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ECA Certified Regulatory Affairs Manager

  

Regulatory Affairs Managers are internal specialists for various regulatory affairs and regulatory compliance topics. For this task, they need a wide-ranging knowledge. Due to the rapidly growing numbers of new and revised guidelines they also need to update this knowledge frequently. Depending on the main emphasis of their activities, they also have to acquire diverse qualifications. The seminars and conferences of this programme take this into account.

 

Your Questions

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

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 Regulatory Affairs Manager".

  • The Regulatory Compliance Expert
  • CTD, CEP and Active Substance Master File
  • Annual APIC/CEFIC European Conference on Active Pharmaceutical Ingredients, Regulatory Affairs Part
  • Getting approval of Generics in the EU and the US
  • Drug Master File Procedures in the EU, USA and Japan
  • How to write the Quality Part of an IMPD
  • Handling Changes and Variations

>>> 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