ECA Certified
Computer Validation Manager

ECA Certified Computer Validation Manager

Computerised systems that illustrate or control quality-relevant processes are in widespread use throughout the pharmaceutical industry. Not only are they subject to the requirements of the various collections of pharmaceutical regulations for the validation of these systems, but since 1997 the US authority FDA lays down requirements concerning electronic records / electronic signatures in 21 CFR Part 11.

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 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
List of all courses and conferences currently offered and acknowledged in this programme
(including detailed information on every event – venue, dates, fees and agenda as PDF)

Your Questions

For questions relative to the ECA Certified Computer Validation Manager, please contact enquiry@gmp-compliance.org.

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