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FDA cGMP: Laboratory Controls

Date: to be confirmed
Instructor: Dr. Mel Dong
Location: to be confirmed

This course reviews the GMP requirements, and their interpretation and application to quality control chemistry and microbiology laboratory operations. The topics include the essential laboratory systems, programs, and procedures; the current GMP compliance issues, and the FDA's expectations for laboratory systems and controls; and the interpretations of the GMP requirements on testing for release (211.165). This course also includes group exercises on the review, analysis of, and response to, FDA-483 observations for laboratories.

  • General GMP Requirements and Laboratory Controls
    • Samples, reagents and reference standards
    • Instrument calibration, maintenance and qualification
    • Retesting, investigations and change control
    • Analytical systems and procedures
    • Personnel qualification and training
    • Stability program
    • Raw material testing, retention sample program
  • Microbiology Laboratory Controls
    • Media control, media growth promotion, sterility testing
  • Laboratory Procedures and Documentation
    • SOPs, instrument logs, raw data, electronic records
  • Analytical Method Validation