Auditing Analytical Laboratories for FDA Compliance - Webinar by GlobalCompliancePanel

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Auditing Analytical Laboratories for FDA Compliance - Webinar by GlobalCompliancePanel

Website http://bit.ly/1hY9PVi | Edit Freely

Category Seminar, Health, Medical, Pharma, Clinical

Deadline: November 06, 2013 | Date: November 06, 2013

Venue/Country: USA, U.S.A

Updated: 2013-10-17 15:37:46 (GMT+9)

Call For Papers - CFP

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.

This presentation will discuss what advance preparation is needed on the part of the auditor, and discuss what the auditor should look for during the audit. Since documentation is often an issue, a discussion of documentation problems will be presented.

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

Who Will Benefit:This webinar will be of benefit to company auditors who need to investigate the qualifications of contract testing laboratories and internal testing facilities. It will also be beneficial to workers in laboratories that will be audited or inspected by external parties. Personnel from companies that perform testing on small molecule drugs, biologicals, and nutraceuticals will benefit from knowing what standards are being applied to them.

The following specific types of workers will benefit from this webinar:

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

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 .

NetZealous LLC,

DBA GlobalCompliancePanel

161 Mission Falls Lane,

Suite 216, Fremont, CA 94539, USA

USA Phone:800-447-9407

Fax: 302-288-6884

webinarsglobalcompliancepanel.com

http://www.globalcompliancepanel.com

Event Link - http://bit.ly/1hY9PVi

Keywords: Accepted papers list. Acceptance Rate. EI Compendex. Engineering Index. ISTP index. ISI index. Impact Factor.
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