ECA Certified
API Production Manager

ECA Certified API Production Manager

The standards for GMP compliant manufacture of APIs are laid down in ICH Q7 and have been established already in 2001. NeverthelessTherefore these requirements are not trivial at all and, highly qualified experts are necessary to put them se requirements correctly into practice. The ECA Certified API Production Manager programme offers courses and conferences where the basic GMPs for APIs as well as special aspects regarding GMP compliant API production are discussed intensively. 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 This programme is of significant value for both employees and senior management of API production departments.

Courses and Conferences acknowledged

To obtain the additional certificate, the applicant must attend three out of the following courses / conferences. After attending the third course, the applicant obtains the additional certificate "ECA Certified API Production Manager".

  • ICH Q7 Compliance for APIs Manufactured by Chemical Synthesis
  • ICH Q7 Compliance for APIs Manufactured by Cell Culture/Fermentation
  • ICH Q7 Auditor Training Course
  • API Regulatory Starting Materials
  • Handling of foreign particles in APIs
  • Quality by Design in API Manufacturing

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