Events
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:
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- Introduction to FMD - including Risk Assessment & Excipient Certification  Richard Andrews, MHRA
- IPEC proposal for Excipients Risk Assessment as required by FMDÂ Â Â Â Â Â Â Â Â Â Â 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.
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Confirmation of your place and VAT receipt: You will receive these by e-mail within a week of booking your place.
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To download the Agenda Click here
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Contact the meeting organiser on Bookings@pqg.org
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Tuesday, 20 March 2012:
PQG Annual General Meeting
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
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
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As in previous years, questions on any aspects of GMP from the audience will be discussed openly.
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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
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
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.Â
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 leftÂ
To contact the meeting organiser, Click hereÂ
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 | Â |
10:00 | Chairman’s introduction |  Norman Randall Consultant & PQG Webmaster |
10:05 | Introduction
| Justin Ahern QP/ QA Manager, Teva UK Limited |
10:30 | PS 9000:2011 Standard
| David Abraham Group Business Improvement Manager, TAG: Worldwide |
11:00 | PS 9000:2011 – what has changed?
| Colin McEnaney Supplier Quality Manager, Sanofi - aventis |
11:40 | Regulatory perspective - MHRA
| Mark Birse Group Manager, Inspections (GMP/GDP), Medicines and Healthcare products Regulatory Agency (MHRA) |
12:15 | Questions | Â |
12:30 | LUNCH | Â |
13:45 | A QMS for Pharmaceutical Origination
| Suzanne Ivory QA Manager, Perigord Group |
14:10 | Primary and Complex Components
| Barbara Falco Consultant / IPAC-RS |
14:35 | Supplier perspective - Secondary packaging
| Arne Hoffmann Christiansen Quality Systems Manager, Strålfors Identification Solutions |
15:00 | Pharmaceutical Industry Position
| Ian Williams Associate Director - Quality, Wockhardt |
15:25 | Questions | Â |
15:45 | Refreshments and close | Â |
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Thursday, 28 July 2011:
Industrial visit to Aptuit, Oxford
Sorry, but this meeting is already FULLY BOOKED;Â 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
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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. Â 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, London. Click 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 AGMÂ (PQG Members only)Â 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
10:45Â Â Tea and coffee available
11:00Â Â 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
13:00Â Â Lunch with Poster Session showing PQG activities
14:00  Open discussion meeting – continuation
15:30 Â Tea and coffee available
15:45  Open discussion meeting – continuation
16:30Â Â 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 ForumDevelopment of the PS 9000/9100 Supplier Certification schemeThe 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:Â 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, London. Click 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, London. Click 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.
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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, London. Click here for location mapTHIS LINK IS BROKEN
There is no charge for the meeting. For an application form. Click 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 PQG’s 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.
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:
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
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!
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.
PS 9004 launch flyer PDF (239Kb)
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.
The AGM was followed by a QP – MHRA discussion meeting.
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.
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.
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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}
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.
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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