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How FDA Trains its Investigators to Review CAPA and What You Should Do to Prepare - Webinar By GlobalCompliancePanel

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How FDA Trains its Investigators to Review CAPA and What You Should Do to Prepare - Webinar By GlobalCompliancePanel Powered By Docstoc
					                                                                                      Phone: 800-447-9407


                                                                        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
                                                                    Location: Online
credits towards a participant's RAC recertification
upon full completion.                                                  Price : $245.00 (for one participant)


                      Jeff Kasoff
                      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


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   How to prepare for an FDA inspection?
    l   Development and contents of an SOP for FDA
        inspection.
    l   Reliance of FDA inspectors on compliance program
        guide manuals.
    l   Reliance of FDA inspectors on other external
        sources.
    l   Personnel training before inspection.
    l   In depth review and summary of QSIT.
    l   Use of QSIT for internal auditing.



Who Will Benefit:
                                           Suggest a Topic
    l   Executive/Senior
        Management                          More Webinars
    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.


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
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DOCUMENT INFO
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posted:9/14/2012
language:English
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Description: 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.