enquiries must be made via the meeting organiser.

Click here to register:

 


Tuesday, 18 March 2014:
The PQG Annual General Meeting (PQG Members only)

Location: CCTV Barbican, London Click here for map and instructions

This meeting will begin at approx 9:30 and end by 10:45

PQG members do not need to book for this part of the meeting.

 


Tuesday, 18 March 2014:
The 17th Annual Discussion Meeting with the MHRA for QPs, QA Managers and their colleagues (open to Non Members)

Location: CCTV Barbican, London. Click here for instructions to find it

This meeting will begin at approximately 11:00 and end by 16:00

There will be an initial presentation by a Member of the MHRA Inspectorate followed by the discussion meeting and further information will be added when available.

Questions: As in previous years, questions on any aspects of GMP from the audience will be discussed openly.

We are again asking attendees to submit questions to  Admin@pqg.org well in advance to allow sufficient time for MHRA to review and collate responses. Consequently, we will take questions from now until 7th February 2014. After that questions can only be asked if there is time on the day.

To book your place and pay by Credit Card, click on the green button above in this advert.

Early booking is advised: As this is a very popular meeting, early booking is advisable.

To facilitate participation and open discussion, numbers will be strictly limited to 50 attendees.

To contact the meeting organiser: e-mail Admin@pqg.org

Confirmation of your place and VAT receipt: You will receive this by e-mail within a week of booking your place. A certificate of attendance will be provided at the meeting for your CPD records.


Friday, 7 March 2014:
Allergan Clinical Trial Packaging and Distribution Facility Visit for the Trainee QP & Interested Parties

Location: Allergan, Marlow International, Parkway, Marlow, Buckinghamshire, UK SL7 1YL. Click here for directions
Parking:  Some parking is available in the car park and also on the main road outside the building.

Meeting begins: 08:30 for a 09:00 start, ending at 17:00.

This meeting represents an opportunity to visit a secondary packaging and distribution facility for clinical trial materials.

Speakers:

  • Henryk Junker, Senior QA Manager & QP (Allergan)
  • Stephan Croft, QA Manager & QP (Allergan & PQG)
  • Damian Larrington, QA Officer (Allergan)
  • Jack Kelly, QA Officer (Allergan)
  • Laurence Punshon, Principle Specialist, Global Clinical Supplies (Allergan)

Agenda:

08:30 – 09:00 Registration and coffee
09:00 – 09:15 Welcome & Introduction to Allergan
09:15 – 10:15 Overview of Clinical Trial Packaging & Associated Annex 13 Requirements
10:15 – 10:45 Coffee/Tea Break
10:45 – 12:30 Facility tours and workshops
12:30 – 13:30 Lunch
13.30 – 14:30 QA/QP Release of Investigational Medicinal Products
14.30 – 15:30 Start Up, Transfer & Closure of a Clinical Trial Facility.
15:30 – 16:00 Coffee/Tea Break
16:00 – 16:45 Clinical Trial Packaging Design & Distribution
16.45 – 17:00 Questions & Meeting Close



The Pharmaceutical Quality Group will issue an attendance certificate for use in your Continuing Professional Development (CPD) programme. Early booking is advised due to the limited availability of this visit to the first 30 delegates.
The cost of the meeting includes lunch (a vegetarian option is available) and tea/coffee at breaks.

To book your place and pay by Credit Card, click on the green button at the top of this advert.
Confirmation of your place and VAT receipt: You will receive this by e-mail within a week of booking your place. A certificate of attendance will be provided at the meeting for your CPD records.
To contact the meeting organiser: e-mail admin@pqg.org


Wednesday, 27 November 2013:
Company Visit - Aesica Pharmaceuticals - Queenborough

The PQG have arranged a Company visit to Aesica Pharmaceuticals, Queenborough, Isle of Sheppey.

The main focus of the visit will be Continuous Tablet Manufacturing which has been implemented at the Queenborough site.

Please note that the meeting is free of charge, BUT it is reserved for MEMBERS of PQG ONLY

Location:  Aesica Pharmaceuticals, is in Queenborough, Isle of Sheppey and you can Click here to see a map and address.

Meeting begins: 10:00 for a 10:30 start, ending at about 15.30

Agenda:

10.00     Arrival / Refreshments

10.30     Introduction to site

10.45     Continuous tableting – Overview of facility Design & Operation

11.30     Tour of the Continuous Tabletting Line & the new High Capacity Manufacturing Facility

13.00     Buffet lunch & informal discussions

14.00     Presentation & Discussion: Cleaning Validation – Approach based on impending changes in the setting of Health-based exposure limits in shared Facilities

15.00     Q & A

15.30     Close

There is a limit of 30 attendees.

To book your place:  You MUST be logged in as a PQG Member, then click on the green button at the top of this advert.

Valid bookings will be confirmed by e-mail and non-valid bookings will be rejected.

Confirmation of your place:

You will receive a confirmation of your place by e-mail within one week of booking your place on the website.

A certificate of attendance will be provided at the meeting for your CPD records.

To contact the meeting organiser: e-mail admin@pqg.org


Wednesday, 16 October 2013:
PQG Seminar for QPs, Trainee QPs & their Sponsors

at CCT Venues, Smithfield, London

http://www.pqg.org/pharma/wp-content/uploads/2011/06/CCTV-Smithfield-Location.pdf

This seminar is aimed at QPs, trainee QPs and their sponsors. 

As well as presentations from QP Assesors and a Regulatory update, Richard Andrews & a GDP Inspector from the MHRA will be presenting the GDP Guidelines as relevant to the QP.

The meeting will also provide an ideal forum for discussion, an excellent opportunity to network with other QPs and will count towards your CPD.

The programme for the day is shown below:

09:00    Registration and coffee

09:25    Introduction:  Steve Moss, PQG Chairman

09.30    Trainee QP Preparation – Study Guide, Gap Analysis & Execution:  Stephan Croft (Allergan / PQG), Nick Hill (QP Assessor / Allergan)

10.00    QP Application & Assessment Process:  Jane McLauchlin – Registartion Officer, Royal Society of Chemistry 

10:30    Coffee/Tea Break

11.00    Annex 16 Update: Alex Hall (QPQuandary Ltd)

11:30    New GDP Guidelines – Overview & Application of the Guideline to the QP:   Richard Andrews (MHRA)

12.30    Lunch

13:15    QP Scenario Session:   James Culyer, Bard Pharmaceuticals Ltd, Barry Johnson, Locum QP Ltd

14.45    Coffee

15:00    Regulatory Update:  Samantha Clack (Quaph Consulting, PQG & NSF DBA)

16.10    Closing comments: Steve Moss, PQG Chairman

16.15    Close

The Pharmaceutical Quality Group will issue a Continuing Professional Development (CPD) Certificate at the meeting.

