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


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    RAPS Approved Webinar                  on
     FDA Inspections - Do's and Don'ts

    Date & Time:                                                                                                                        

     Course "FDA Inspections - Do's and Don'ts" has been pre-
     approved by RAPS as eligible for up to 1.00 credits towards a
                                                                                                  Register Now                             

     participant's RAC recertification upon full completion.

                                                                                             Instructor Profile:
     Tuesday, September 25, 2012          10:00 AM PDT | 01:00 PM EDT

     Duration: 60 Minutes                 Instructor: Jeff Kasoff                                           Jeff Kasoff
                                                                                                       Director of Regulatory
     Location: Online                     Price : $245.00   (for one participant)
                                                                                                       Affairs, Life-Tech, Inc

                                                                                             Jeff Kasoff, RAC, is the Director of
                                                                                             Quality at Byrne Medical, a leading
    This session will discuss how to prepare for the inspection, what to                     manufacturer of endoscopy and
    d o during the inspection and the close-out interview, and how to                        colonoscopy devices, where he
    respond to the inspection. Also contained in this session will be the                    oversees the operation of the quality
    limits of FDA's scope during an inspection, including what documents                     system. In this position, Jeff is
                                                                                             responsible for oversight of the
    you are not required to show them, and the permissibility of
                                                                                             document control system, including
    photographs and affidavits.
                                                                                             maintenance of regulatory
                                                                                             documentation. Prior to this, Jeff
       l   Does the FDA call in advance or just show up at my door?                          spent 13 years at Life-Tech, Inc. as
       l   Where do I let the inspector go?                                                  the Director of Regulatory Affairs,
       l   Do I give them a tour?                                                            where he was responsible for
       l   What should I let them see?                                                       compliance of the corporate quality
                                                                                             system. Jeff received his regulatory
       l   Who should I let them talk to? Are they ever going to leave?
                                                                                             affairs certification in 1996. ...more

    The FDA inspection is the most nerve-wracking event in the life of a
    regulatory professional - you're in charge of compliance, usually in
    the background, and NOW you're in the spotlight, and if your                            Suggest a Topic       More Webinars
    performance is not good, it is not the show that may close, it is YOUR
                                                                                              Your Necessity is our Priority
    COMPANY! However, adequate planning, training, composure, and
    understanding should result in many encore presentations!

    Areas Covered in the Session:
       l   How to prepare for an FDA inspection
       l   Development and contents of an SOP for FDA inspection
       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

    Click here to register for this webinar

    Who Will Benefit:

       l   Internal / External Auditors
       l   Regulatory Management
       l   Quality Assurance Professionals
       l   Consultants
       l   Sales/Marketing Management
       l   Senior and mid-level Management
       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
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