Equipment Qualification Good Practice Guide - Overview and Inspector's View

Every 2 years, the ECA European Compliance Academy organizes the large GMP & GDP Forum with numerous high-level technical contributions: Expert presentations, regulatory updates and discussion on emerging trends and applications in practice.

In 2025, the conference will take place from June 24 to 26. The renowned event offers plenty of space for exchanging experiences on the hot topics.

Ralf Gengenbach, Managing Director of gempex GmbH and Chairman of the ECA Validation Group, will give a presentation on "Version 3.0 Equipment Qualification Good Practice Guide" on June 25 in a co-lecture with Dr. Franz Schönfeld, GMP / GDP Inspector at the local inspectorate for medicinal products and active substances of the District Government of Upper Franconia.

The key points of the lecture are:

  • Overview about ECA’s Qualification and Validation Guide
  • GEP Good Engineering Practice versus GMP Good Manufacturing Practice
  • How to integrate suppliers in qualification activities
  • Focus on critical aspects and risk management
  • Inspector’s view on outsourcing of qualification activities

The program and a registration form are available on the ECA Academy's website.  

For any questions about GMP compliance, efficient qualification and inspection readiness, please contact Ralf Gengenbach via contact@gempex.de.

 

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