Presented by
Management Forum
This half-day course will provide an essential update on the proposed changes to EU GMP Annex 11 and will enhance delegate's understanding of the implications on working practices, as well as including a control framework for AI and ML.
17 September 2024
+ 21 January 2025 »
from £299
Annex 11 for Computerised Systems is the regulation for both the European Union and counties working under PIC/S GMP (Pharmaceutical Inspection Cooperation Scheme), it was originally issued in 1992 and upgraded in 2011. A concept paper on the revision of Annex 11 contains a proposal published by EU and PIC/S to revise Annex 11 containing 33 areas for update and extension to include a control framework for Artificial Intelligence and Machine Learning (AI/ML).
This course will prepare you for the implications of the changes on working practices and will provide an opportunity to discuss the complexities with an expert in this field.
The programme will include facilitated discussions and polls using www.menti.com to explore some of the more interesting changes proposed for Annex 11.
This course is part of our GxP training (Good x Practice) course collection, which features a variety of topic areas to ensure you comply with the most recent quality guidelines. For more information on the latest EU GMP regulations, see our GMP training course covering the Annex 1.
Bob McDowall is an analytical chemist with over 50 years’ experience including 15 years working in the pharmaceutical industry and over 30 years’ working for the industry as a consultant. Bob has been involved with the validation of computerised systems for over 35 years and is the author of two editions of a book on the validation of chromatography data systems and one on data integrity and data governance for regulated laboratories. He was presented with the 1997 LIMS Award for advances in the subject including editing the first book on the subject. He writes the Questions of Quality column for LCGC International and Focus on Quality column for Spectroscopy. Bob was a subject matter expert input and review contributor to the GAMP Records and Data Integrity Guide and two of the data integrity Good Practice Guides.
NEW higher discounts for multiple bookings - bring your colleagues to make your training budget go further:
Please contact us for pricing if you are interested in booking 5 or more delegates
17 September 2024
Live online
14:00-17:00 UK (London) (UTC+01)
15:00-18:00 Paris (UTC+02)
09:00-12:00 New York (UTC-04)
Course code 14377
Until 13 Aug
Not ready to book yet?
for 7 days, no obligation
21 January 2025
Live online
14:00-17:00 UK (London) (UTC+00)
15:00-18:00 Paris (UTC+01)
09:00-12:00 New York (UTC-05)
Course code 14378
Until 17 Dec
Not ready to book yet?
for 7 days, no obligation
* Early booking discounts may not be combined with other discounts or offers. As such, the discounts for 2nd/3rd/4th delegates are based on the full price; and apply only when booking multiple delegates on the same date.
Multiple colleagues? See above for details of our discounts for 2, 3, or 4 delegates. For more, talk to one of our training experts to discuss how to: