ECA Certified
Quality Control Manager

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. It provides guidance on ways of attaining best regulatory practice and compliance. In addition, it addresses tools for the efficient and effective management and performance of quality control laboratories today.

This programme will be of significant value to employees both in routine quality control and in analytical development laboratories, who are responsible for GMP compliance and laboratory organisations:

  • Analytical scientists
  • Analytical laboratory managers / supervisors
  • Employees working in the incoming goods control of APIs, excipients, and packaging materials
  • Contract laboratories personnel
  • Auditors responsible for assessing laboratory compliance and performance

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
  • Leachables and Extractables Testing and Assessment
  • Validation of Analytical Test Procedures and Measurement Uncertainty
  • New USP & FDA Approaches for HPLC
  • Design Control for Drug - Device Combination Products
  • Dissolution Testing Development - Quality Control and in vivo Relevance
  • Impurities Forum - Part I: General Strategies
  • Impurities Forum - Part II: Element Impurities
  • Impurities Forum - Post-Conference Workshop: The Elemental Impurities Database for excipients
  • Sampling Strategies - Is the √N rule always the Best?
  • Bioassays and Bioanalytics
  • Stability Testing for Biological/Biotechnological Drug Substances and Drug Products
  • FDA Compliance in Analytical Laboratories

Your Questions

For questions relative to the ECA Certified Quality Control Manager, please contact heimes@gmp-compliance.org.

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