EU GMP Revision: Chapter 4, Annex 11, Annex 22
What do the changes to the guideline mean for your practice?
- EU GMP Guidelines under revision: Your to-do list
- Changes presented in a concise and understandable way
- Tips for efficient implementation in practice
- Officially certified: ISO 9001 + 21001
Online-Seminar
Ab
690,00 €
zzgl. MwSt.
Leistungen & Ablauf
Veranstaltung - 690,-€ zzgl. MwSt.
The participation fee includes documentation for download, a certificate, access to the Learning Space and technical support including PreMeeting.
Period:
from 9:00 am until 1:30 pm CET - online seminar
You may dial in 30 minutes before the lecture starts
Buchungsdetails
Online-Seminar
Ab
690,00 €
zzgl. MwSt.
Leistungen & Ablauf
Veranstaltung - 690,-€ zzgl. MwSt.
The participation fee includes documentation for download, a certificate, access to the Learning Space and technical support including PreMeeting.
Period:
from 9:00 am until 1:30 pm CET - online seminar
You may dial in 30 minutes before the lecture starts
EU GMP Revision: Are you prepared for the guideline changes in Chapter 4 (Documentation), Annex 11 (Computerised Systems), and Annex 22 (AI)? Receive your update - presented in a simple and understandable format - on the (expected) changes, as well as tips for practical implementation from our two experienced experts.
Your speakers
Dr. Cornelia Hunke
Evangelisches Krankenhaus Göttingen-Weende,
GERMANY
Head of the Quality and Risk Management Department
Cornelia has many years of experience in industry, public service, and international research. She…
Your speaker
Dr. Cornelia Hunke
Evangelisches Krankenhaus Göttingen-Weende,
GERMANY
Head of the Quality and Risk Management Department
Cornelia has many years of experience in industry, public service, and international research. She held a senior position at the Federal Institute for Risk Assessment (2015-2022) with responsibility for the accreditation of laboratories and NRLs. She has several years of consulting expertise as a certified auditor and lead QA in ISO, GxP compliance, and digitization in the laboratory environment. Since the end of 2025, she is a team lead for QM and risk management in hospital management at a clinic in Göttingen.
Dr. Timo Kretzschmar
TiKrESolution - Business and IT Consultancy, GxP Audits/Trainings/Consultation,
Vienna, AUSTRIA
After completing his dissertation in technical chemistry, Dr Timo G. Kretzschmar worked at TÜV Austria;…
Your speaker
Dr. Timo Kretzschmar
TiKrESolution - Business and IT Consultancy, GxP Audits/Trainings/Consultation,
Vienna, AUSTRIA
After completing his dissertation in technical chemistry, Dr Timo G. Kretzschmar worked at TÜV Austria; starting in 2003, he served as the head of quality at a pharmaceutical analytics CRO near Vienna. From 2016 to 2019, he served as an inspector for GLP and computerized GxP systems at the pharmaceutical regulatory agency AGES/BASG in Vienna, and subsequently worked for six years as a senior consultant for GxP systems and as a project manager. Since 2024, he has returned to his role as Head of Quality at the CRO. In parallel, he has been a lecturer at universities of applied sciences and traditional universities since 1995. Since 2023, he has been leading TiKrESolution (GxP Consulting) in Vienna.
What to Expect
- EU GMP Guideline Revision
- Chapter 4 "Documentation" (Revision)
- Annex 11 "Computerised Systems" (Revision)
- Annex 22 "Artificial Intelligence" (New)
Who Should Attend
The seminar is beneficial for:
- Specialists from GMP-regulated environments (manufacturers and control laboratories)
- Distributors
- Suppliers in the field of data processing/IT
Objective of the Event
During this half-day seminar, our two experts will provide you, with an overview with relevant details presented in an easy-to-understand format, of the current draft versions of the EU GMP guidelines on Chapter 4 (Documentation), Annex 11 (Computerised Systems), and the new Annex 22 (Artificial Intelligence).
You will receive recommendations for action to prepare for the planned changes at an early stage and can already start setting a strategic course for your company.
After attending the seminar, you will be able to assess the expected requirements and proactively plan initial adaptation measures.
Your Benefit
By participating in the seminar, you will gain a decisive knowledge advantage in "interpreting" the revision of the EU GMP guidelines (draft version presented). You will also save valuable time and resources thanks to the early development of implementation strategies.
The half-day format can be easily integrated into your daily work routine.
Programme
from 09:00 am until 01:30 pm CET
You may dial in 30 minutes before the sessio
09:00
09:15
Dr Cornelia Hunke
- Fundamentals of EU GMP regulations
- Concept/approach to new regulations
- Overview of planned innovations
09:45
Dr Timo Kretzschmar
- Paper and electronic data integrity
- GDocP newly defined, including ALCOA ++
- (Electronic) signatures (eIDAS)
- Retention and archiving (electronic, physical, hybrid)
11:00
11:15
Dr Timo Kretzschmar
- Relation between data integrity and computer system validation is being turned on its head
- Focus: Cloud, audit trail, security
- Tips for practice
12:30
Dr Cornelia Hunke
- Basic structure of the new GMP annex
- Acceptance criteria, testing and trustworthiness
- Outlook on other relevant AI guidance documents (e.g. EMA, FDA)
- Implementation tips
13:15
Both Speakers
13:30
Welcome, introduction, expectations
09:15
EU GMP Guideline Revision
EU GMP Guideline Revision
Dr Cornelia Hunke
- Fundamentals of EU GMP regulations
- Concept/approach to new regulations
- Overview of planned innovations
09:45
Chapter 4 "Documentation" (Revision)
Chapter 4 "Documentation" (Revision)
Dr Timo Kretzschmar
- Paper and electronic data integrity
- GDocP newly defined, including ALCOA ++
- (Electronic) signatures (eIDAS)
- Retention and archiving (electronic, physical, hybrid)
Biobreak
11:15
Annex 11 "Computerised Systems" (Revision)
Annex 11 "Computerised Systems" (Revision)
Dr Timo Kretzschmar
- Relation between data integrity and computer system validation is being turned on its head
- Focus: Cloud, audit trail, security
- Tips for practice
12:30
Annex 22 "Artificial Intelligence" (New)
Annex 22 "Artificial Intelligence" (New)
Dr Cornelia Hunke
- Basic structure of the new GMP annex
- Acceptance criteria, testing and trustworthiness
- Outlook on other relevant AI guidance documents (e.g. EMA, FDA)
- Implementation tips
Recap and Q&As
End of seminar
Downloads
Request the documents using our form.
Brochure
Whitepaper_Stability-Testing-of-Drug-Products
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We are happy to advise you personally and individually.
Dr. Birgit Wessels
Conference Manager
+49 6221 500-652
b.wessels@forum-institut.de