Auditing Analytical Laboratories for FDA Compliance

Auditing analytical laboratories can be complex because of the preparation that is often required. All of the GMP rules do not apply to the laboratory; while there may be additional requirements depending upon the type of testing that is being conducted. In many cases, the laboratory itself may not understand what regulations apply to the work that is being conducted.

Areas Covered in the Session:

• GMP Regulations that Apply to Analytical Laboratories
• Reviewing Documentation
• Advance Preparation for the Audit
• Auditing Styles and Structures
• Equipment and Laboratory Instrument Qualification
• What to look for while doing a Walk-Through
• Other Regulations and Standards, including ISO 17025
• Following through on the Audit

• External and Internal Auditors
• Supervisors and Analysts in Quality Control Laboratories and Quality Assurance Groups
• Supervisors and Analysts in Contract Testing Laboratories
• Personnel Responsible for Selecting Contract Testing Laboratories
• Consultants