RAPS Approved Webinar on
How FDA Trains its Investigators to Review CAPA and What You Should Do to Prepare Date: Thursday, October 25, 2012
Time: 10:00 AM PDT | 01:00 PM EDT
Course "How FDA Trains its Investigators to Review CAPA and What You Should Do to Prepare" has been pre-approved by RAPS as eligible for up to 1.00 credits towards a participant's RAC recertification upon full completion.
Duration: 60 Minutes Instructor: Jeff Kasoff Location: Online Price : $245.00 (for one participant)
Jeff Kasoff Director of Regulatory Affairs, Life-Tech, Inc
Jeff Kasoff, RAC, is the Director of Quality at Byrne Medical, a leading manufacturer of endoscopy and colonoscopy devices, where he oversees the operation of the quality system. In this position, ...more
Overview: This webinar will provide valuable assistance to all companies that market in the U.S., since they are by definition subject to FDA regulation, in the Medical Device, Diagnostic, Pharmaceutical, and Biologics fields. This session will discuss what the FDA tells their inspectors, and how they train them, including a detailed analysis of the CAPA training. Also contained in this session will be a section-by-section summary of the QSIT, the document by which FDA inspectors operate during an inspection, as well as how your company can use that same document in your preparation.
Areas Covered in the Session: l l
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How to prepare for an FDA inspection? Development and contents of an SOP for FDA inspection. Reliance of FDA inspectors on compliance program guide manuals. Reliance of FDA inspectors on other external sources. Personnel training before inspection. In depth review and summary of QSIT. Use of QSIT for internal auditing.
Who Will Benefit: Suggest a Topic l
Management Regulatory Management QA Management
Any personnel who may have direct interaction with FDA officials
Consultants Quality System Auditors
Click here to register for this webinar
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
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Published on Sep 13, 2012
This webinar will provide valuable assistance to all companies that market in the U.S., since they are by definition subject to FDA regulati...