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.
Day 1 Schedule
GMP Regulations that Apply to Analytical Laboratories
Advance Preparation for the Audit
Auditing Styles and Structures
Day 2 Schedule
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
Dr. Steven Kuwahara
Founder & Principal, GXP Biotechnology, LLC
Dr. Steven 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.