Design Controls - Requirements for Medical Device Developers from GlobalCompliancePanel

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                                                                        RAPS Approved Webinar on


Design Controls - Requirements for Medical Device Developers

Date: Wednesday, December 12, 2012                                      Time: 10:00 AM PST | 01:00 PM EST


Course "Design Controls - Requirements for Medical Duration:                    90 Minutes
Device Developers" has been pre-approved by RAPS
                                                        Instructor:             John E Lincoln
as eligible for up to 1.5 credits towards a
participant's RAC recertification upon full completion. Location:               Online


                    John E Lincoln
                    Consultant, Medical device and                          Register Now
                    Regulatory affairs,

John E. Lincoln is a medical device and regulatory affairs consultant. He has helped companies to
implement or modify their GMP systems and procedures, product risk management, U.S. FDA responses.
...more

Overview:
This webinar will discuss the 9 required elements of a Design Control System. It will consider
different methods of implementation, and expectations of the U.S. FDA, proven by documentation.


Such an analysis takes on added urgency as a result of the stated intent of the Agency to get
tougher across the board in its expectations for the medical industry and what it (the FDA and
industry) need to do to "toughen" the safety and efficacy of medical devices.

Areas Covered in the Session:

    l   FDA Device Clearance - Changes in Direction
    l   Current Design Control Requirements
    l   Defining the "Start" Date and Its Significance
    l   The 9 Design Control Elements and Their
        Implementation and Documentation
    l   Their Implementation and Documentation
    l   "Retroactive" Design Control
    l   The Business Case for Design Control



Who Will Benefit:

    l   Senior management in               Suggest a Topic
        Devices and Combo
                                           More Webinars
        Products
    l   QA
    l   RA
    l   R&D
    l   Engineering                        Click here to
    l   Production
                                         register for this
    l   Operations
    l   Consultants                           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


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