Two ECA GMP Guides covering Engineering & Equipment Qualification for free

Good Engineering Practice is used in planning & commissioning activities and can be applied in qualification activities too. So, there is an overlap between commissioning and equipment qualification. Therefore, two of the ECA's Good Practice Guides are linked. The ECA Validation Group's Guide on Integrated Qualification and Validation - A guide to effective qualification based on Customer-Supplier Partnership assists you in streamlining qualification activities in practice as much as possible, while remaining GMP-compliant. The GMP Equipment Design Guide, a road map to GMP compliant design, illustrates the generally applicable requirements for the design of equipment. It provides information on surfaces, hygienic design, pipework and more.

Due to this link, the ECA has decided to offer both guides at two ECA online training courses:

At the Live Online Qualification and Validation Forum on 14/15 November 2023 you will get to know the latest version 2.2 of the Guide on Integrated Qualification & Validation, concentrate on efficient qualification concepts supported by electronic means and supplier competencies, and you will further discuss topics like

  • Modern Qualification and Validation from a European inspector's view: ECA Good Practice Guide and the relation to EU GMP Annex 15 
  • Integrated Qualification and GMP Equipment Design: Two ECA guidelines in practice 
  •  Equipment Categorization - a tool to streamline qualification 
  • Critical Aspects Risk Assessment (CARA) - new chapter to clarify risks 
  • Survey to develop the guide further on 
  • Case Study Customer Supplier Cooperation - A Project Example 
  • Validation - How to overcome Challenges with Paper-Based CQV Approaches 
  • Paperless Validation and Qualification System Implementation and Experiences

In the Live Online Training GMP compliant Equipment Design - From Process & Product Requirements to an appropriate Equipment Design on 22/23 November 2023 you will become familiar with issues like 

  • Relationship between GMP Design and Qualification 
  • Hygienic Design as basis for cleanability and GMP-Design 
  • Risk based Approach to Selection of Materials 
  • Requirements for Product Contact Surfaces 
  • Pipework, Fittings & Welding 
  • Process Environment 
  • Electrical Engineering & Measurements 
  • Automation & Control 
  • Documentation in the Life Cycle of Equipment 
  • Quality Assurance for Equipment Suppliers 

Take advantage of the opportunity to receive two ECA Good Practice Guides as a free add-on. We look forward to welcoming you there.

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