ECA Certified
Validation Manager

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

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