Meetings archive 2008

March 2008

Thursday March 13th

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.

March 2008

Thursday March 13th

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.

Bookings are now closed for this meeting.

May 2008

Wednesday May 28th -

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.

September 2008

Date September 29th

A Joint BARQA/PQG Discussion Forum

Engineering 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

Fees: £90 for BARQA and PQG members
         £112 for non‐members
Fees include VAT, buffet lunch and refreshments
Places are limited so please book early

Click here to download details and Application form

November 2008

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 and costs for you to keep.

November 2008

Date: Wednesday November 19th

Discussion 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