A VAT receipt will be provided within one week of your booking.

CCT Venues-Smithfield
Two East Poultry Avenue,
Smithfield, London, EC1A 9PT

http://www.pqg.org/pharma/wp-content/uploads/2011/06/CCTV-Smithfield-Location.pdf

Please contact Admin@pqg.org for any questions.

 


Tuesday, 4 June 2013:
Falsified Medicines Directive - Excipients formalised Risk Assessment

Location: CCTV Smithfield, London. Click here for instructions to find it

Meeting begins: 9:30 for 10:00 start and ending at 16:00

A PQG Discussion Meeting on

The Implementation of the “FORMALISED RISK ASSESSMENT FOR ASCERTAINING THE APPROPRIATE GOOD MANUFACTURING PRACTICE FOR EXCIPIENTS OF MEDICINAL PRODUCTS FOR HUMAN USE” of the Falsified Medicines Directive

The Falsified Medicines Directive (FMD) will have far reaching implications for the Pharmaceutical Industry, and specifically concerning the risk assessment for excipients:

The holder of the manufacturing authorisation shall ensure that the excipients are suitable for use in medicinal products by ascertaining what the appropriate good manufacturing practice is. This shall be ascertained on the basis of a formalised risk assessment in accordance with the applicable guidelines referred to in the fifth paragraph of Article 47. Such risk assessment shall take into account requirements under other appropriate quality systems as well as the source and intended use of the excipients and previous instances of quality defects. The holder of the manufacturing authorisation shall ensure that the appropriate good manufacturing practice so ascertained, is applied. The holder of the manufacturing authorisation shall document the measures taken under this paragraph 

Agenda:

The day’s programme will include presentations from:

Richard Andrews – MHRA and representatives from IPEC Europe, & EXCiPACTTM

As well as Workshop activities to:

  • Gain direct experience of applying the risk assessment process
  • Understand what is expected and ask for clarification for any areas of concern
  • Understand the implications regarding GMP for excipient companies

AGENDA FOR THE DAY

9.30 – 10.00  Registration & coffee  
10.00 – 10.15   Chairman’s introduction Phil Butson
10.15 – 10.45 Excpient GMPs

  • Which standards are applied for Excipients?
  • What is appropriate for Excipient GMPs?
Carl M’RozColorcon – IPEC Europe 
10.45 – 11.30 “Formalised Risk Assessment for ascertaining the appropriate Good Manufacturing Practice for Excipients of medicinal products for human use”.

  • Background, key requirements and current status
Richard Andrews, MHRA
11.30 – 12.15 “The holder of the manufacturing authorisation shall ensure that the appropriate good manufacturing practice so ascertained, is applied.”

  • Desk top assessments, site audits, certification schemes.
  • What are the consequences for the Excipient manufacturer and the user
Iain Moore Croda/IPEC Europe/Excipact
12.15 – 12.30  Discussion  
12.30 – 13.45  Lunch & opportunity for individual discussions  
13.45 – 14.00 “The holder of the manufacturing authorisation shall document the measures taken.”

  • What will MHRA inspectors look for during inspections of the MAH?
  • Implementation timelines
Richard Andrews, MHRA
14.00 – 14.15 Discussion  
14.15 – 15.15 Including tea/coffee Applying the risk assessment– use own examples or follow suggested scenarios to work through in table groups, and identify questions for clarification.  John Kerridge LILLY
15.15 – 15.55 Feedback, clarification and discussion Each table to summarise key points John Kerridge LILLY

Richard Andrews, MHRA

16.00 Close  

Numbers will be strictly limited to 50 attendees.

To book your place and pay by Credit Card: click on the green button at the top of this advert.

Confirmation of your place and VAT receipt: You will receive this by e-mail within a week of booking your place. A certificate of attendance will be provided at the meeting for your CPD records.

To contact the meeting organiser: e-mail admin@pqg.org


Tuesday, 19 March 2013:
The 16th Annual Discussion Meeting with the MHRA for QPs, QA Managers and their colleagues (open to Non Members)

Location: CCTV Smithfield, London. Click here for instructions to find it

This meeting will begin at approx 11:00 and end by 16:00

There will be an initial presentation by a Member of the MHRA Inspectorate followed by the discussion meeting and further information will be added when available.

Questions: As in previous years, questions on any aspects of GMP from the audience will be discussed openly.

We are again asking attendees to submit questions to Bookings well in advance to allow sufficient time for MHRA to review and collate responses.  Consequently, we will take questions from now until 1st February 2013.  After that questions can only be asked if there is time on the day.

The meeting is now fully booked if you want to join the waiting list for this meeting send an e-mail to Sarah.

 

To contact the meeting organiser: e-mail Bookings@pqg.org

Confirmation of your place and VAT receipt: You will receive this by e-mail within a week of booking your place.  A certificate of attendance with be provided at the meeting for your CPD records.


Tuesday, 19 March 2013:
The PQG Annual General Meeting (PQG Members only)

Location: CCTV Smithfield, London Click here for map and instructions

This meeting will begin at approx 9:30 and end by 10:45

PQG members do not need to book for this part of the meeting


Wednesday, 28 November 2012:
PQG Seminar for Trainee QPs

CCT Venues, Barbican, London

09:00 for a 09:30 start, ending at 16:20

 

This seminar is aimed at trainee qualified QPs and their sponsors.

As well as detailing the requirements and processes that are part of becoming a QP, it will provide an ideal forum for discussion, an excellent opportunity to network with other QPs and will count towards your CPD.

The days programme will include presentations on:

  • The Application Process
  • The Assessment Process and the Role of the Sponsor
  • QP Hot Topic
  • GMP & Regulatory Update

Between presentations we will work through various scenario questions to help delegates prepare for the QP viva examination.

The Pharmaceutical Quality Group will issue an attendance certificate for use in your Continuing Professional Development (CPD) programme.

PQG Members are urged to book immediately as previous meetings have been well attended and there is a limit of 25 attendees.

The cost of the meeting includes lunch (a vegetarian option is available) and tea/coffee at breaks.

 

To book your place and pay by Credit Card, click on the green button above in this advert

Contact the meeting organiser: Bookings@pqg.org

Confirmation of your place and VAT receipt: You will receive these by e-mail within a week of booking your place.

Numbers will be strictly limited to 25 attendees.

