WHAT'S NEW IN THE GMP ENVIRONMENT?
The European Compliance Academy (ECA) organises their European Good Manufacturing Practice (GMP) Conference biennially. On 06-07 May, 2019, the 8th European GMP Conference will take place in Heidelberg, Germany. This time, the Conference is also an opportunity for celebration - the ECA celebrates their 20th birthday at Heidelberg Castle.
What are the GMP Conference's topics this year? How will you profit from participating?
You will be informed of all changes which took place in 2018 and those scheduled for 2019. Furthermore, you will be provided an outlook for the year 2020. The changes to Annex 1 of the EU GMP Guidelines will be the focus of this talk. One of the significant changes of 2019 might be caused by the impending Brexit: Drug Shortage. Hence, the possibility of drug shortages caused by Brexit and Brexit's influence on supply chains on Europe will be discussed at the conference. Another important GMP issue is the further development of the Mutual Recognition Agreement (MRA) between the EU and the USA.
Matthew Scherer, Assistant Health Attache and International Programm and Policy Analyst for FDA, will provide an update on the MRA.
There are seven Interest and Working Groups which are part of the ECA Foundation. These groups regularly develop documents meant to assist in the interpretation of GMP, such as Good Practice Guides, guidelines or matrices. The new documents on Data Integrity (e.g. Data Integrity Toolbox), on the implementation of qualification activities into process validation (Modern integrated Qualification), on Analytical Procedure Lifecycle Management (APLM) and on the ECA/PQG Guide for Good Documentation Practice (GDP) will be introduced and their applicability in practice will be elucidated.
Recommendation
Berlin, Germany4/5 December 2024
Root Cause Analysis
From a European inspector, you will also learn which Non-Compliance issues are the most frequent at present - and if they are indeed data integrity deficiencies. Additionally, there will be a talk on "Inspection- Readiness" across sites from the industries' point of view.
The Conference's subtitle is "Industry meets Inspectorates". True to this motto, Parallel Sessions with moderators from the pharmaceutical industry and authorities will be held on the following topics:
- Validation Group: How to safe time and money in qualification and validation but comply with GMP?
- Data Integrity Task Force: How to manage oversight over suppliers, contract manufacturers and multiple sites?
- GDP Association: How to manage the interface between GMP and GDP?
As a special offer, you will receive all new or revised ECA Guidance documents free of charge:
- Data Governance and Data Integrity for GMP Regulated Facilities (Version 2)
- Analytical Procedures Lifecycle Management Guideline
- OOE and OOT Guidance Management Document
- Modern Qualification - A guide to effective qualification based on Customer-Supplier Partnership
- Good Distribution Interpretation Guide (ECA /PQG)
- Latest Version of GMP Matrix (comparision of EU GMP, FDA cGMP and ISO 9001)
Website
For further information on the conference and registration, please visit www.gmp-conference.org.
Author:
Sven Pommeranz
... is Operations Director and organises and conducts courses and conferences on behalf of the ECA Academy in the area validation.
