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 Quality Assurance Managers are internal specialists for various compliance
topics. For this task, they need a wide-ranging knowledge. Depending on
the main emphasis of their activities, they have to acquire diverse
qualifications. The different seminars of this programme take this fact
into account.
In order to obtain the additional certificate, the applicant must attend
3 courses of the following choice.
-
GMP/FDA Compliance in Quality Assurance Units
- Out of Specification Results/ Failure Investigation
- GMP and FDA compliant Quality and Documentation
Systems
- How to Pass EU and FDA Inspections & GMP Compliance
Auditor Course
- Validation Manager
- Microbiology for Non-Microbiologists
- FDA/GMP Requirements on Environmental Monitoring
- Qualification/Validation in Sterile Manufacturing
- Microbiological Facility Control
- Process Simulation - GMP Requirements on the
Validation of Aseptic Processes
- EU-GMP and FDA Compliance in Pharmaceutical
Development
- European Aseptic Conference
- Masterclass "Microbiological Challenges for GMP/FDA
Compliance"
- GMP Compliance for Biopharmaceuticals
- FDA- what you need to know
- Efficient Supplier Qualification
- Good Distribution Practice and Cold Chain Management
After attending the third course, the applicant obtains the additional
certificate.
The following link leads you to upcoming
events recognised for the
Certified Quality Assurance Manager (ECA) - Pharmaceutical Production.
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