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Product Risk Management Under ISO 14971 and FDA-ICH Q9

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Expectations for meaningful hazard analysis, hazardous conditions, and documentation have always existed by regulatory agencies.

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    Live Webinar           on
 
      Product Risk Management Under ISO 14971 and FDA-ICH Q9

    Date & Time:                                                                                                                        

     Wednesday, February 08, 2012         10:00 AM PST | 01:00 PM EST
                                                                                                   Register Now                         
     Duration: 90 Minutes                 Instructor: John E Lincoln

     Location: Online                     Price : $245.00   (for one participant)

                                                                                             Instructor Profile:

     Overview:
                                                                                                          John E Lincoln
    Expectations for meaningful hazard analysis, hazardous conditions,                               Consultant, Medical device
    and documentation have always existed by regulatory agencies.                                      and Regulatory Affairs


    There is an increased awareness of the importance of design                              John E. Lincoln is a medical device
    activities to support the production of safe and effective product.                      and regulatory affairs consultant. He
    Product risk management is a required tool to drive and direct                           has helped companies to implement
    resource constrained product design, manufacture and validation                          or modify their GMP systems and
                                                                                             procedures, product risk
    activities in the company. High-profile field problems indicate that
                                                                                             management, U.S. FDA responses.
    such activities are not yet adequately planned executed, and
                                                                                             In addition, he has successfully
    visibility maintained. There is a failure to fully utilize the power of                  designed, written and run all types of
    current risk management tools. Effective use of such risk                                process, equipment and software
    management tools can help address the growing push by the public                         qualifications/validations, which have
    and the FDA, to "toughen" its approach to product clearance and                          passed FDA audit or submission
    approval, while reducing liability issues.                                               scrutiny, and described in peer-
                                                                                             reviewed technical articles, and
                                                                                             workshops, world wide. John has
     Areas Covered in the Session:                                                           also managed pilot production,
                                                                                             regulatory affairs, product
                                                                                             development/design control, 510(k)
        l   The Revised ISO 14971:2007/9 for Devices
                                                                                             submissions, risk management per
        l   ICH Q9 for Pharma
                                                                                             ISO 14971, and projects; with over
        l   Product Hazard Analysis                                                          28 years of experience in the FDA-
        l   Design, Process, and Use[r] Failure Mode, Effects and Criticality                regulated medical products industry
            Analysis                                                                         - working with start-ups to Fortune
        l   Fault Tree Analysis                                                              100 companies, including Abbott
        l   Suggested Risk Management File / Report, FMECA, FTA                              Laboratories, Hospira,
                                                                                             Tyco/Mallinckrodt. He is a graduate
            Templates
                                                                                             of UCLA. ...more
        l   The Team and It's Involvement – Who, When and How
        l   Using the Completed Document – It's Real Value "In the Loop"


    Click here to register for this webinar                                                 Suggest a Topic       More Webinars

                                                                                              Your Necessity is our Priority
     Who Will Benefit:


        l   Senior Management in Drugs, Devices, Biologics, Dietary
            Supplements
        l   QA                                                                                                 
        l   RA
        l   R&D
        l   Engineering
        l   Production
        l   Operations
        l   Consultants; others tasked with project leadership
            responsibilities



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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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