S-06. GMP Compliance for Quality Control Laboratory Operations

Course Description

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.

Who Should Attend

This course is intended for the Quality Control, Quality Assurance and Compliance professionals who are directly involved with laboratory operations, or responsible for the compliance and auditing of laboratory systems and controls. The information in this course may be beneficial for Regulatory Affairs professionals who are responsible for FDA submissions.

Course Outline

  • USP Interpretations
  • Laboratory Walk-through Inspection Coverage
  • General GMP Requirements and Laboratory Controls
    • Samples, reagents and reference standards
    • Instrument calibration, maintenance, qualification and logbooks
    • Investigations and change control
    • Personnel qualification and training
    • Stability program
    • Raw material reduced testing program
    • Retention sample program
  • Microbiology Laboratory Controls
    • Media control and media growth promotion, sterility testing, methods validation
  • Laboratory Procedures and Documentation
    • SOPs, raw data, electronic records
  • Laboratory Data Integrity
  • Analytical Methods Validation
  • Laboratory OOS: Investigation and Retesting