New ECA Guide on Integrated Qualification and Validation

In Europe and the US, regulations for qualification and validation have changed in recent years - regulators expect a risk-based approach. Nevertheless, quite a few pharmaceutical companies still work with the methods and documents of the former common practice. A fully integrated approach, such as the EU GMP Guideline Annex 15 and the FDA Guideline on Process Validation, can save a lot of time and money!

The online conference will focus on the following topics:

  • Integrated qualification and validation according to EU GMP Annex 15 from the inspector's point of view
  • ISPE Commissioning & Qualification Guide Version 2 (2019)
  • Good engineering practice in qualification - How do suppliers work?
  • Customer and supplier collaboration in integrated qualification and validation.
  • Remote FAT/SAT - tools that could be used outside of a pandemic situation.
  • ECA Qualification & Validation Guide and Tools: Risk-based qualification from URS to IQ, DQ, OQ to PQ
  • ECA Qualification & Validation Case Study: Fast and effective project management with suppliers
  • Supplier contracts during qualification
  • Case Study: What is the impact of pharmaceutical quality assurance in renovations and new buildings?
  • New Appendix: Electronic Documentation in Qualification Projects
  • Equipment Categorization: A Tool for Streamlining Qualification

The speakers at the online conference are all team members or reviewers of the guide and can answer any question, no matter how tricky. Ralf Gengenbach, Founder and Managing Director of gempex GmbH and member of ECA, will be presenting expert on the following topics:

How suppliers work: Good engineering practice in qualification

  • Basic workflows in CD, BD, DD and in EPCMQ projects
  • Project stakeholders: process and equipment engineers
  • Presentation of key documents in engineering processes
  • FAT, SAT and commissioning
  • How can a supplier support qualification?
  • Typical pitfalls of qualification

Supplier contracts on qualification

  • Legal requirements
  • What should be mandatory in a contract, and what is not absolutely necessary?
  • How can the contract support quality in the collaboration?
  • Presentation of the new chapter on contract drafting in the "ECA Guide to Good Practice"
  • Presentation of the new Annex on contractual agreements (checklist)

The online conference is aimed at all those affected by Annex 15 and the FDA Process Validation Guidance regarding qualification/verification and process validation activities.
The detailed program can be found on the  organizer's website.