 


Thursday, 8 November 2012:
The PQG 35th Anniversary Meeting

To celebrate the 35th Anniversary of the PQG, we have organised an Anniversary Dinner on the evening of 7th November and a meeting on the 8th November at the Marriott Hotel, Waltham Abbey.

The meeting cost is as normal, but we are subsidising the cost of the dinner and hotel overnight stay for all attendees.

Location: The Marriott Hotel, Waltham Abbey Click here for map

Agenda and speakers: Click here to download

The program looks back, but is mainly intended to look to the future with challenges to attendees.

09:00 Registration/coffee

09:30 Chairman’s welcome    Phil Butson (PQG)

09:40 Reflections on a career in industry – golden nuggets of advice Gordon Munro (former Watson/MHRA/Glaxo)

10:10 Regulator viewpoint – recent history; current situation; changes to expect in next 5 years Gerald Heddell (MHRA)

10:45 A wider perspective on Quality – current developments in quality standards and what pharma might learn from other industries Simon Feary (CQI)

11:15 Tea/Coffee

11:30 An Operations Director’s view on pharma quality and QA – improving working together

12:00 ATMPs – a brave new world for pharmaceutical quality?

What ATMPs are; why we will see more of them in future; current status of regulations and guidelines; implications for pharma quality professionals Matthew Ryan (Oxford BioMedica)/Cate Sims (GSK)

12:30 – 14:00 Lunch

14:00 Pharmaceutical Quality for the 21st Century – how far have we travelled along the road envisioned by FDA and described in ICH Q8/9/10? What next? Pete Gough (NSF-DBA)

14:45 Quality thinking in other industries Dominic Parry (Inspired Pharma)

15:30 Tea/Coffee

15:45 Workshop: Moving quality thinking forwards Dominic Parry + Pete Gough + ?? facilitation

16:45 Workshop: How can PQG facilitate moving forward? Meetings, Publications… Input from attendees to development of PQG 5yr plan

17:00 Chairman’s close Phil Butson


Options available: You can book any combination of the dinner, a hotel overnight stay and the meeting. The Options are listed below.

Contact the meeting organiser on Bookings@pqg.org

Bookings are now open, so choose which Option you want and click the green button for that option

Confirmation of your place and VAT receipt: You will receive these by e-mail within a week of booking your place.


Thursday, 8 November 2012:
Option ONE (dinner, hotel and meeting)

Come to the dinner on 7th November, stay overnight at the Marriott Hotel and attend the meeting on the 8th November.  The cost includes the conference dinner including wine, your stay overnight at the hotel including breakfast and the meeting with refreshments and lunch.

The price does not include any extra charges incurred in your room, or in the bar, and you will be asked to provide a credit card to the hotel when you check in.

This option was only available through PQG until October 20th, but you may still be able to reserve a room at the hotel in your name and pay the hotel directly yourself.  Use Option TWO to come to the dinner and meeting and Option THREE for Meeting only.


Thursday, 8 November 2012:
Option TWO (dinner and meeting)

Come to the dinner on 7th November and attend the meeting on the 8th November.  The cost includes the conference dinner including wine and the meeting with refreshments and lunch, but no overnight stay at the hotel.

This option will be suitable for those living nearby, or book too late to obtain the subsidised room rate.  If you need a hotel room and are booking this option, you will need to separately reserve and pay for your own room.


Thursday, 8 November 2012:
Option THREE (Meeting only)

Attend the meeting on the 8th November.  The cost includes only the meeting with refreshments and lunch.


Tuesday, 25 September 2012:
Industrial Visit

This meeting will be held at the GSK Distribution Hub at Harlow.

Location: GSK, New Frontiers Science Park, Third Avenue, Harlow CM19 5AW


Tel: 01279 622000

During this visit you will have the opportunity to see operations relating to the packaging, labelling and distribution of investigational medicinal products (IMPs).

Interactive sessions will also be run covering some of the specific challenges of IMPs and some of the activities undertaken at the site to improve quality.

The day will start at 09.30 and finish at 16.30.  Please arrive at about 9/9.15 to allow time through Security.

The host for the day is Phil Butson, PQG Chairman.  To contact Phil: chairman@pqg.com


Thursday, 28 June 2012:
PQG Seminar for Trainee & recently Qualified QPs

The seminar is aimed at trainee & qualified QPs.

 

It will be held at Eden Biodesign Ltd in Liverpool. Location: Click here for map

 

Programme

 

08:30 Registration and coffee
09:00 Introduction and housekeeping Mick Stuart (GSK/PQG)
09.10 Biotech Facility overview Biodesign speaker
09.30 Biotech Manufacturing process Biodesign speaker
10.00 Scenario Session 1
10.45 Coffee/Tea Break
11.00 Facility tour
12.30 Lunch
13:15 Biotech Quality Assurance Biodesign speaker
14.00 Scenario Session 2 PQG
15.30 Coffee /Tea Break
15.45 QP Regulatory and current issues Mick Stuart (GSK/PQG)
16.15 Closing comments

 

 


We will also work through various scenario questions to help delegates prepare for the QP viva examination.

Click here to download the agenda for the meeting

The Pharmaceutical Quality Group will issue an attendance certificate for use in your Continuing Professional Development (CPD) programme.

Confirmation of your place and VAT receipt: You will receive these by e-mail within a week of booking your place.

Contact the meeting organiser on Bookings@pqg.org


Wednesday, 16 May 2012:
A Discussion Meeting on The Falsified Medicines Directive & EXCIPACT

Implementation of the Falsified Medicines Directive (FMD)

Implications for Control of Pharmaceutical Packaging and Excipients, including EXCIPACT Certification

Location: The Royal Pharmaceutical Society, London. Click here for map

Meeting registration: at 9.30am.

The programme for the day includes:

 

  • Introduction to FMD – including Risk Assessment & Excipient Certification  Richard Andrews, MHRA
  • IPEC proposal for Excipients Risk Assessment as required by FMD            Ian McKeown, EXCIPACT
  • Overview and implementation the EXCIPACT Certification Scheme            Allan Whiston EXCIPACT
  • A Supplier view of costs vs. benefits for EXCIPACT                                   Frithjof Holtz  MERCK
  • Pharma view including acceptance of certificates                                       Steve Moss  PQG/GSK
  • Panel questions of Morning Speakers
  • Lunch
  • FMD – implications for medicinal products packaging                                   Richard Andrews, MHRA
  • How the Pharmaceutical industry proposes to address the packaging implications of FMD
    Grant Courtney EFPIA/GSK
  • Panel questions of Afternoon Speakers

Chairman: Norman Randall.

