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Conferences - GMP Certification Programme

 
  

Certified Quality Assurance Manager (ECA) - API Production -

  

The requirements to the quality assurance of active pharmaceutical ingredients have increased enormously, among others, due to the establishment of ICH Q7A "GMP for APIs." Therefore, highly qualified experts are necessary to put these requirements correctly into practice. The QA Manager - API production - learns the rudiments in one of the 3-day intensive courses and can deepen this know-how according to his or her focus by means of two further seminars.

In order to obtain this additional certificate, the applicant must therefore attend one of the following 3-day intensive courses:

  • ICH Q7A Compliance for APIs Manufactured by Chemical Synthesis or
  • ICH Q7A Compliance for APIs manufactured by Cell Culture / Fermentation

as well as 2 courses of the following choice:

  • GMP/FDA Compliance in Quality Assurance Units
  • Out of Specification Results / Failure Investigation
  • GMP and FDA compliant Quality and Documentation Systems
  • How to Pass EU and FDA Inspections & GMP Compliance Auditor Course
  • Validation Manager
  • Microbiology for Non-Microbiologists
  • ICH Q7A Certified Auditor
  • Qualification/Validation in Sterile Manufacturing
  • APIs for Use in Clinical Trials
  • Microbiological Facility Control
  • GMP Compliance for Biopharmaceuticals
  • GMP Compliance Auditor
  • Microbiological Facility Control
  • Modern API Facilities
  • Masterclass "Microbiological Challenges for GMP/FDA Compliance"

The following link leads you to upcoming events recognised for the Certified Quality Assurance Manager (ECA) - API Production.