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Seminar on Auditing Analytical Laboratories for FDA Compliance  


Global Compliance Panel

Seminar on Auditing Analytical Laboratories for FDA Compliance seminar agenda print utility



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


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Seminar Summary:

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Training Course Syllabus:

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

Lecture 1:
GMP Regulations that Apply to Analytical Laboratories

Lecture 2:
Reviewing Documentation

Lecture 3:
Advance Preparation for the Audit

Lecture 4:
Auditing Styles and Structures

Day 2 Schedule

Lecture 1:
Equipment and Laboratory Instrument Qualification

Lecture 2:
What to look for while doing a Walk-Through

Lecture 3:
Other Regulations and Standards, including ISO 17025

Lecture 4:
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.

Seminar Summary:

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