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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.
For questions relative to the ECA Certified Sterile Production Manager,
please contact
heimes@gmp-compliance.org.
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".
- Risk Management for sterile manufacturing
- Environmental Monitoring - Compliant and Reasonable
- Handling Failures in Sterile Manufacturing
- Process Simulation / Media Fills - GMP Requirements on the
Validation of Aseptic Processes
To get to the calendar with all courses and conferences currently offered
for this programme - including a link to the contents and a booking form -
please go here.
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