 

Confirmation of your place and VAT receipt: You will receive these by e-mail within a week of booking your place.

 

 

 

To download the Agenda Click here

 

 

 

 

 

 

 

 

 

 

 

 

 

Contact the meeting organiser on Bookings@pqg.org

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 


Tuesday, 20 March 2012:
The 15th Annual Discussion Meeting with the MHRA for QPs, QA Managers and their colleagues (Open to Non Members)

Location: CCTV Smithfield, London. Click here for instructions to find it

This meeting will begin at approx 11:00 and end by 16:00

There will be an initial presentation by Ian Jackson – Operations Manager of the MHRA Inspectorate followed by the discussion meeting.

Richard Funnel – Senior Inspector & Daniel Davies – Inspector will also be present

 

As in previous years, questions on any aspects of GMP from the audience will be discussed openly.

 

The time for submitting questions to the Inspectors for detailed answers is over, but questions may still be sent by attendees to Neil Wayman at bookings@pqg.org for answering at the meeting, if there is time.

The meeting is now fully booked


Monday, 19 March 2012:
Annual General Meeting

Type out your event details here. This will appear on the website under the event’s date.


Wednesday, 25 January 2012:
EXCiPACT Launch event

This meeting is being organised by Excipact and PQG have been heavily involved in this project

Location: Catalonia Berna Hotel, Barcelona

Time: 2.00pm – 6.00pm

The preliminary programme is attached Click here to view it.

A short background paper on EXCiPACTTM is also attached here.

To Book:
As the EXCiPACTTM Launch event is to be followed by IPEC Europe’s 20th Anniversary seminar and gala dinner on 26th January and their AGM on 27th January, they have kindly agreed that those who are interested only in the EXCiPACTTM Launch event can use their registration system for this purpose – see http://www.event-solutions.fr/ipec-europe/. Whilst there is no charge for participation only in the EXCiPACTTM Launch event, you will be responsible for your own travel and hotel costs. Please note that you can only use this form to book your hotel if you also are attending the IPEC Europe events. You will receive an automatic email confirming your registration.

Should you have any questions, please direct them to info@excipact.org

The EXCiPACT Launch Team can also be contacted using info@excipact.org


Monday, 2 January 2012:
PS9000 order for Jones

Type out your event details here. This will appear on the website under the event’s date.


Thursday, 17 November 2011:
PQG Seminar for Trainee & Recently Qualified QPs

Location: Colorcon, Dartford

The Pharmaceutical Quality Group’s 2nd conference in 2011 for Trainee and Recently Qualified QPs.

The day will include presentations aimed at the QP from experienced members of the industry, a QP Scenario work shop session as well as a tour of the Colorcon Facility.

Please Note: The number of attendees is restricted to 25, so book early to be sure of a place

There are places available to book as long as there is a GREEN button showing that says “Book Place”

If there is a RED button that says “Fully Booked“, then there are NO places left 

To contact the meeting organiser, Click here 


Wednesday, 14 September 2011:
Launch of the PQG PS 9000:2011 Pharmaceutical Packaging Materials

Location: Royal Pharmaceutical Society of Great Britain, Lambeth, London

09.30 for a 10.00 start, ending at 16.00 (see Agenda below)

A Revised Standard for Pharmaceutical Packaging Materials Incorporating Good Manufacturing Practice (GMP)

The meeting will be chaired by Norman Randall and brings together a team of high profile speakers with a wealth of experience from the Pharmaceutical Industry, their Suppliers, Regulators (Mark Birse from the MHRA) and Industry bodies (IPAC-RS). The speakers will be sharing the updated requirements and guidance from the PS 9000:2011 Standard and its applicability to suppliers and the Pharmaceutical industry in ensuring appropriate Good Manufacturing Practice within the supply chain for packaging material.

For further information & Agenda, Click Here

To contact the meeting organiser, Click here

09:30

Registration and refreshments

 

10:00

Chairman’s introduction

 Norman Randall

Consultant & PQG Webmaster

10:05

Introduction

  • PQG / Partners / Projects
  • Introduction to PS 9000 certification scheme & transition arrangements
  • Training

Justin Ahern

QP/ QA Manager, Teva UK Limited

10:30

PS 9000:2011 Standard

  • Driver for revision (ISO 15378 gaps & technology)
  • Project team + IPAC-RS
  • Benefits

David Abraham

Group Business Improvement Manager, TAG: Worldwide

11:00

PS 9000:2011 – what has changed?

  • Content – key changes
  • Format

Colin McEnaney

Supplier Quality Manager,

Sanofi – aventis

11:40

Regulatory perspective – MHRA

  • Importance of standards for suppliers of primary and secondary pharmaceutical packaging materials
  • Potential problems with supply of packaging materials and the impact on safety & efficacy of medicines
  • Regulatory developments in this area
  • Value of the revised PS 9000 which communicates the appropriate levels of GMP at the suppliers as expected by the pharmaceutical industry.

Mark Birse

Group Manager, Inspections (GMP/GDP), Medicines and Healthcare products Regulatory Agency (MHRA)

12:15

Questions

 

12:30

LUNCH

 

13:45

A QMS for Pharmaceutical Origination

  • A structured approach to Pharmaceutical Origination
  • Benefits of using PS 9000 in an Artwork Studio

Suzanne Ivory

QA Manager, Perigord Group

14:10

Primary and Complex Components

  • Use for Primary Packaging Materials
  • Incorporation of IPAC-RS / complex requirements into PS 9000:2011
  • Benefits to suppliers and the Pharmaceutical industry

Barbara Falco

Consultant / IPAC-RS

14:35

Supplier perspective – Secondary packaging

  • Benefits to suppliers and the Pharmaceutical Industry
  • Benefits of dual certification to PS 9000 and ISO 15378

Arne Hoffmann Christiansen

Quality Systems Manager,

Strålfors Identification Solutions

15:00

Pharmaceutical Industry Position

  • Benefits in consistency, reduced audits, short-listing suppliers
  • Fit with other schemes

Ian Williams

Associate Director – Quality, Wockhardt

15:25

Questions

 

15:45

Refreshments and close

 

 


Thursday, 28 July 2011:
Industrial visit to Aptuit, Oxford

Sorry, but this meeting is already FULLY BOOKED; the waiting list is also full.

