Presented by
Management Forum
Understanding and Interpreting the Proposed Changes to EU (European Union) GMP (Good Manufacturing Practice) Annex 11 Training Course
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
- Format: Live online
- CPD: 3 hours for your records
- Certificate of completion
Overview
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.
Benefits of Attending
- Understand the potential impact of changes in Annex 11 on the operation and support of computerised systems
- Know the additional requirements for agreements with suppliers
- Be aware of the impact of the update on SaaS providers of regulated solutions
- Secure early engagement with suppliers to ensure technical controls can meet the changes in regulations
Who Should Attend
- Process Owners (in regulated areas) and System Owners (in IT departments) responsible for the operation of GMP computerised systems
- Computer System Validation (CSV) personnel and consultants involved with validation of regulated computerised systems
- Quality Assurance personnel involved with oversight of computerised systems
- Suppliers who sell into regulated laboratories to check if any changes are required to the technical controls in their software
- Software as a Service (SaaS) suppliers to understand the potential changes to their role that the proposed updates will bring
The Understanding and Interpreting the Proposed Changes to EU GMP Annex 11 course will cover:
- Introduction to the course and the trainer
- Overview of the proposed Annex 11 changes
- Audit trail changes: do your systems meet these requirements? If not, what are you going to do about it?
- Changes impacting software and SaaS suppliers from agreements to validation support
- Understanding the impact of changes on validation of computerised systems
- Changes for IT support of computerised systems
- Summary of the course
Bob McDowall
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:
- 30% off the 2nd delegate*
- 40% off the 3rd delegate*
- 50% off the 4th delegate*
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
- GBP 299 349
- EUR 429 499
- USD 501 579
Until 13 Aug
- 1 day live online training
- Browser-based, no download usually required
- See presenters and interact with fellow attendees
- Download documentation and certification of completion
- Fair transfer and cancellation policy
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
- GBP 299 349
- EUR 429 499
- USD 501 579
Until 17 Dec
- 1 day live online training
- Browser-based, no download usually required
- See presenters and interact with fellow attendees
- Download documentation and certification of completion
- Fair transfer and cancellation policy
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.
