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FDA cGMP: Laboratory Controls

Date: December 4-5, 2017 
Instructor: John Y. Lee
Location: Copenhagen, Denmark

 

Outline

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