Elements of a GMP-Compliant Quality Control Laboratory

female researcher carrying out research experiments in a chemist


The quality control (QC) unit serves an important role in the (bio)pharmaceutical industry assessing and measuring specific and pre-defined parameters to ensure the safety and quality of (bio)pharmaceutical products. Topics discussed in this course include an overview of regulatory requirements, QC laboratory activities including raw materials, in-process and finished product testing, and handling out-of-specification (OOS) test results. Equipment qualification, method validation, and vendor qualification will also be covered. Practical examples, case studies, and hands-on activities will be used to illustrate FDA QC laboratory hot-button issues and regulatory compliance as related to the cGMP-compliant QC laboratory.


  • Define parameters that determine the safety and quality of biopharmaceutical products
  • Discuss cGMPs as defined in 21 CFR 211 for Quality Control units, and how they apply to QC regulatory requirements
  • Know how to efficiently address deviations and OOS results
  • Discuss equipment calibration, qualification, and methods validation
  • Explain the importance of accurately maintaining appropriate documentation
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Course Features

  • Lectures 0
  • Hands-On Training 0
  • Duration 4.5 hours
  • Skill level All levels
  • Wet Lab Yes
  • Max Students 24
  • Assessments Yes