2-day In-person Seminar on Prepare and Submit 510(k) Premarket Notification Submissions for Success at Minneapolis by globalcompliancepane


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    2-day In-person Seminar on
      Prepare and Submit 510(k) Premarket Notification Submissions for

     Course "Prepare and Submit 510(k) Premarket Notification
     Submissions for Success" has been pre-approved by RAPS as
                                                                                                 Register Now                         
     eligible for up to 12 credits towards a participant's RAC
     recertification upon full completion.

    Date & Time:                                                                           Instructor Profile:

     September 06th and 07th
                                        8 AM to 5 PM EDT
     2012                                                                                               David R. Dills
                                                                                                     Industry Regulatory &
     Duration: 2 Days                   Instructor: David R. Dills                                  Compliance Consultant,

     Location: Minneapolis,
                                        Price : $1295.00   (for one participant)           David R. Dills, an independent
                                                                                           Regulatory & Compliance Consultant
              Register for 4 Participants to Get 1 Free Pass                               with more than 22 years of hands-on
                                                                                           experience and a proven track
                                                                                           record within the FDA regulated
                                                                                           industry, has an extensive
                                                                                           regulatory and compliance
    The majority of medical devices commercialized in the United States                    background with Class I/II/III and
    require a 510(k) submission, which is used to demonstrate that the                     IVD devices and managing and
    medical device is at least as safe and effective, or substantially                     handling activities within the global
    equivalent, to a predicate device, meaning a device that is legally                    regulatory and compliance
    marketed and is not subject to a PMA. Many companies planning to                       landscape. He manages quality,
                                                                                           regulatory and compliance projects
    introduce a medical device to the US market need to submit an
                                                                                           with multiple competing priorities
    application to the FDA called a 510(k). The 510(k) is needed for some
                                                                                           having a direct impact on site
    Class I devices, not all since some are exempt, and nearly all Class II                operations and commercial
    devices and a very small number of Class III devices. This seminar                     opportunities and develops
    will outline all of the critical and key steps involved and provide a                  strategies for governmental approval
    detailed overview of how the FDA 510(k) process works.                                 to introduce new products to market,
                                                                                           provides guidance and direction on
    The Center for Devices and Radiological Health (CDRH) within the FDA                   regulatory and compliance
                                                                                           requirements and prepares/reviews
    receives more than 4,000 (approximately) 510(k) submissions
    annually. Within CDRH, the Office of Device Evaluation (ODE) and the
                                                                                           submissions/dossiers/technical files
    Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD) are                  and addresses requirements in the
    responsible for processing and reviewing 510(k)’s. Branches within                     EU, Pacific Rim and The Americas
    these offices are organized according to medical scientific disciplines                regarding all aspects of device
    and are staffed by FDA reviewers. These reviewers, who are                             commercialization and especially
    biomedical engineers, physicians, microbiologists, chemists, and                       FDA activities. Background
    other professionals, will determine whether a new medical device is                    encompasses broad capabilities in
                                                                                           quality systems, validation,
    substantially equivalent and can be marketed in the United States.
                                                                                           regulatory affairs, GxP compliance,
    Typically, this FDA decision is made within 90 days.
                                                                                           auditing, interfacing with the
                                                                                           regulatory agencies, managing
     Course Outline:                                                                       enforcement actions and mitigating
                                                                                           compliance exposure for companies,
                                                                                           working with Notified Bodies, AR’s
    Course Outline: Day 1:                                                                 and demonstrates credible
                                                                                           experience to maximize business
    Lecture 1:                                                                             performance in the devices arena.
                                                                                           He strives to optimize business
                                                                                           performance through proactive
        l   Introductions/Background
                                                                                           strategies to mitigate compliance
        l   Current trends with the 510(k) process
                                                                                           exposure by providing strategic and
        l   Marketing clearance from CDRH
                                                                                           tactical solutions that facilitate the
        l   Who is Required to Submit a 510(k)                                             achievement of regulatory
        l   When a 510(k) is Not Required                                                  milestones. David has been
        l   Preamendment Devices                                                           previously affiliated with well-known
        l   Locating and justifying the Predicate                                          device manufacturers and service
        l   Substantial Equivalence and demonstration of SE to another                     providers, including a well-known
                                                                                           CRO and has served in various
            legally U.S. marketed device
                                                                                           quality, regulatory and compliance
        l   How to Prepare Submissions and Walk Through the Entire
                                                                                           management and advisory capacities
                                                                                           with increasing responsibilities.
        l   510(k) Submission Methods                                                      David is an accomplished industry
        l   List of forms associated with Premarket Notification 510(k)                    speaker and author of technical and
            submissions                                                                    compliance related topics published
        l   Deciding When to Submit a 510(k) for a Change to an Existing                   in industry journals. Please refer to
            Device - is a new 510(k) required for a modification to your                   his profile provided herein for
                                                                                           additional information about his
                                                                                           background. ...more
        l   What happens if FDA requires additional information and data
         and your responsibilities
     l   Performing a 510(k) assessment to identify or confirm the most
         appropriate predicate device(s) and ensuring that you have             Suggest a Topic         More Webinars
         addressed potential FDA triggers and red-flags
                                                                                   Your Necessity is our Priority
     l   Developing and preparing a written argument for “substantial
         equivalence” that will compare your device to a predicate
     l   Identifying any applicable FDA Guidance Documents
     l   Debrief

 Course Outline: Day 2:

 Lecture 2:

     l   Third-Party Review Program
     l   Communicating directly with FDA staff to identify any special
         requirements that may impact the review of your 510(k), if
     l   Preparing and submitting the 510(k) document to the FDA
     l   FDA requests for more information, clarification and requests
         for more data: how to handle strategically
     l   Coordinating any communications and negotiations with the
         FDA reviewer, and preparing responses to FDA questions, if
     l   Log-In Procedure to check on status
     l   Reviewer Assignment
     l   Review Fees
     l   Decision Letter Issued
     l   Group discussion and review of recent 510(k) clearances and
         proposals and recommendations between FDA and industry
     l   Discussion Points and FDA Trends
     l   Execute an effective path to approval for future submissions
     l   Analyze the benefits/risks for informed decision-making and
         interpreting the regulatory precedents and new legislation
         with the 510(k) process
     l   510(k) Frequently Asked Questions, Q&A, Wrap-Up and
     l   Attendees and participants should be prepared to address any
         issues and challenges as experienced on behalf of their
         company in this open-forum and interactive session

 Click here to register for this seminar

  Who Will Benefit:

     l   Professionals in R&D
     l   Quality Assurance and quality control
     l   Production
     l   Operations
     l   Engineering
     l   Compliance
     l   Regulatory Affairs and all Levels of Management

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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