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 The requirements to the quality assurance of active pharmaceutical
ingredients have increased enormously, among others, due to the
establishment of ICH Q7A "GMP for APIs." Therefore, highly qualified
experts are necessary to put these requirements correctly into practice.
The QA Manager - API production - learns the rudiments in one of the 3-day
intensive courses and can deepen this know-how according to his or her
focus by means of two further seminars.
In order to obtain this additional certificate, the applicant must
therefore attend one of the following 3-day intensive courses:
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ICH Q7A Compliance for APIs Manufactured by Chemical Synthesis or
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ICH Q7A Compliance for APIs manufactured by Cell Culture / Fermentation
as well as 2 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
- ICH Q7A Certified Auditor
- Qualification/Validation in Sterile Manufacturing
- APIs for Use in Clinical Trials
- Microbiological Facility Control
- GMP Compliance for Biopharmaceuticals
- GMP Compliance Auditor
- Microbiological Facility Control
- Modern API Facilities
- Masterclass "Microbiological Challenges for GMP/FDA
Compliance"
The following link leads you to upcoming
events recognised for the
Certified Quality Assurance Manager (ECA) - API Production.
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