Introduction – Update ECA
Dr Afshin Hosseiny, Chairman ECA
GMP PART - 22 June 2021
Moderated by: Lance Smallshaw
SESSION Current GMP Initiatives Worldwide
This session will discuss the latest changes and current initiatives in GMP and GDP regulations.
GMP Update 2021 and Outlook 2022 – Current Trends and Developments in Europe and the US
- Regulation (EU) 2019/6Regulation (EU) Nr. 536/2014
- Reflection paper on Good Manufacturing Practice and Marketing
- Authorisation Holders
- Analytical Procedure Development and Validation (ICH Q14/Q2)
- The new EU GMP Annex 21 on Importation
- GMP Revisions – Annex 1 & 21
- Brexit and its consequences for the European QPs
Dr Bernd Renger, QP and immediate past chair of the EQPA
ICH Q 12: Views and Expectations of a GMP-Inspector
- Quality Risk Management
- Life Cycle Approach
- Views and Expectations
Dr Franz Schönfeld, GMP Inspector
How to Implement ICH Q 12 into Daily Practice of Manufacturers – What QA (and QPs) needs to know?
- What does QA (and QPs) need to consider?
- Some Quality systems become key
- Efficiency potential for Quality systems of manufacturing organizations
- ICH Q12 and key performance indicators
- Plan precisely, assess risks proactively, share transparently
Dr Ulrich Kissel, Chairman European QP Association
SESSION Industry Meets Inspectors
Remote/Online Inspection – from the point of view of the Russian Authority
Natalia Burlakina, Russian Federation
The EAEU Academy
Dr Ivan Guliaev, Russian Federation
Global Inspection Management: Cultural Diff erences to consider in hosting Competent Authorities
- General Organisation
- Roles and Responsibilities
- Cultural Aspects
Dr Jens-Uwe Rengers, Zürich, Switzerland
Annex 1 Revision: Comments from the Industry
- New requirements?
- New requirements!
- The role and improtance of Quality Risk Management
- Contamintation Control Strategy
Dr Ingrid Walther, Head of ECA´s adhoc Task Force for comments to the Annex 1 revision
Inspection – readiness for new Annex 1: Comments from the Inspector
- What is essential?
- What do I need to change or improve?
- Is it really such serious?
Dr Rainer Gnibl, GMP Inspector