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ECA - Modern Qualification

Modern Qualification (10. April 2019)

Objective

Pharmaceutical professionals and suppliers of equipment, systems and engineering to the pharmaceutical industry will get an overview of the “Modern Qualification” approach and the templates and examples for use in projects in the future. The course includes

  • User Requirement Specifications
  • Critical Aspects of manufacturing systems
  • Good Engineering Practice and its influence to leverage qualification activities

Cost-effective cooperation between suppliers and their pharmaceutical customers

Background

For pharmaceutical companies and suppliers to the pharmaceutical industry a good partnership on Testing, Qualification and Validation is increasingly important.

Project time and cost can be saved if the pharmaceutical requirements on Good Engineering Practices, Qualification and Validation are well known. Therefore ECA has developed a Good Practice Guide for “Modern Qualification” - a guide to effective qualification based on Customer-Supplier partnership.

The guide has been developed in partnership between pharmaceutical companies and suppliers of equipment, systems and engineering to the pharmaceutical industry. The first draft was made public at a conference in Berlin in September 2018 with participation from both European regulators and US FDA. This conference included a regulatory presentation on the Qualification and Validation expectations in Europe.

Qualification and validation have been mandatory activities for many years in the pharmaceutical industry. But new international regulations based on quality risk management principles can enable a better and more cost-effective approach to design, testing and documentation of supplier activities - in partnership with pharmaceutical customers.

You will get a free copy of ECA Good Practice Guide: “Modern Qualification – A guide to cost effective qualification based on Customer--Supplier Partnership.

Moderator

Gert Moelgaard, ECA Validation Interest Group

Target Audience

Managers from the pharmaceutical industry and especially their suppliers of pharmaceutical equipment and services who

  • may be influenced by the Annex 15 revision and FDA Process Validation Guidance regarding Qualification/Verification and Process Validation activities and
  • want to see how an integrated approach to qualification and validation can enable successful fast-track Projects

Programme (10. April 2019)

CONGRESS KEYNOTE
EU GMP Inspection in Sterile/Aseptic Production
Klaus Eichmüller, Wolnzach, c/o Regional Council Darmstadt, GMP Inspectorate, Germany
Head of Inspectorate

  • Main focus areas of inspections
  • Frequently detected findings
  • Data Integrity issues – where are possible weak spots?
  • Possible new areas due to the revision of Annex 1 and further regulatory changes

 

Welcome and introduction to ECA Modern Qualification Guide
Gert Moelgaard, ECA Validation Interest Group

  • ECA's Modern Qualification Guide 
  • Good cooperation between suppliers and customers - what works?
  • What can a supplier do to enable cost-effective qualification projects? 
  • Trends in Qualification and Validation

 

European requirements for qualification and validation
Klaus Eichmüller, Danish Wolnzach, c/o Regional Council Darmstadt, GMP Inspectorate, Germany
Head of Inspectorate

  • Qualification and validation requirements in EU Annex 15
  • The importance of good cooperation between customers and suppliers
  • Qualification observations from an inspector's perspective
  • Qualification and Validation in the future?

 

Using ECA’s Modern Qualification Guide as a pharmaceutical customer
Eva-Maria Baumgartner, Syntacoll

  • International standard, common language with suppliers
  • Using the best ideas in our company
  • Categories of equipment: benefit during qualification
  • What would we expect from our suppliers?
  • Integrated Qualification and Validation from a pharma perspective

 

Integrated Qualification – Customer Supplier Collaboration as outlined in the new ECA Guideline
Dr. Berthold Düthorn, ECA Validation Interest Group

  • Risk Assessment and Risk Management
  • Specifications – task for both contractual partners
  • Test documentation and execution
  • Importance of Qualification Project Management
  • Collaboration spirit as key success factor

 

Open discussion of ECA’s Modern Qualification Guide and feedback to the next version
Gert Moelgaard, ECA Validation Interest Group

  • The development of the Modern Qualification Guide
  • Plans for a new Integrated Qualification and Validation guide
  • ECA Conference with launch the next version
  • Feedback