ECA Certified Pharmaceutical Development Manager

Not only in the manufacturing of marketed products (c)GMP-Compliance is mandatory. Also in the manufacturing of IMP supplies, compliance with the applicable GMP Guidelines is obligatory. But which GMP and GCP requirements are the applicable ones? And do the requirements differ from clinical phase 1 to phase 3? And how do I apply them?

This Certification Programme has been designed by the ECA to broaden your knowledge and to consolidate the various aspects which need to be considered in a successful development of a new pharmaceutical product.

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 Pharmaceutical Development Manager”.

  • Stability by Design
  • GMP meets Development
  • ICH Q8 / ICH Q11 Training Course – From QbD to Process Validation
  • How to write the Quality Part of an IMPD
  • Lifecycle Management in Pharmaceutical Analysis
  • Pharmaceutical Packaging Systems – Part 1 Development
  • Granulation & Tableting
  • GMP meets GCP – Management, Supply and Quality Assurance of Clinical Trials
  • ICH Q12 – How to use the PACMP in Practice
  • Emulsions & Gels

Your Questions

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