Contract Good Manufacturing Practice (GMP) Quality Control (QC) Labs Symposium (fully booked)

10 September 2008
MHRA Market Towers Offices, London

This event is now fully booked.
If you wish to be added to the waiting list and kept informed of future events on this topic please send an email to MHRA conferences (mhraconferences@mhra.gsi.gov.uk) with 'GMP QC Labs waiting list' in the subject line and your contact details in the body of the email.

In April 2008 the MHRA presented an extremely popular GMP QC Labs Symposium. Comments from delegates who attended were:

“All presentations extremely valuable. Very enjoyable”

“Very useful to have the Q&A sessions and also the chance to talk informally with inspectors”

“MHRA inspectors’ tips about what they expect to see versus what the often see was very useful”

Building on this success, the MHRA’s 2nd Contract GMP QC Labs Symposium on 10 September 2008 will explain the inspection process for contract GMP QC laboratories and help you to understand the implications for your organisation.

Since 2005 the MHRA has been conducting a formal programme for inspecting independent contract GMP Quality Control testing laboratories against EU GMP guidelines. The testing is a fundamental role in the production process for medicinal products. These independent QC laboratories must be named on manufacturer’s licences (marketed products) or authorisations (Investigational Medicinal Products) irrespective of the quantity or frequency of testing.

This event will focus on providing both the QC laboratory and Licence Holders with an opportunity to meet MHRA Inspectors and gain a greater insight into the current inspection programme.

Presentations will be given which outline the key issues with quality systems, highlight the common deficiencies and describe the MHRA expectations. Guidance will be given on method validation and microbiology testing issues and expectations.

By attending this seminar you will be able to:

• Gain guidance on the inspection process for contract GMP QC laboratories
• Obtain information on the licensing process for naming of contract GMP QC laboratories
• Receive guidance on the application of EU GMP to contract GMP QC laboratories
• Highlight key quality critical areas e.g technical agreements
• Investigate commonly seen GMP deficiencies
• Discover an overview of the expectations for contract QC testing laboratories and the responsibilities of both contract giver and contract acceptor

This event qualifies for 4.75 CPD points.

 
Timings of seminar:
The conference begins at 10:00am (registration from 9:30am) and finishes at 4:30pm.

 
Venue:
The seminar will be held at MHRA Head Office in London. The full address is: Market Towers, 1 Nine Elms Lane, London SW8 5NQ. Map and directions can be downloaded from our website (82Kb).

 
This event will be of interest to:

• All people working for independent Quality Control testing laboratories contracted to conduct release testing of medicinal products, intermediates or active pharmaceutical ingredients.
• All individuals within the Pharmaceutical Industry responsible for contracting out tests related to medicinal products (including intermediates and active pharmaceutical ingredients) and their subsequent assessment as fit for purpose.

 
Conference attendance:
Early bird industry fee: £250 + VAT (Register on or before 31 July 2008)
Standard industry fee: £300 + VAT (Register on or after 1 August 2008)

 
The conference fee includes:

• Attendance to Contract GMP QC Labs Symposium programme;
• Delegate pack, including conference papers;
• Refreshments throughout the day;
• Buffet lunch.

Registration closes on 3 September 2008.

 
How do I register?
This event is now fully booked. If you wish to be added to the waiting list and kept informed of future events on this topic please send an email to MHRA conferences (mhraconferences@mhra.gsi.gov.uk) with 'GMP QC Labs waiting list' in the subject line and your contact details in the body of the email.

 
Need more information?
If you have any queries with registering or require further information please e-mail the MHRA event team: mhraconferences@mhra.gsi.gov.uk or telephone on 020 7084 2903.