European GMP & GDP Forum – the largest Conference of its Kind in Europe
So far, the ECA has been running the GMP and GDP Conference separately every two years. Now, these two events have been combined to create a new platform: the European GMP & GDP Forum. The first Forum will be held from 22-24 June 2021, both as an on-site meeting in Heidelberg, Germany, or Live Online - allowing participants to decide about the preferred option of participation.
On three days, participants will concentrate on the current issues and challenging questions in the two subject areas. Day 1 will be dedicated to GMP, day 2 will be a combination of both GMP and GDP, and the final day will focus on GDP topics only. This will allow participants to take advantage of the event based on the personal needs - just for one of the three days, two days or all three days.
The GMP Day One
The GMP part on Day 1 is comprised of two main sessions. Session A will cover the current GMP initiatives in the EU and the US. Dr Bernd Renger will present updates on EU GMP Annex 1 and 21. He will also provide updates from ICH. For example, Q14 is a new Guideline on Analytical Procedure Development and Validation. Further, the Q2 Guideline on the Validation of Analytical Procedures will be updated in parallel. And ICH's Q12 on Pharmaceutical Product Lifecycle will also have a major impact on the GMP environment. Dr Franz Schoenfeld, an EU GMP Inspector, and Dr Ulrich Kissel, Chairman of the European QP Association, will therefore share their view about expectations from the authorities and industry implementation.
Session B is dedicated to "Industry meets Inspectorates". There, speakers from industry and from GMP inspectorates will discuss latest GMP developments such as EU GMP Annex 1 Revision as well as Global Inspection Management.
The Joint GMP & GDP Day Two - Workshops to discuss Various Topics in more Detail
The joint GMP and GDP day 2 will highlight topics with a major impact on GMP and GDP compliance - such as Brexit consequences and the EU GMP Annex 21 "Import of Medicinal Products".
To discuss latest developments in specific subject areas in more detail, participants can also choose one out of five parallel sessions offered by the ECA's Interest Groups on the second day:
Option 1 is a workshop organised by the Validation Group with Qualification & Validation issues in the centre of discussions. This interactive session around the leading question "How does supplier integration fit with GMP?" will offer the opportunity to discuss some of new developments in qualification and validation activities:
- How can qualification and GEP interact?
- How can suppliers be integrated?
- Categorisation of equipment - a tool for streamlining qualification efforts
- Requirements for electronic qualification documentation
6/7 May 2021
Live Online Training: Lean GMP-Systems
How sure are you that your Laboratory Instrument/System is fit for its intended Purpose? This is the question to be answered in workshop 2, offered by the Quality Control Group. Specifically the following topics will be discussed there:
- Introduction to the ECA AQC Group Guideline on Analytical Instruments and Systems Qualification Lifecycle
- Overview of USP General Chapter and revision of spectroscopic General Chapters USP and their relationship to the newly proposed analytical procedure lifecycle in USP
- Reference standards for calibration and establishment of acceptance criteria for 'fitness for purpose'
Current Data Integrity issues in the GMP area will be in the centre of discussions in the Data Integrity & IT Compliance Group's workshop (option 3) - for example providing the opportunity to get an idea on how you prepare for a Data Integrity inspection from the industry's view. Other topics will be Data Integrity Risk Assessment as well as latest Data Integrity Inspection findings.
Options 4 and 5 will be offered by the GDP Group. One of the two workshops will concentrate on How to Identify and Manage Falsified Medicines in the Supply Chain, and more specifically:
- What is a suspected falsified medicine?
- How to identify falsified medicine in your workplace?
- How to approach the investigation of a suspected pack?
- What should the end user do with the pack?
- Routine monitoring of incoming goods
- Who should manage communication with the end users?
The group's second workshop will concentrate on Risk Management in GDP Warehouse. The risk-based approach is a fundamental requirement for processes in the GDP environment. Risk management is one of the mandatory basic elements. It is applicable to a variety of activities and processes. This workshop will therefore cover challenges and possible solutions concerning risk management in GDP warehouses. Different examples will be discussed.
Thursday, 6 May 2021 9 .00 - 13.00 h
Live Online Training: Excel in the GxP-regulated Environment
GDP on Day Three
The GDP Day will be dedicated to case studies from different companies. For example, the switch from Air-freight to Sea-Freight will be presented by Saddam Huq from Glaxo SmithKline (GSK). Jochen Heinzel from F. Hoffmann-La Roche will present "the Roche quality governance model for distribution to direct markets". Other presentations will highlight expectations for Master Data in the GDP environment, GDP responsibilities for Financial Trading Organisations and more.
All participants will also receive an exclusive package of the latest ECA Guidelines, e.g. the Guidelines on Data Integrity, Integrated Qualification and Validation, GDP Interpretation.
To learn more about the first GMP & GDP Forum, the topics and presentations in detail and the speakers, please visit https://www.gmp-conference.org/
... is Managing Director of CONCEPT HEIDELBERG.