Location: Aptuit, Abbingdon Click here for map

111 Milton Park, Abingdon, Oxfordshire, OX14 4RZ

Upon arrival at Aptuit, report to Reception & you will be escorted to the meeting room

The day will include presentations about the facility and a facility tour:

10.00 Arrival tea/coffee

10.15 Opening presentation – Aptuit & the OXF site (API manufacturing) – what we do & how we do it

10.45 Main presentation – Multipurpose API manufacture in a high potent facility

11.45 Buffet Lunch

12.30 Tour of facility

13.15 Q&A session

14.00 Close

The visit was restricted to a maximum of 15 people and it is now fully booked

For further information Contact meeting organiser, Jane.


Thursday, 16 June 2011:
Analytical methods to combat the Counterfeiting of Medicines

Location: GSK Laboratories, Stevenage

This is a JPAG Meeting

 


Wednesday, 15 June 2011:
PQG Seminar for Trainee & Recently Qualified QPs

Location: CCT Venues, Smithfield, London Click for instructions

09:00 for a 09:30 start, ending at 17:00

The QP seminar is ideal for Trainee QPs and their Sponsors who want to learn more about QP training process.

This seminar is aimed at trainee qualified QPs. As well as detailing the requirements and processes that are part of becoming a QP, it will provide an ideal forum for discussion, an excellent opportunity to network with other QPs and will count towards your CPD.

The days programme will include presentations on:

  • The Application Process
  • The Assessment Process and the Role of the Sponsor
  • QP Hot Topic
  • GMP & Regulatory Update

Between presentations we will work through various scenario questions to help delegates prepare for the QP viva examination.

The Pharmaceutical Quality Group will issue an attendance certificate for use in your Continuing Professional Development (CPD) programme.

PQG Members are urged to book immediately as previous meetings have been well attended and there is a limit of 40 attendees.

The cost includes lunch (a vegetarian option is available) and tea/ coffee at breaks.

VAT receipts will be issued at the meeting.

Numbers will be strictly limited to 40 attendees.

For further information Contact meeting organiser Mick.

The meeting agenda is in the attachment below

Attachments:


Tuesday, 17 May 2011:
Joint meeting with BARQA on Investigational Medicinal Products

Location: CCT Venues, Smithfield, London Click for instructions

There will be presentations from industry experts on the regulations controlling IMPs with particular focus on the QP role in this area.

10:00-10:30 Introduction & Overview
10:30-11:15 Clinical Trials Directive – Challenges and process overview
11:15-11:45 Tea Break
11:45-12:30 Annex 13 – Interpretation, vagaries and application
12:30-13:30 Lunch
13:30-14:30 QP Transferable skills – moving from commercial to IMP
14:30-14.45 Tea Break
14.45-16:15 Interactive IMP labelling workshop – blinding and labelling
16:15-16:30 Wrap up & Close

Cost of the meeting

£180.00 (£150.00 + £30.00 VAT) for PQG Members
£225.00 (£187.50 + £37.50 VAT) for non-members


Tuesday, 8 March 2011:
The PQG Annual General Meeting (PQG Members only)

Location: CCTV Smithfield, London Click here for map and instructions

This meeting will begin at approx 9:30 and end by 10:45

PQG members do not need to book for this part of the meeting


Tuesday, 8 March 2011:
The 14th annual discussion meeting with the MHRA for QPs, QA Managers and their colleagues (Open to Non Members)

Location: CCTV Smithfield, London Click here for map and instructions

This meeting will begin at approx 11:00 and end by 16:00

There will be an initial presentation entitled “Recent issues – Compliance with MA“, followed by an open discussion meeting with Ian Jackson MHRA GMP Operations Manager & Senior Inspector, Malcolm Olver and Richard Funnell of the MHRA Inspection & Standards Division.

Questions on any aspects of GMP from the audience will be discussed openly.  Attendees are invited to submit questions in advance so that the MHRA Inspector can research the questions, but other questions may be asked at the meeting if time is available.

Click here to download the meeting notice

The meeting was limited to 50 attendees and was fully booked


Thursday, 11 November 2010:
PQG Seminar for Trainee & Recently Qualified QPs

Location: Eisai, Hatfield

PQG Seminar for Trainee & Recently Qualified QPs

The Pharmaceutical Quality Group’s 2nd conference in 2010 for Trainee and Recently Qualified QPs will be held on the 11th November at Eisai Manufacturing Limited in Hatfield, Herts.

The day will include presentations aimed at the QP from experienced members of the industry, a QP Scenario work shop session as well as a tour of the Solid Dose Manufacturing and Packing facilities at Eisai. An opportunity not be to missed.


Wednesday, 1 September 2010:
Quality Risk Management

Location: CCTV – Smithfield, London

Quality Risk Management

The day will include input from both the Regulators and from Industry on how the implementation of Risk Management principles is progressing – including what is working and what is not working. The day will also include workshops to risk assess real issues.


Wednesday, 19 May 2010:
PQG Seminar for Trainee & Recently Qualified QPs

Location CCTV, Smithfield, LondonClick here for map

PQG Seminar for Trainee & Recently Qualified QPs

The QP seminar is ideal for Trainee QPs and their Sponsors who want to learn more about QP training process.
The day will include presentations from the Professional Bodies about the Application Process, the Joint Panel of Assessors on the QP Viva, a newly Qualified QP on their experiences and a presentation from an industry expert on “What’s New in GMP”.
The event also includes a QP Scenario workshop so you can get to practice those tricky Viva questions!!
It is also an excellent opportunity to meet other Trainee and qualified QPs and build up your invaluable QP network.


Thursday, 25 March 2010:
The PQG Annual General Meeting (PQG Members only)

Location: CCTV – Barbican, London Click here for map

The PQG Annual General Meeting (PQG Members only)
This meeting will begin at approx 9:30 and end by 10:45

PQG members do not need to book for this part of the meeting

Attachments:


Thursday, 25 March 2010:
The annual discussion meeting with the MHRA for QPs, QA Managers and their colleagues (Open to Non Members)

Location: CCTV – Barbican, London Click here for map

The annual discussion meeting with the MHRA for QPs, QA Managers and their colleagues (Open to Non Members)

A presentation on:
The presence of Counterfeits in the UK market
by Nimo Ahmed, Head of Intelligence in the MHRA Enforcement Group

Followed by:

An open discussion meeting with Ian Jackson, MHRA GMP Operations Manager & Senior Inspector, Inspection & Standards Division.

Questions on any aspects of GMP from the audience will be discussed openly. Attendees are invited to submit questions in advance so that the MHRA Inspector can research the questions, but other questions may be asked at the meeting if time is available.

The questions and answers for thus discussion are available to MEMBERS ONLY in the Members only area

Click here to download the meeting agenda

This meeting was fully subscribed .

