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 : support@compliance4All.com

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

Website

Description

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.


 


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


Consultants


 


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


Email: support@compliance4All.com

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
Email: support@compliance4All.com
Website: http://www.compliance4all.com/


Event Categories: Health & Nutrition.




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