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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.

Your Questions

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

Courses and Conferences acknowledged

To receive the certificate, the applicant must attend three courses / conferences which are recognized for the certification programme. After attending the third course, the applicant obtains the certificate "ECA Certified Sterile Production Manager". Please find below a list of potential training courses

  • Basics in sterile manufacturing
  • Risk Management in sterile manufacturing
  • Environmental Monitoring
  • Handling Failures in Sterile Manufacturing
  • Process Simulation / Media Fills
  • Current technologies in sterile manufacturing (Barrier Systems – Prefilled syringes etc.)

>>> 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