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Medical Devices: EU Directives, Guidance Documents, CE Marking Process and ISO Certification Programs

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Medical Devices: EU Directives, Guidance Documents, CE Marking Process and ISO Certification Programs Powered By Docstoc
					Live Webinar on : Medical Devices: EU Directives, Guidance Documents, CE Marking
Process and ISO Certification Programs Monday, June 04, 2012 duration : 01:00 to 02:30
PM EST



                                      Description


                                      This webinar is focused on understanding
                                      the requirements of the Medical Device
Get 15 % Discount as a early bird
                                      Directives, their linkage to the EU Clinical
registrations. Use Promo Key :
                                      Trial Directive and the requirements of CE
 CGO15
                                      Marking and ISO Certification on
                                      commercializing products. The course covers
Who will benefit
                                      all relevant topics in brief associated with
                                      the Directives and Guidance Documents, the
                                      reasons behind their introduction and a
This workshop will be of great        review of methods for effective
value to Medical Device               implementation.
professionals and those involved
                                       Areas Covered in the Session:
in the registration of Medical
Devices across the EU. It is
primarily designed to benefit the            - The current regulatory situation in
following disciplines:                        relation to Medical Devices in the EU.
                                             The purpose of the Medical Device
                                              Directives.
      Clinical research and
                                             Meeting the New Requirements for
       medical operations
                                              Conformity Assessment by Product Type.
      Project Managers
                                             Understanding the impact the Directive
      Product Development
                                              will have on developing and marketing
       personnel
                                              new Medical Device products.
      Manufacturing personnel
                                             An overview of key areas of the Directive:
      Researchers managing
                                                  o Scope of application and definition
       Medical Device R&D and
                                                  o Essential Device Requirements
       Development
                                                  o Medical Device Type & Process Path
      Quality Assurance such as
                                                  o Medical Device Technical File
       GMP, GCP Auditors
                                                  o Clinical Investigation Requirements
      Regulatory affairs
         Clinical trial supply                       o  Clinical Evaluations
          personnel                                   o  Notified Bodies involvement
         CRO personnel                          Gain a detailed understanding of all
                                                  Guidance Documents available to assist in
All personnel who need to                         the implementation of these directives.
understand the procedures and
impact of placing Medical Devices        . Learning Objectives
on the Market in the EU (30
expanded EEA countries)                  Upon completion of this course attendees will have
                                         a thorough knowledge of the requirements for
                                         developing and marketing Medical Devices across
                                         the European Union. The Directives are complex
                                         and the requirements differ somewhat by Member
                                         State. The content of this course is designed to
                                         simplify the understanding of all requirements and
                                         to provide attendees with the latest information
                                         regarding interpretation and enforcement of these
Pricing
                                         regulations.

                                         Key Topics to be Discussed:
Live ( Single registration ) : $189.00
Group ( Max 10 Attendee): $249.00        In 2010 under CDRH, CDER and CBER divisions alone,
On Demand (Recording available):$289     FDA classified 1,097 Sponsor, Site and IRB Inspections.
Get Training CD : $499                   Of those Inspections 9% or ~ 66 of the Clinical
                                         Investigator Inspections, 6% or ~ 15 of the IRB
                                         Inspections and 12% or ~ 15 of the Sponsor/Monitor
                                         Inspections were categorized as "Official Action
                                         Indicated". 45% of Clinical Investigator, 50% of IRB and
                                         38% of Sponsor/Monitor Inspections were categorized
                                         as "Voluntary Action Indicated" being required.
More Trainings                           Because FDA Inspections are part of doing business and
                                         getting products to market, Clinical Investigators,
                                         Sponsors and IRBs should not only be prepared to
                                         handle an FDA Inspection but also be prepared to
                                         follow-up on findings, following the inspection.

                                         About Speaker

                                         Robert J. Russell, is President and CEO of RJR Consulting,
                                         Inc, a leading Global Regulatory Consulting firm focusing on
                                         assisting the Life Science Industry. Prior to founding the firm
                                         in 2000, Mr. Russell had over 27 years of experience in CMC,
                                         Global Business Development and Regulatory Compliance for
                                         pharmaceuticals, biologics, medical devices and combination
                                         products. The company has an office in Brussels, Belgium
                                         where they interact with the European Commission and the
                                     Competent Authorities across the EU. Country establishment,
                                     marketing authorizations, variations and license renewals are
                                     core competencies of the course director. Mr. Russell has
                                     received a B.S. and M.S.in Chemistry..

https://compliance2go.com/index.php?option=com_training&speakerkey=11&productKey=21

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