Combination Products: FDA's Proposed Rule for GMP Requirements and Introduction and Expectations for "Combo" Products by davidross759


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         Date : Thursday, July 28, 2011
                                                     Live Webinar
         Time : 10:00 AM PDT | 01:00 PM EDT
                                                     Combination Products: FDA's Proposed
     Duration : 60 Minutes                           Rule for GMP Requirements and
                                                     Introduction and Expectations for
        Price : $245.00
                                                     "Combo" Products
      Overview: This webinar will provide valuable assistance and                                                                  
      guidance to device companies in involved in commercialization
                                                                                          Register Now
      of combination products.
                                                                                  Instructor Profile:
      What is a combination product? What are some examples of
                                                                                           David R. Dills
      combination products? How are combination products
                                                                                           Industry Regulatory &
      assigned for review? Where can I find guidance for how                               Compliance Consultant
      master files can be used in the submission of information
                                                                               David R. Dills, an independent
      relevant to my combination product? Determine which Center
                                                                               Regulatory & Compliance Consultant
      will review my combination or non-combination product?
                                                                               with more than 22 years of hands-on
      These topics and more will be addressed during this Webinar,
                                                                               experience and a proven track
      including recently FDA's proposed rule to codify the current
                                                                               record within the FDA regulated
      good manufacturing practice (cGMP) requirements applicable
                                                                               industry, has an extensive
      to combination products.
                                                                               regulatory and compliance
                                                                               background with Class I/II/III and
      Areas Covered in the Session:
                                                                               IVD devices and managing and
                                                                               handling activities within the global
        l    Introduction to Combination Products if you design,               regulatory and compliance
             develop, produce, distribute and deploying a                      landscape. He manages quality,
             sustainable regulatory strategy                                   regulatory and compliance projects
        l    Description and explanation of FDA's proposed rule                with multiple competing priorities
        l    Requirements for Single-Entity and Co-Packaged                    having a direct impact on site
             Combination Products                                              operations and commercial
        l    Identify requirements that apply to the constituent               opportunities and develops
             parts of a Combination Product before they are
                                                                               strategies for governmental approval            
             combined, or packaged together                                    to introduce new products to market,
        l    What current good manufacturing practice                          provides guidance and direction on
             requirements apply to my combination product?                     regulatory and compliance
        l    Learn FDA's new terms and phrases                                 requirements and prepares/reviews
        l    Understand how to address a Request for Designation               worldwide
             for a combination or non-combination product and                  submissions/dossiers/technical files
             examples of “combo” products                                      and addresses requirements in the
        l    Resources and guidance to help define a proven                    EU, Pacific Rim and The Americas
             regulatory strategy                                               regarding all aspects of device
                                                                               commercialization and especially FDA
      Click here to register for this webinar                                  activities. Background encompasses
                                                                               broad capabilities in quality systems,
      Who Will Benefit:                                                        validation, regulatory affairs, GxP
                                                                               compliance, auditing, interfacing with
        l    All levels of management and departmental                         the regulatory agencies, managing
             representatives and those who desire a better                     enforcement actions and mitigating
             understanding or a "refresh" overview                             compliance exposure for companies,
        l    Regulatory Affairs                                                working with Notified Bodies, AR’s
        l    Clinical Affairs                                                  and demonstrates credible
        l    Quality and Compliance                                            experience to maximize business
        l    Marketing & Sales                                                 performance in the devices arena.
        l    Distributors                                                      ...more
        l    Engineering/Technical Services/Operations                            Related Products
        l    Consultants
                                                                                  ISO 13485 Gap Analysis Toolkit

                                                                                  ISO 13485 Quality Manual
                                                                                  Intro to ISO 13485 Presentation

                                                                                  ISO 13485 Internal Auditor Checklist

                                                                                     Your Necessity is our Priority

      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,
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