ECA Certified Quality Control Manager
The most frequently cited cGMP non-compliances are often found in analytical laboratories - showing the importance of the pharmaceutical quality control and the Quality Control Manager. Further, the QC Manager has to observe a multitude of GMP requirements (FDA, EMA, WHO, Pharmacopoeias, etc.). The programme “ECA Certified Quality Control Manager” lets you qualify as a specialist for analytical GMP laboratories.
Courses and Conferences acknowledged
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 Quality Control Manager”.
- Analytical Instrument Qualification
- Handling OOT Results/Handling OOS Results
- Stability by Design
- EU GMP-/FDA-compliant Sampling
- Dissolution Testing
- QC Compliance Manager
- Reduced Sampling/Reduced Testing
- Analytical Methods for Cleaning Validation
- Ph. Eur., USP and other Pharmacopoeias – Dealing with different compendial methods
- GMP/FDA Compliance in Analytical Laboratories
- Validation of Analytical Test Procedures and Measurement Uncertainty
- Stability Studies to Support Shipping/Distribution of Pharmaceuticals and Biopharmaceuticals
- Setting Specifications and Acceptance Criteria
- Stability Testing for Drug Substances and Drug Products
- Practical Statistical Tools for Analytical Laboratories
- Bioassays and Bioanalytics
- Stability Testing for Biological/Biotechnological Drug Substances and Drug Products
- Leachables and Extractables
- Quality Control of Starting Materials (APIs and Excipients)
Your Questions
For questions relative to the ECA Certified Quality Control Manager, please contact enquiry@gmp-compliance.org.