GlobalCompliancePanelto organize RAPS pre-approved webinar on "The DHF, DMR, DHR, and the Technical File-Design Dossier - USFDA and EU MDD Requirements"
GlobalCompliancePanel, a leading regulatory and compliance continuing education training provider, will be organizing a RAPS pre-approved webinar on the topic, "The DHF, DMR, DHR, and the Technical File-Design Dossier -USFDA and EU MDD Requirements" on November 14.
- Washington, DC-MD-VA-WV (1888PressRelease) November 14, 2012 - As US medical device companies seek to sell globally; they need to be abreast of not just the latest technologies, but also regulatory, legal requirements of the markets they plan to enter. They need to be aware of what the Medical Device Directory (MDD), the EU's regulatory authority, expects in terms of requirements of the DHF, DMR, DHR, and the Technical File-Design Dossier.
This webinar will focus on the existing and proposed requirements for the FDA's DHF, including its derivative documents, the DMR and DHR. It will also take up the MDD's Technical File and Design Dossier requirements and compare and contrast their differing purposes, goals and requirements with those of the FDA.
These are the areas covered in the session:
o The U.S. FDA's DHF
o The EU's MDD and the Technical File/Design Dossier
o Device Classification -U.S. FDA vs. EU MDD
o Design Control vs. a Product 'Snapshot in Time'
o DHF "Typical" Contents
o The DMR and DHR/Lot/Batch Record
o TF/DD Expected Contents
o Parallel Approaches to Documentation -Teams
o FDA and NB Audit Focus
When:November 14, 10:00 AM PDT | 01:00 PM EDT
By whom:
John E. Lincoln, a graduate of UCLA, is a medical device and Regulatory Affairs consultant. He has helped companies to implement or modify their GMP systems and procedures, product risk management and 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 have been described in peer-reviewed technical articles and workshops worldwide.
John has also managed pilot production, regulatory affairs, product development/design control, 510(k) submissions and risk management per ISO 14971 and implemented projects. With over 28 years of experience in the FDA-regulated medical products industry, he has worked from start-ups to Fortune 100 companies, including Abbott Laboratories, Hospira, and Tyco/Mallinckrodt.
For whom:
The webinar will benefit
o Senior Management in Drugs, Devices, Biologics, Dietary Supplements
o QA
o RA
o R&D
o Engineering
o Production
o Operations
o Marketing
Duration:90 minutes
To enroll for this webinar, contact
webinars ( @ ) globalcompliancepanel dot com
Phone: 800-447-9407
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