Auditing Analytical Laboratories for FDA Compliance

Start Date : July 10, 2018
End Date : July 10, 2018
Time : 10:00 am to11:30 am

Phone : 800-447-9407
Email :

Location :
161 Mission Falls Lane, Suite 216, Fremont, CA 94539, USA




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 




Areas Covered in the Session:

GMP Regulations that Apply to Analytical Laboratories

Reviewing Documentation

Advance Preparation for the Audit

Auditing Styles and Structures


Who Will Benefit:

Supervisors and Analysts in Contract Testing Laboratories

Personnel Responsible for Selecting Contract Testing Laboratories



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.


Event Fee: One Dial-in One Attendee Price: US$150.00


Contact Detail:

Compliance4All DBA NetZealous,

Phone: +1-800-447-9407


Organized by

Organized by compliance4all14

Event Manager ,
161 Mission Falls Lane, Suite 216,

Compliance4All is a professional trainings provider for the regulated industries. It offers professional trainings for regulatory compliance professionals and offers innovative strategic consulting and advice to a broad range of organizations. These services help them to be compliant with regulatory requirements.

Tel: 800-447-9407
Mobile: 8004479407

Event Categories: Health & Nutrition.

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