Top Selling Medical Devices Webinars - Pack of 10 Courses - Webinars By GlobalCompliancePanel

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Top Selling Medical Devices Webinars - Pack of 10 Courses - Webinars By GlobalCompliancePanel Powered By Docstoc
					                                                                                                                       


       of 10 Best Courses
  Pack Selling Medical Devices Webinars - Pack of 10 Courses
  Top
    Actual Price:      $2950.00

    Your Price:        $1495.00    (You Save 50%)
                                                                                        Buy Now

    Course#1
    Device Changes and the 510(k)
    The FDA holds companies responsible for filing new 510(k)s when
    one change is major enough to impact safety / effectiveness, or                      John E Lincoln
    when a series of lesser changes finally reach the "tipping point".               Consultant, Medical device
    This is a major headache.                                                          and Regulatory affairs


    Course#2                                                                  John E. Lincoln is a medical
                                                                             device and regulatory affairs
    The New FDA-Product Approval, Inspection, and
                                                                             consultant. ..more
    Enforcement
    The new commissioner recently announced a new policy for
    Warning Letters and FDA-483 responses, putting manufacturers                            Edwin L Bills
                                                                                     Principal Consultant, Bilanx
    under very tight response timelines.
                                                                                            Consulting LLC

    Course#3                                                                 During his 20 year career in medical
    Design History Files: Their Content and Control                          devices, Mr. Bills has held a number
    After attending this presentation the attendee should come away          of quality and regulatory affairs
    with a good knowledge of what the requirements for Design                positions. ..more
    History Files are from both a domestic and international
    perspective.                                                                          Albert Cefalo
                                                                                    Regulatory Affairs Specialist,
    Course#4                                                                           Analogic Corporation
    FDA's New Enforcement of 21 CFR Part 11
    FDA's new Part 11 regulation takes quite some time, but inspectors       Albert Cefalo, Regulatory Affairs
    g o out and inspect computer systems and e-records for compliance        Specialist, Analogic Corporation.
    with GMPs and most recent Part11 interpretations.                        ..more

    Course#5                                                                            Dr. Ludwig Huber
    Design History File (DHF), Device Master Record                                  Chief Advisor - Global FDA
    (DMR), Device History Record (DHR) and Technical                                    compliance, Agilent
    File (TF) - Regulatory Documents Explained                                              Technologies
    The FDA QSR and the Medical Device Directive specify certain
    documents or records that should be included in your                      Ludwig Huber, Ph.D., is Director
    organization's quality systems - Design History File (DHF), the
                                                                             of Labcompliance and Chief Advisor
                                                                             for global FDA compliance at Agilent
    Device Master Record (DMR) the Device History Record (DHR), and
                                                                             Technologies. ..more
    the Technical File (TF).

    Course#6                                                                                 Jeff Kasoff
                                                                                        Director of Regulatory
    The 510(k) Submission: Requirements, Contents, and
                                                                                        Affairs, Life-Tech, Inc
    Options
    This presentation will provide an understanding of how to get a
                                                                             Jeff Kasoff, RAC, is the Director of
    device requiring a 510(k) submission to market quickly.
                                                                             Regulatory Affairs at Life-Tech, Inc.,
    Course#7                                                                 a leading manufacturer of
                                                                             consumables and instrumentation in
    Complaint Handling in Compliance with FDA and ISO
                                                                             the urodynamic and pain
    Regulations
                                                                             management fields. ..more
    Negative customer feedback about a product’s performance or
    safety is a strong indicator of whether a firm's manufacturing
                                                                                          David R. Dills
    process is in control.                                                             Industry Regulatory &
    Course#8                                                                           Compliance Consultant

    Product Risk Management - ISO 14971:2007
                                                                              David R. Dills, Indpendent
    This webinar will address the use of the ISO 14971 model to
                                                                             Regulatory & Compliance
    perform and document such activities and the additional actions          Consultant, departed PAREXEL
    necessary to make it a useful product reference and training tool.       Consulting in July 2008 due to
    Course#9                                                                 service line organizational change.
                                                                             ..more
    Conducting Successful Product Complaint
    Investigations                                                                        Steven Walfish
    This webinar will provide valuable assistance and guidance to the                   President, Statistical
    life sciences manufacturers engaged in various aspects of product                   Outsourcing Services
    complaint investigations.

    Course#10                                                                 Mr. Steven Walfish is the
                                                                             President of Statistical Outsourcing
    Using Statistics to Determine Sample Size                                Services, a consulting company that
    This webinar covers the statistical methods used to calculate            provides statistical analysis and
    sample sizes for both attribute and variables data.                      training to FDA regulated industries.
                                                                             ..more
Click here to buy the webinar pack
                                                                                    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,
Event-coordinator
GlobalCompliancePanel



About GlobalCompliancePanel
GlobalCompliancePanel is an online knowledge fulfillment community portal & it has put together a new model for online
compliance training by creating a single window of learning opportunities for compliance professionals & providing a
forum for expert speakers/panelists to render their services through simplified online training delivery mechanisms. Our
commitment is give compliance regulatory training, showcasing of best industry practices & quality enrichment training
sessions in a most cost effective manner. Compliance professionals can benefit from a wide range of training sessions,
giving a diverse choice of events & all sessions being either Live or recorded stream or in the form of audio CDs.
GlobalCompliancePanel portal ensures a secure & cost effective online environment and also support your E-learning
and development on/through our website. Keep track of all webinars arranged for your industry through notifications &
event calendars being mailed to your inbox. GlobalCompliancePanel opens new doors of learning opportunities for
professionals.


GlobalCompliancePanel
www.globalcompliancepanel.com
1000 N West Street Suite,
1200 Wilmington DE 19801

Phone: 800-447-9407 or
Fax your PO to: 302-288-6884


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DOCUMENT INFO
Description: Course#1 Device Changes and the 510(k) The FDA holds companies responsible for filing new 510(k)s when one change is major enough to impact safety / effectiveness, or when a series of lesser changes finally reach the "tipping point". This is a major headache. Course#2 The New FDA-Product Approval, Inspection, and Enforcement The new commissioner recently announced a new policy for Warning Letters and FDA-483 responses, putting manufacturers under very tight response timelines. Course#3 Design History Files: Their Content and Control After attending this presentation the attendee should come away with a good knowledge of what the requirements for Design History Files are from both a domestic and international perspective. Course#4 FDA's New Enforcement of 21 CFR Part 11 FDA's new Part 11 regulation takes quite some time, but inspectors go out and inspect computer systems and e-records for compliance with GMPs and most recent Part11 interpretations. Course#5 Design History File (DHF), Device Master Record (DMR), Device History Record (DHR) and Technical File (TF) - Regulatory Documents Explained The FDA QSR and the Medical Device Directive specify certain documents or records that should be included in your organization's quality systems - Design History File (DHF), the Device Master Record (DMR) the Device History Record (DHR), and the Technical File (TF). Course#6 The 510(k) Submission: Requirements, Contents, and Options This presentation will provide an understanding of how to get a device requiring a 510(k) submission to market quickly. Course#7 Complaint Handling in Compliance with FDA and ISO Regulations Negative customer feedback about a product’s performance or safety is a strong indicator of whether a firm's manufacturing process is in control. Course#8 Product Risk Management - ISO 14971:2007 This webinar will address the use of the ISO 14971 model to perform and document such activities and the additional actions necessary to make it a useful product refer