S-04. GMP Compliance Auditing

Course Description

Although quality and compliance auditing is not specifically required by FDA drug GMPs, it has been an integral element of many pharmaceutical operations. The FDA has always expected self-audit programs and has criticized companies for failing to conduct such audits. This course will discuss some of the practical and proven techniques for conducting effective audits of various pharmaceutical operations, to identify the critical deficiencies associated with GMP compliance and product quality.

Learning Objectives

Attendees will gain practical knowledge in establishing an effective GMP compliance audit program and auditor training program. They will learn practical skills for conducting GMP compliance audits, and know “what to look for” when conducting audits of various pharmaceutical operations. They will be familiar with the audit tools that are available to them. Attendees will also have a chance to review and discuss current GMP compliance issues.

Who Should Attend

This course is intended for professionals who are responsible for GMP compliance and auditing, at both the beginner and advanced levels. Production and Quality professionals will benefit by learning the potential problem areas so that appropriate actions can be taken. Regulatory professionals who are responsible for FDA inspections and contact should also attend.

Course Outline

  • Compliance Audit Program
  • FDA/GMP Requirements and Audit Focus for Contractors
  • Auditor Training and Audit Tools
  • General Compliance Auditing
    • Raw material control
    • Weighing and dispensing
    • Manufacturing controls
    • Packaging and labeling controls
    • Calibration and maintenance programs
    • Quality Assurance programs
  • Auditing Chemical/Biological APIs
  • Auditing Validation and Qualification Studies
  • Auditing Purified Water Systems

Approx Time: 2 days
Level: A
Instructor: John Y. Lee

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