|
For the GMP compliant manufacture of APIs and drugs it is mandatory, that the staff is highly qualified. Thus it is necessary to complement and renew
an academic education with continuous advanced training.
That’s the Certification Programme’s value. In addition to providing a GMP Certification Programme in German, CONCEPT HEIDELBERG also offers a comprehensive international programme on behalf of the ECA. Within the individual programmes you can modularly combine certain courses to complete a recognised qualification. So far, seven programmes are available:
Certified Validation Manager
more
Topics: e.g. Equipment Qualification, Process Validation, Cleaning
Validation
Certified Quality Assurance Manager - Pharmaceutical Production
more
Topics: e.g. CAPA, GMP Inspection, Quality System, Batch Record Review
Certified Quality Assurance Manager - API Production
more
Topics: similar to the Certified Quality Assurance Manager -
Pharmaceutical Production, but with a focus on ICH Q7A Compliance
Certified Quality Control Manager
more
Topics: e.g. Out-of-Specification Results (OOS), Validation of Analytical
Test Procedures, Impurities, Reference Standards, Stability Testing
Certified Pharmaceutical Engineering Manager
more
Topics: e.g. Good Engineering Practices, GMP-Compliant Design of
Equipment, Calibration
Certified Computer Validation Manager
more
Topics: e.g. User Requirement Specification (URS), GAMP Guide, Part 11,
Life Cycle Model
Certified Regulatory Affairs Manager
more
Topics: e.g. Marketing Authorisation, Common Technical Document (CTD),
Drug Master File (DMF), Certificate of Suitability (CEP)
To learn more about the ECA Certification Programme and the single certificates, please click
here.
|
