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
- Equipment Qualification Forum
- 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 enquiry@gmp-compliance.org.