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How FDA Trains its Investigators to Review CAPA and What You Should Do to Prepare
Date & Time: Tuesday, February 28, 2012
10:00 AM PST | 01:00 PM EST
Duration: 60 Minutes
Instructor: Jeff Kasoff
Location: Online
Price : $245.00
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(for one participant)
Instructor Profile:
Overview:
Jeff Kasoff Director of Regulatory Affairs, Life-Tech, Inc
During an inspection, FDA personnel will take a great deal of time reviewing your company's CAPA system. What will they look for? This session will discuss all the documents used by FDA to train their inspectors to review your CAPA system, some of which you may not b e familiar with. Also contained in this session will be a section-by-section summary of the CAPA subsection 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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Documents Used by FDA Inspectors CAPA Implications of Investigations Operations Manual (IOM), and Recommended Methods of Compliance for each Requirement CAPA Implications of CPG Manual 7382.845, and Recommended Methods of Compliance for each Requirement QSIT Manual: Description of each CAPA Inspectional Objective, and Recommended Methods of Compliance
Jeff Kasoff, RAC, is the Director of Quality at Byrne Medical, a leading manufacturer of endoscopy products. In this position, Jeff is responsible for supplier management, during which he reviews and approves supplier qualification, selection, assessment, and CAPA. Prior to this, Jeff spent 13 years at Life-Tech as the Director of Regulatory Affairs, where he was responsible for regulatory compliance of all aspects of the quality system. Jeff received his regulatory affairs certification in 1996. ...more
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Click here to register for this webinar Who Will Benefit: This webinar will provide valuable assistance to all regulated
companies, since a CAPA program is a requirement across the Medical Device, Diagnostic, Pharmaceutical, and Biologics fields. The employees who will benefit include: l l l l l
R&D Management Regulatory Management QA Management Consultants Quality System Auditors
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