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

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