8th European GMP Conference - The biennial No 1 Event in Europe

Programme

Session I - Current Initiatives worldwide

This session will discuss the latest changes and current initiatives in EU GMP and FDA GMP regulations. In addition, the Mutual Recognition Agreement between the EU and US (FDA) will be discussed.

GMP Update 2019 and Outlook 2020 - current Trends and Developments in Europe, US
Major GMP developments and their impact for pharmaceutical industry
The revised EU & PIC/S GMP Annex 1 - implications and experiences
The new EU GMP Annex 21 on Importation and its implication
Additional GMP developments from EMA and FDA
Brexit and its consequenses for the European GMPs

The Mutual Reliance Initiative on EU-FDA Inspections: Current Status and next Steps
Details of the agreement
Consequences for EU and FDA Inspections
Transitory Provisions
Schedule and Procedure for the next steps

Brexit and increasing Drug Shortages: What does this mean for QA in Practice?
European Pharm Industry post Brexit
Impact on the product supply across Europe
GMP compliance - are we compromising quality now that UK is a 3rd country?
Long term impact on patient safety costs and supply

Session II - New and revised ECA Good Practice Guides – What QA needs to know and helpful tools

GMP requirements often lack concrete recommendations for implementation. Therefore ECA´s working and interest groups have been set up to develop so called Good Practice Guides. In this session you will get an update on the content of these Guides. Data Integrity has been the major GMP compliance issue in the past two years. Today, companies need to make sure that all sites, suppliers and contract labs comply with the regulatory requirements. This interactive session will discuss pragmatic approaches how this can be achieved. With the revision of FDA´s Process Validation Guidance and the Annex 15 a process validation life cycle became state of the art. Especially in the FDA guidance qualification and process validation are close together. How can this be achieved? This will be discussed, also referring to ECA´s Good Practice Guide on Modern Qualification. The ICH Q2 (R1) document about Analytical Method Validation will be revised. Why and the direction of the changes will be discussed. And how ECA´s Good Distribution Guide can be used for implementation and inspection will be presented too.

Data Integrity: How to manage oversight over suppliers, service providers, contract manufacturers and mutiple sites
Data Integrity implementation - Status of the industry 2019
ECA Data Integrity Guide version 2.0
ECA´s new Data Integrity Toolbox
How to ensure compliance with Data Integrity requirements

Integrating Qualification and Validation from a QA Perspective - introduction into ECA´s Modern Qualification Guide
What does Modern Qualification mean?
ECA´s Modern Qualification Guide - and the link to Modern Process Validation
Fast track facility projects using a modern qualification approach
Teaming up with suppliers and other partners
Subject matter experts and the modern role of QA in the future…?

What QA Needs to know about changes to ICH Q2(R1), Analytical Method Validation, and the proposed ICH Q14 on Analytical Procedure Development
Reasons for the need to revise ICH Q2(R1) - Why the change from Method to Procedure?
New lifecycle approach to the Validation for Analytical Procedures based on the FDA Process Validation model, 2011
USP General Chapter <1220>, Analytical Procedure Lifecycle, 2017
The ECA AQCG Guide to Analytical Procedure Lifecycle Management (APLM), 2018
The aims & objectives of ICH Q14, Analytical Procedure Development using analytical quality by design methodology (AQbD)

What QA Needs to Know About Good Distribution Practice compliance trends: The ECA/PQG Guide on Good Distribution Practice
What is state of the art regarding GDP?
What is the state of play regarding GDP implementation in industry
Frequent findings during GDP inspections and audit
The final version of the ECA and PQG Guide on the interpretation of GDP
How to use the Guide for GDP implementation and GDP inspection

Session III - GMP Inspectors meet Industry – Urgent Non-Compliance Issues

Recent FDA Warning Letters and GMP Non-compliance Reports in EMA´s EudraGMDP database show a great number of GMP findings. But what are most frequently observed GMP deviations at EU inspections? In this session you will learn from an inspector about recent inspection experience. An industry speaker will describe how companies with multiple manufacturing sites can prepare for successful GMP inspections.

Inspectors View: Non-compliance-issues - Is it all only about Data Integrity!?
Which areas are critical to trigger Non-Compliance Statement
What is critical with these areas?
Inpropper Data-Management
Deficiency examples from GMP inspections

Industry view: How to Make Sure That all Sites and Suppliers are in Compliance
Does industry make best use of the concepts laid down in the GMP rules?
The supply chain diagramm
The Technical (Quality) Agreement
The product specification file
The QP declaration
Auditing by yourself or a third party
Product Quality Review
Dr Ulrich Kissel Director Regulatory Affairs, ECA and Chairman, European QP Association

Session IV - Parallel Sessions & Workshops with Inspectors

Get involved in the ECA Interest and Working Groups. Each delegate will be invited to discuss the upcoming developments with the Chairs of the Groups and an EU Inspector.

You can address topics of interest and you can provide feedback on the currently planned activities. It is the aim of the Group to provide a platform for discussion with both colleagues from industry and regulatory authors.