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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? What criteria have to be applied for APIs, drug product formulation (including excipients and packaging), analytical methods and stability studies during development?

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".

  • GMP meets Development
  • ICH Q8 / ICH Q11 Training Course
  • Quality by Design in Pharmaceutical Analysis
  • Pharmaceutical Packaging Systems
  • GMP meets GCP
  • Quality by Design in Drug Product Development
  • Quality by Design in API manufacturing
  • How to write the Quality Part of an IMPD
  • Sticking – Capping – Lamination

Your Questions

For questions relative to the ECA Certified Pharmaceutical Development Manager, please contact heimes@gmp-compliance.org.

>>> 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; just click on any event in the list)

  
 GMP Conferences by Topics
 Quality Assurance
 GMP in Biotechnology
 Microbiology
 Regulatory Affairs
 GMP in Pharmaceutical Development
 Quality Control
 Storage, Distribution, Transportation
 Sterile / Aseptic Manufacturing
 Computer Validation
 Technical Operations
 GMP for APIs and Excipients
 Validation
 Medical Devices
 GMP Basic Training Courses
 Packaging