Product Hazard Analysis and Risk Management Under ISO 14971 and FDA, ICH Q9 - Webinar By GlobalCompliancePanel

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                                                                      RAPS Approved Webinar on


Product Hazard Analysis and Risk Management Under ISO 14971 and
FDA, ICH Q9

Date: Wednesday, November 28, 2012                                    Time: 10:00 AM PST | 01:00 PM EST

Course "Product Hazard Analysis and Risk
Management Under ISO 14971 and FDA, ICH Q9"                   Duration:      90 Minutes
has been pre-approved by RAPS as eligible for up to           Instructor:    John E Lincoln
1.5 credits towards a participant's RAC                       Location:      Online
recertification upon full completion.


                    John E Lincoln
                    Consultant, Medical device                            Register Now
                    and 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 address the procedures, provide and discuss suggested templates, necessary to
develop or modify and then use the ISO 14971 and Q9 models to perform and document such
activities for any medical product. It will examine the additional actions necessary to make it a
useful product reference, CAPA, root cause / failure investigation, and validation prioritization, and
training tool, and how to maintain it as a "living document".

Expectations for meaningful hazard analysis, hazardous conditions and the resulting product risk
management documentation have always existed by regulatory agencies. There is an increased
awareness of the importance of design activities to support the production of safe and effective
product. Product risk management is a required tool to drive and direct resource constrained
product design, manufacture and validation activities, as well as CAPA resolution actions, in the
company.


Areas Covered in the Session:

    l   The Revised ISO 14971:2007/9 for Devices
    l   ICH Q9 for Pharma
    l   Product Hazard Analysis
    l   Design, Process, and Use[r] Failure Mode, Effects
        and Criticality Analysis
    l   Fault Tree Analysis
    l   Suggested Risk Management File / Report, FMECA,
        FTA Templates
    l   Why and How to use the ISO 14971 "Model" in all
        Regulated Industries
    l   The Team and It’s Involvement - Who, When and
        How
    l   Using the Completed Document - It's Real Value "In
        the Loop"


Who Will Benefit:

    l   Senior management in             Suggest a Topic
        Drugs, Devices, Biologics,
                                          More Webinars
        Dietary Supplements
    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
About GlobalCompliancePanel
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1200 Wilmington DE 19801

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