Compiling the Design History File, and Technical File / Design Dossier - Webinar by GlobalCompliancePanel 2010
September 22, 2010(Ended)
Online Webinar
This webinar will examine both the FDA and MDD regulatory
expectations for the respective DHF and TF / DD. It will discuss the
major sections of both, common elements and differences, what must be
included and what should be included, and how the information should be
compiled and presented. Major modules of a DHF SOP and a TF / DD SOP
will be presented and discussed -- the webinar will address the
development of a new, or revision of an existing DHF SOP and TF / DD to
ensure they meet regulatory expectations and assist those charged with
compiling, updating and/or revising these mandatory documents.C15Why should you attend: The U.S. FDA implemented Design Control requirements in 1996/97, and yet continues to find problems in the key design control document, the Design History File (DHF). Yet this drives the Device Master Record as well as providing major support for the EU MDD`s Technical File / Design Dossier. What are the FDA expectations for the DHF under Design Control? What are the EU MDD / Notified Body`s expectations for the complementary TF / DD? How are they similar? What are the important differences? In what ways are they moving together under Harmonization? Evaluate some of the key inputs to both, which should form the basis for SOP`s explaining the development of each.
Prices *
245 US Dollar (Early registration date: September 21, 2010)
Exhibition
No exhibition
Organization
Categories
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- Preparing for FDA Inspections in a Changing Regulatory Environment - Webinar by GlobalCompliancePanel 2010
- The ICF Process: Tips on Achieving Optimal compliance and Comprehension
- Project Management Certification Study Group - Information Year 2010
Important
Please, check the conference website for possible changes, before you make any traveling
arrangements
* Prices are for evaluation only.
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