Attachments:


Tuesday, 23 February 2010:
Launch of PQG Supply Chain Risk Management Guide at RPSGB, London

Location: The Royal Pharmaceutical Society of GB

Launch of PQG Supply Chain Risk Management Guide at RPSGB, London

Hear the latest developments on how to apply risk management throughout the Supply Chain. This event brings together a team of high profile speakers with a wealth of experience from the pharmaceutical and medical device industries and their suppliers. MHRA, ICH Q9, IPEC, APIC and Rx-360 will all be represented.

Make sure you don’t miss this important opportunity for quality, technical, manufacturing, R&D and procurement personnel from pharmaceutical and medical device industries and their suppliers/contractors.
Click here for full conference details

Attachments:


Wednesday, 30 September 2009:
GlaxoSmithKline

Wednesday 30th SeptemberLocation: GlaxoSmithKline, Ware, HertfordshireTHIS LINK IS BROKEN

Industrial visit to the tablet and respiratory manufacturing/packaging facility of GSK at Ware

This will be a visit to the GlaxoSmithKline Ware facility to include a tour of the tablet manufacturing and respiratories manufacturing areas from 10:30 am to 4pm.

Click here to see and download the program


Sunday, 31 May 2009:
PQG Seminar for Trainee & Recently Qualified QPs

Location CCTV, Barbican, London. (Click for location map)

The QP seminar is aimed at trainee QPs and their Sponsors.  It will provide a forum for discussion, as well as contact with other Qualified Persons and relevant extra training.

Click here to download details of the meeting.
Click here to download the meeting agenda.


Thursday, 30 April 2009:
Launch meeting for the joint PQG and Pharmig Guide

Thursday, April 30th

Location CCTV, Smithfield, London. (Click for location map)

The PQG and Pharmig published a joint monograph relating to Microbiological Control for
Non-sterile Pharmaceuticals at the end of 2008.

There will be a key note presentation from Gerald Heddell, Director of the Inspection, Enforcement and Standards Division at MHRA.
The co-editors and some of the authors will provide an overview of the guidance within the monograph and its application; there will be the opportunity for questions and answers.


Monday, 23 March 2009:
The PQG AGM (PQG Members only) and The annual discussion meeting with the MHRA for QPs, QA Managers and their colleagues.

Monday March 23rdThe PQG AGM (PQG Members only) and

Location CCTV, Smithfield, London. (Click for location map)

This is year we have MHRA Expert Inspector, Bronwyn Phillips, coming who will give a presentation on the “The Supply Chain and GMP.”

The presentation will be followed by an open discussion meeting. Questions on any aspects of GMP from the audience will be discussed openly. Attendees are invited to submit questions in advance so that the Inspector can research the questions, but other questions can be asked at the meeting subject to time constraints.

The agenda for the day is:

09:00 Arrival -Tea and coffee available
09.30  PQG AGM – all members are welcome Chaired by Ashley McCraight
Members Click here for agenda items
10:45   Tea and coffee available
11:00   Introduction to the MHRA discussion meeting Chaired by Norman Randall
11:10    Presentation �The Supply Chain and related GMP�. Bronwyn Phillips
11:40   Open discussion meeting   Norman Randall
13:00   Lunch with Poster Session showing PQG activities
14:00   Open discussion meeting – continuation
15:30   Tea and coffee available
15:45   Open discussion meeting – continuation
16:30   Meeting closes

This meeting was oversubscribed.


Wednesday, 4 February 2009:
Company Visit to Genzyme

Date: Wednesday 4th February 2009Company Visit to Genzyme

Location Haverhill

The Meeting starts at 10:00 and will finish around 15:00

The programme for the day includes:

  • An introduction to Genzyme
  • A presentation on Applications of Process Analytical Technology in Chemical Development and beyond
  • A tour of the Genzyme API Manufacturing facilities, the Quality Control Laboratories and labelling of Therapeutic products

This meeting was FULLY BOOKED


Wednesday, 19 November 2008:
Development of the PS 9000/9100 Supplier Certification scheme

Date: Wednesday November 19thDiscussion Forum
Development of the PS 9000/9100 Supplier Certification scheme
The topic of GMP standards for suppliers is developing quite rapidly and the PQG has been actively engaged with this process in conjunction with the IPAC-RS, IPEC & ISO organisations. We recently shared our proposals for updating PS 9000 & PS 9100 with representatives of the Certification Bodies (CB), who are active in supporting the PQG scheme and their reaction was constructive. This meeting is designed to update you on these proposals, the CB reaction to them and take account of the views of suppliers especially and other members who attend the workshop.The meeting will run from 10:30 to about 15:00. Lunch and refreshments are included in the fee of 50+VAT (58.75).

Agenda:
10:30 Introduction
10:40 Open discussion and Feedback on current PS scheme
11:15 The proposals for updating the PS scheme & feedback from certification bodies
11:45 Reactions on PS 9000. [Breakout discussion]
12.30 Lunch
13.15 Update on current PQG projects
13.30 Reactions on PS 9004. [Breakout discussion]
14.00 Reactions on PS Supplier Certification & Auditor Accreditation schemes [Breakout discussion]
14.45 Summary and next steps
15.00 Close + Tea

Location: CQI Headquarters,
12 Grosvenor Crescent, London
. Click here for location map


Wednesday, 12 November 2008:
PQG Seminar for Trainee & Recently Qualified QPs

Date: Wednesday November 12th

PQG Seminar for Trainee & Recently Qualified QPs

Location: Loughborough at the Astra Zeneca R&D facility

Please click here to download a meeting notice.


Monday, 29 September 2008:
A Joint BARQA/PQG Discussion Forum

Date September 29th

A Joint BARQA/PQG Discussion ForumEngineering Hot Topics

Location: Madingley Hall, Cambridge

The bookings are all being arranged by BARQA and Members of both groups are eligible for discounted rates.
PQG Members should download a form, complete it and send to BARQA with payment.

Programme:
09.30 Registration and coffee
09.45 Introduction, Dave Sanson, Genzyme Ltd
09.50 Calibration and Risk Management, Steve Squirrell, MedImmune
11.30 Change Control Peter Thomas
12.30 Lunch
13.15 Change Control continued
13.45 Deviation Management, Vic Edy, Newland GxP Consultancy
15.15 Coffee
15.30 Close of day


Wednesday, 28 May 2008:
Seminar for Trainee QPs and their Supervisors

Location CCTV, Smithfield, LondonClick here for location map

This seminar is aimed at trainee and recently qualified QPs and their Sponsors.  It will provide a forum for discussion, as well as contact with other Qualified Persons and relevant extra training.

