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.
For questions relative to the ECA Certified Sterile Production Manager,
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)