Live Webinar
Compiling the Design History File, and Technical File / Design Dossier
Overview:
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.C15
Areas Covered in the Session:
l Design Control and the DHF
l The 9 Key Elements in the DHF
l The DHF/DMR and the MDD's TF / DD
l The 13 Key Elements of the TF / DD
l Differences and Similarities
l High Risk Areas
l Movements Toward Harmonization
l Incorporating These Points Into a Design Control / DHF SOP and
a TF / DD SOP
Click here to register for this webinar
Who Will Benefit:
l Senior management primarily in Devices; some value to Drugs,
Biologics, Dietary Supplements
l QA
l RA
l R&D
l Engineering
l Production
l Operations
Date:
Wednesday, September 22, 2010
Time:
10:00 AM PDT | 01:00 PM EDT
Duration: 60 Minutes
Price:
$245.00
Register Now
Instructor Profile:
John E. Lincoln is a medical device
and regulatory affairs consultant. He
has helped companies to implement
or modify their GMP systems and
procedures, product risk
management, U.S. FDA responses.
In addition, he has successfully
designed, written and run all types of
process, equipment and software
qualifications/validations, which have
passed FDA audit or submission
scrutiny, and described in peer-
reviewed technical articles, and
workshops, world wide. John has
also managed pilot production,
regulatory affairs, product
development/design control, 510(k)
submissions, risk management per
ISO 14971, and projects; with ov