ECA Certified Sterile Production Manager

Sterile medicinal products, especially when manufactured under aseptic conditions, underlie a variety of GMP regulations; Regulations that are frequently adapted to the current state of knowledge and technology and that are by now are strongly harmonised internationally.
To manufacture sterile drugs compatible with GMP regulations, a proper technical environment, qualified staff and validated processes are required. For that reason this certification programme extensively covers the basics as well as the current matters of sterile production. In this GMP Certification Programme you will acquire comprehensive knowledge on all aspects of the manufacture of sterile medicinal products.

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 Sterile Production Manager”.

  • Environmental Monitoring – Compliant and Reasonable
  • Container/Closure Integrity Testing
  • GMP for Beginners in Sterile Manufacturing
  • Process Simulation / Media Fills – GMP Requirements on the Validation of Aseptic Processes
  • Isolator Technology Workshop

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