The programme includes presentations detailing:

  • QP Application Process – Jane McLauchlin (RSC) Sarah Durant (IoB)
  • Role of the QP Assessor – Alex Hall (Roche)
  • My Experiences of the Viva Process – Anthony Pinney (Cardinal Health)
  • A Guide For Sponsors – What the Assessors Expect – Alex Hall (Roche)
  • QP Viva Scenario Workshops Session – Samantha Clack (Lilly/Eisai)
  • GMP & Regulatory Update – Peter Gough (DBA)

Please click here to download a meeting notice and costs for you to keep.


Thursday, 13 March 2008:
PQG Annual General Meeting

Location CCTV, Smithfield, LondonClick here for location map

This meeting will preceed the Annual QP Discussion Meeting.

It will start at about 09:30 and finish by 10:45. PQG Members may download AGM information from this page link before the meeting.


Thursday, 13 March 2008:
Discussion meeting with the MHRA for QPs, QA Managers and their colleagues

Location CCTV, Smithfield, London. Click here for location map

This meeting, which starts at 11:00am follows the AGM.

Last year it was fully subscribed. It is normally a lively and open discussion of attendees questions with an MHRA Inspector.
This is year we have Senior Inspector, Ian Thrussell (changed recently from Ian Rees), who will also give a short presentation on the findings of the consultation on MLX 345 (Risk Based Inspections).

Click here to download the program for the day.

This meeting was fully subscribed.


Tuesday, 27 November 2007:
Into the future also the 30th Anniversary of the PQG

Tuesday, November 27th (with optional dinner on Nov 26th)

“Into the future” also the 30th Anniversary of the PQG

Location: The Marriott Hotel, Waltham Abbey (M25 Junction 26).

This meeting covers the future of the industry by well known speakers, offering a valuable learning/development opportunity with excellent networking opportunities with colleagues and the MHRA.
The programme includes:

  • A retrospective view of how industry has performed by Graham Davison
  • An insight into future legislation & its implications by Peter Gough
  • QP Training and it’s evolution by Sam Clack and Nigel Hodges
  • The MHRA’s experience of manufacture outside the EU by Ian Thrussell of the MHRA
  • Discussion on implications for QPs and industry generally.

 


Tuesday, 6 November 2007:
Seminar for trainee and recently qualified QPs

Seminar for trainee and recently qualified QPs

Location CCTV, Smithfield, London. Click here for location map

The programme includes presentations by:

  • An applicant who has recently completed the QP Viva
  • QP Officers from the Professional Bodies
  • A QP assessor

Between presentations we will work through various scenario questions to help delegates prepare for the QP viva examination.
A brief update on GMP & Regulatory issues will also be provided.

The Pharmaceutical Quality Group will issue a certificate for use in your Continuing Professional Development (CPD) programme.

Attachments:


Wednesday, 31 October 2007:
Partners Project Initiation

Partners Project Initiation

Location CQI/IQA Headquarters, LondonClick here for location mapTHIS LINK IS BROKEN

There is no charge for the meeting. For an application formClick here

Attachments:


Tuesday, 23 October 2007:
Industrial Visit Location Novozymes Delta and Biocity, Nottingham.

Industrial Visit Location Novozymes Delta and Biocity, Nottingham.

This event involves a visit to Novozymes Delta in the morning followed by Biocity in the afternoon.
These two facilities are within half mile of each other. NG2 3ED & NG1 1GF
Novozymes Delta manufacture animal free Human Albumin by a recombinant process and won a Queens Award for Enterprise in 2005.
Biocity offers a range of services to the pharmaceutical industry.


Monday, 24 September 2007:
IPAC-RS Workshop on Extractables and GMP for Components of Inhalation & Nasal Drug Products.

IPAC-RS Workshop on Extractables and GMP for Components of Inhalation & Nasal Drug Products.

This event is being organised by IPAC-RS who worked with PQG to produce the GMP guideline for Orally inhaled and Nasal Drug products from PQGs PS9000

The programme is available here.


Tuesday, 18 September 2007:
Super Sig meeting – The Future of the CQI .

Super Sig meeting – The Future of the CQI .

This event is being organised by the CQI special Interest Groups.
Details are available on the Home page of the CQI web site


Wednesday, 4 July 2007:
Regulatory Update Meeting.

Regulatory Update Meeting.

Location CCTV, Smithfield, London.Click here for location map

Regulations/Legislation – How to keep up to date!
What is current? Are you as up to date as you think you are?

Licence renewal – CTD preparation – Quality Summary requirement Impact of keeping up to date on Pharmaceutical business
Open discussion and debate of current topics of interest
.

This meeting was aimed at those wanting to improve methods for keeping upto date with the ever changing regulatory environment. Invited speakers provided their views on how this may be achieved. A session will be devoted to the Annex 1 update. Interactive sessions provided a forum for current topics of interest in the regulatory arena, the opportunity for open discussion and networking.

Attachments:


Tuesday, 5 June 2007:
Seminar for trainee and recently qualified QPs

Seminar for trainee and recently qualified QPs

Location:
Institute of Pharmaceutical Innovation at the University of Bradford

Click here to see the Brighton University QP prize winner for 2006 awarded her prize.

Attachments:


Thursday, 19 April 2007:
Risk Assessment and Management

Risk Assessment and Management.

Location CCTV, Barbican, London Click here for location map

This meeting included presentations on how risk assessment and
management tools have been utilised in various pharmaceutical situations, including the development of an audit programme, the manufacture of excipients, the validation of computerised systems and reducing the risk of human errors.

Attachments:


Tuesday, 27 March 2007:
10th Annual QP Discussion meeting with MHRA Inspector (Ian Rees)

10th Annual QP Discussion meeting with MHRA Inspector (Ian Rees).


Location CCTV, Smithfield, London. Click here for location map


This fully subscribed meeting started with a presentation by Ian Rees on Regulating the Regulator, followed by a lively and open discussion of attendees questions with the MHRA Inspector.

Attachments:


Thursday, 17 March 2005:
Good Quality Control Laboratory Practice

A lively Morning Session: discussing the way forward and committee structure

  • Chairman’s report with updates on new web site and plans for the group
  • Filling of vacant Committee positions
  • Discussion on changes to ways of working
  • The opportunity to bring up any other business.

Afternoon Session
An excellent meeting on Good Quality Control Laboratory Practice including introduction to the new monograph published today. An Overview of the new GCLP monograph, Paul Stockbridge was followed by a technical talk; New Perspectives on Validation, from John Lees, Lees Gilbert International Limited. John Taylor then enlightened the audience of some 36 members on the current MHRA views and findings from laboratories.

