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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

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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.

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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.

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Executive/Senior

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Management Regulatory Management QA Management

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Any personnel who may have direct interaction with FDA officials

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Consultants Quality System Auditors

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How FDA Trains its Investigators to Review CAPA and What You Should Do to Prepare