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Auditing Analytical Laboratories for FDA Compliance

Instructor Steven S Kuwahara
Webinar ID 30019
Coming Soon

Date Coming Soon
Time 2:00 PM IST
Duration 90 Minutes  

Overview

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.

Why should you Attend

  • 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

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

Speaker Profile

Steven S. Kuwahara, Ph.D. is the founder and Principal of GXP BioTechnology LLC, a consulting firm that works in the areas covered by the GLP and GMP of drugs, biologics, and nutraceuticals. Steve has over 30 years of experience in supervising quality control laboratories, including an animal testing facility, and in performing GLP and GMP audits of internal and external testing laboratories . Steve has participated in the development of drugs and biologicals through all phases of clinical research and final product production.