An interesting discussion period brought the excellent day to a close.

Download directions to IOD Directions to the IOD, PDF (81Kb)

Attachments:


Thursday, 30 September 2004:
The Launch of PS 9004

The Launch of PS 9004

The four launch events proved to be very successful with a lot of interest being shown in this important new document.

Full details are still downloadable in PDF format:


Download PS 9004 Launch Flyer

PS 9004 launch flyer PDF (239Kb)

Attachments:


Wednesday, 15 September 2004:
Meeting on Risk Managment

Meeting on Risk Managment

A meeting for members of all the IQA SIGs took place on the 15th September 2004 on the subject of Risk Management. Since the SIGs cover areas such as Human Factors, Health & Social care, Devices and Engineering this was a well attended and interesting meeting that involved both the presentation of papers and workshops.

2004 MDQG Workshop on Software Validation


Monday, 13 September 2004:
Second QP discussion meeting for 2004

Our second QP discussion meeting for 2004 was held on the 13th September at the IOD (PDF 81Kb), Pall Mall, London.

This QP meeting, as always, proved to be very successful and quite well attended although numbers did not reflect the apparent demand that we get from members. So where was everybody? You missed a very thought provoking day!

John Dolman talking about cGMP and the QP
John Dolman talking about cGMP and the QP

A lively discussion followed John’s excellent presentation and then the meeting split into groups to discuss a recall scenario.

Norman Randall surveys a perplexed group trying to untangle the scenario details!
Norman Randall surveys a perplexed group trying to untangle the scenario details!

Attachments:


Wednesday, 31 March 2004:
Trainee QP meeting at Aventis Pharma, Holmes Chapel

A very successful meeting attended by some 50 trainee QPs. Representatives of all three professional bodies gave talks on various aspects of the trainee qualification and viva processes. A newly qualified QP also gave his insight into the viva; the pitfalls and highlights of what, for some, may seem a daunting prospect but taken with good preparation and an open mind, need not prove too stressful.

Group sessions also looked at various viva questions with advice and encouragement being provided by the speakers and members of the PQG.

Included in the day was a tour of the site.

All agreed that this, as always with these events, was a most useful, pleasant and informative day.

Thanks must go to all the Aventis staff for organising the day in such a splendid manner, to Paul Stockbridge for his help in sorting out the venue and especially to Alex Hall and her team, including the representatives of the professional bodies, for getting the whole thing off the ground and making the day such a success.


Monday, 1 March 2004:
AGM and QP – MHRA meeting

This years AGM was held at the Institute of Directors, 116 Pall Mall, London.

The main points that arose were:

  • The resignation from the committee of Peter Gough, Ian Richardson and Richard Packer.
  • The unopposed election of Diane Morris, Glen Chapman and John Lees to the committee.

A brief but informative overview of the new PS9004 – Guide to the GMP Requirements of PS9000:2000 was given by Roy Evans.

Download PS 9004 Launch Flyer PS 9004 launch flyer PDF (239Kb)

Roy Evans talking about PS9004
Roy Evans talking about PS9004

At the conclusion of the AGM, David Mogg took over as Chairman from Norman Randall who had served his three years and steps down to be Vice Chairman.

David Mogg (incoming Chairman) presents Norman Randall (outgoing Chairman) with a claret jug and glasses and a bottle of Bonderra Zinfandel.
David Mogg (incoming Chairman) presents Norman Randall (outgoing Chairman) with a claret jug and glasses and a bottle of Bonderra Zinfandel.

The AGM was followed by a QP – MHRA discussion meeting.

Download QP Questions for March 2004 QP Questions March 2004 PDF (65Kb)

Bernadette Sinclair Jenkins and Tony Trill represented the MHRA in what has traditionally been seen as a most important event of great relevance to practicing QPs. This years meeting proved no exception.

Norman Randall with Bernadette Sinclair Jenkins and Tony Trill from the MHRA.
Norman Randall with Bernadette Sinclair Jenkins and Tony Trill from the MHRA.

A lively discussion on many current topics of concern filled the day. The MHRA representatives responded in an open and detailed debate that helped many of the 45 attendees from across the industry, address personal and professional issues. This year, questions centred, as may have been expected, upon Clinical Trials and IMPs. General GMP and QP matters were less to the fore but were nevertheless of much interest to all.

On the domestic side, all seemed to agree that the new venue was easy to get to, lunch was very good and the room was just right. The only issue appeared to be that microphones were not available: a small but important point that will be addressed at the next meeting.

Attachments:


Sunday, 18 May 2003:
GMP Course

This successful PQG course was once again held in York (Moat House Hotel), England.


Monday, 14 April 2003:
Our Annual Discussion Meeting For QPs

IQA, 12 Grosvenor Crescent, London

The annual discussion meeting for Qualified Persons was held and was it again supported by the MHRA with Bernadette Sinclair-Jenkins attending.

This meeting enabled QPs to meet their peer group and discuss mutual problems and issues. The discussion was very lively, and covered memebers questions on subjects including the new regulations, GMP, Risk, QP decisions and Clinical trials.

During the meeting, the PQG QP prize for 2002 was presented to the bext student from the Brighton University QP course. The chairman presented Lynne Butcher with a cheque.


Thursday, 6 March 2003:
AGM

RPSGB, 1, Lambeth High Street, London

The AGM topic was RISK; following the announcement that the FDA had become interested in the subject.

Attendees were treated to four interesting lectures on how other industries recognise the need to address risk in their own work.

Guest Speakers (from Left to right):Paul Stanton {NHS Clinical Governance Support Team}; Margaret Dangoor {Executive Director of ALARM}; Alison Carnel {Unilever}; Edward Smerdon {Reynolds Porter Chamberlain}
Guest Speakers (from Left to right):Paul Stanton {NHS Clinical Governance Support Team}; Margaret Dangoor {Executive Director of ALARM}; Alison Carnel {Unilever}; Edward Smerdon {Reynolds Porter Chamberlain}

This gave members the opportunity to learn form experts outside the normal sphere of PQG interests and they will now be more prepared to take these learning points into their own work.

Also at the AGM

Graham Davison retired after 17 years as Treasurer, for which the group was very appreciative. He was made our second Life Member and presented with a portable CD player by the chairman as a �thank-you� for his long service.

Graham Davison retired after 17 years as Treasurer


Tuesday, 28 January 2003:
PQG/PharMIG joint meeting

Microbiological Monitoring & Controls for Non-sterile Manufacturing
RPSGB, 1, Lambeth High Street, London.


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Attachments: