Auditing Analytical Laboratories for FDA Compliance
Course "Auditing Analytical Laboratories for FDA Compliance" has been pre-approved by RAPS as eligible for up to 1.5 credits towards a participant's RAC recertification upon full completion.
Date & Time: Tuesday, June 5, 2012
10:00 AM PDT | 01:00 PM EDT
Duration: 90 Minutes
Instructor: Steven S Kuwahara
Price : $245.00
Instructor Profile: Steven S Kuwahara Founder & Principal, GXP Biotechnology, LLC
(for one participant)
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 . Steve has participated in the development of drugs and biologicals through all phases of clinical research and final product production. ...more
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: l l l l l l l l
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
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Click here to register for this webinar 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: l l
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
It would be really nice if you can circulate this mail to all your deserving colleagues who can immensely benefit from this program. For more information, please contact the event coordinator. We look forward to seeing you at the webinar. Best regards, Event-coordinator GlobalCompliancePanel
About GlobalCompliancePanel GlobalCompliancePanel is an online knowledge fulfillment community portal & it has put together a new model for online compliance training by creating a single window of learning opportunities for compliance professionals & providing a forum for expert speakers/panelists to render their services through simplified online training delivery mechanisms. Our commitment is give compliance regulatory training, showcasing of best industry practices & quality enrichment training sessions in a most cost effective manner. Compliance professionals can benefit from a wide range of training sessions, giving a diverse choice of events & all sessions being either Live or recorded stream or in the form of audio CDs. GlobalCompliancePanel portal ensures a secure & cost effective online environment and also support your E-learning and development on/through our website. Keep track of all webinars arranged for your industry through notifications & event calendars being mailed to your inbox. GlobalCompliancePanel opens new doors of learning opportunities for professionals. GlobalCompliancePanel www.globalcompliancepanel.com 1000 N West Street Suite, 1200 Wilmington DE 19801 Phone: 800-447-9407 or Fax your PO to: 302-288-6884 If you do not wish to receive this training alerts from GlobalCompliancePanel Click Unsubscribe
Published on May 17, 2012
Auditing analytical laboratories can be complex because of the preparation that is often required. All of the GMP rules do not apply to the...