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FDA cGMP: Compliance Auditing

Date: June 15 - 16, 2020
Instructor: Mr. John Y. Lee
Location: Copenhagen, Denmark
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Although quality and compliance auditing is not specifically required by drug GMPs, it has been an integral element of many pharmaceutical operations. The FDA has always been in favor of self-audit programs and has issued citations to companies for failing to conduct audits. This course will discuss some of the practical and proven techniques for conducting effective audits of various pharmaceutical operations.

  • Audit Techniques
  • General Compliance Auditing
    • Raw material control
    • Weighing and dispensing
    • Manufacturing controls
    • Packaging and labeling controls
    • Calibration and maintenance programs
    • Quality Assurance programs
  • Auditing API Operations
  • Auditing Validation and Qualification Studies
  • Auditing Purified Water Systems