FDA Inspections - Do's and Don'ts - Webinar By GlobalCompliancePanel by globalcompliancepane


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									                                                                       Toll Free Number: 800-447-9407

                                                                        RAPS Approved Webinar on

FDA Inspections - Do's and Don'ts

Date: Tuesday, November 27, 2012                                        Time: 10:00 AM PST | 01:00 PM EST

Course "FDA Inspections - Do's and Don'ts" has been Duration:                   60 Minutes
pre-approved by RAPS as eligible for up to 1.00
                                                    Instructor:                 Jeff Kasoff
credits towards a participant's RAC recertification
upon full completion.                               Location:                   Online

                      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

This session will discuss how to prepare for the inspection, what to do during the inspection and
the close-out interview, and how to respond to the inspection. Also contained in this session will be
the limits of FDA's scope during an inspection, including what documents you are not required to
show them, and the permissibility of photographs and affidavits.

    l   Does the FDA call in advance or just show up at my door?
    l   Where do I let the inspector go?
    l   Do I give them a tour?
    l   What should I let them see?
    l   Who should I let them talk to? Are they ever going to leave?

Areas Covered in the Session:

    l   How to prepare for an FDA inspection
    l   Development and contents of an SOP for FDA
    l   Personnel training before inspection
    l   How to behave during an inspection
    l   What to show FDA during an inspection
    l   Proper Post-inspection Follow-up
    l   Limitations of scope of inspection
    l   Response to investigation findings
    l   FDA guidance documents used by their inspectors

Who Will Benefit:

    l   Internal / External                Suggest a Topic
    l   Regulatory Management              More Webinars
    l   Quality Assurance
    l   Consultants
    l   Sales/Marketing
        Management                         Click here to
    l   Senior and mid-level             register for this
        Management                            webinar
    l   Quality System Auditors

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,

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

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