ECA Certified Validation Manager

With FDA’s new Process Validation Guidance validation requirements will become more complex.

In addition to other requirements the revised Annex 15 also asks for a Process Validation Life Cycle. For ‘ensuring that all necessary validation is carried out’ (EU GMP Guide), many firms have introduced a position called validation manager. For this reason, the ECA has established the Certified Validation Manager Module. Attend a compulsory course, “The Validation Manager”, as well as two further courses from our validation programme to obtain the certificate for this high-level additional qualification.

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 Validation Manager".

  • Cleaning Validation
  • Process Understanding – Statistical Process Control as a tool to get there
  • Ongoing/Continued Process Verification  
  • Process Validation in the light of the Annex 15 and FDA requirements
  • The Validation Manager in the Pharmaceutical Industry
  • Launch Conference – ECA’s new Integrated Qualification and Validation Guide
  • Advanced Level Live Online Training: SPC rules in the real world for a Continued/Ongoing Process Verification Plan

Your Questions

For questions relative to the ECA Certified Validation Manager, please contact

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