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 Duration: 60 Minutes
CAPA and What You Should Do to Prepare" has been
Instructor: Jeff Kasoff
pre-approved by RAPS as eligible for up to 1.00
credits towards a participant's RAC recertification
upon full completion. Price : $245.00 (for one participant)
Director of Regulatory Register Now
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
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
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 How to prepare for an FDA inspection?
l Development and contents of an SOP for FDA
l Reliance of FDA inspectors on compliance program
l Reliance of FDA inspectors on other external
l Personnel training before inspection.
l In depth review and summary of QSIT.
l Use of QSIT for internal auditing.
Who Will Benefit:
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l Regulatory Management
l QA Management
l Any personnel who may
have direct interaction
with FDA officials Click here to
l Consultants register for this
l Quality System Auditors 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.
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