ECA Certified Computer Validation Manager

Computerised systems are in widespread use throughout the pharmaceutical industry. They are subject to the requirements of the various collections of pharmaceutical regulations. EU GMP Guide Annex 11 has been revised since 2022. The US FDA lays down requirements concerning electronic records / electronic signatures in 21 CFR Part 11 published 1997. Also, since 1994 the GAMP® Guide provides a worldwide acknowledged industry guideline for the validation of computerised systems - and is available as version 5 2nd edition since 2022. The basic guideline was and still is constantly expanded by various Good Practice Guides concerning specific aspects.

In the GMP Certification Programme "Computer Validation Manager" participants obtain a comprehensive knowledge of the basic principles for the validation of computerised systems, the requirements of 21 CFR Part 11 and specific aspects of the validation of computerised systems.

Courses and Conferences acknowledged

To receive the certificate, the applicant must attend three out of the following courses/conferences. After attending the third course, the applicant obtains the certificate “ECA Certified Computer Validation Manager”.

  • Cloud Computing in a GxP Environment
  • Computerised System Validation: Introduction to Risk Management
  • Computerised System Validation: The GAMP 5 Approach
  • Computerised System Validation: Leveraging Suppliers
  • Computerised System Validation Master Class
  • Computerised System Validation: How to Document CSV Activities
  • Computerised System Validation: Maintaining Control of Operation
  • SAP: Validation and GMP Compliance
  • IT / OT Infrastructure Qualification and Operation in a GMP Environment

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