Design History Files (DHF), Device Master Records (DMR), Device History Records (DHR) -The Requi

Products made in the US have to meet global product design documentation specifications.

Fremont, CA (prHWY.com) February 26, 2013 - Description:
This webinar is about the existing and proposed requirements for the US FDA's Device History File (DHF), the Device Master File (DMR), Device History Record (DHR), and 21CFR 820.30 (j), the last of these with all its derivative documents, according to the Current Good Manufacturing Practices (CGMP's).

Products made in the US have to meet global product design documentation specifications. US medical device companies have to meet these different requirements if they need to find a place for themselves in the global medical devices market. Of particular interest are the European Union's MDD TF/DD requirements. This webinar will offer details of these requirements and evaluate the documents' differing purposes or goals, as well as these two different device classification schemes. During this session, the Expert will discuss the necessary and desirable contents relating to the above.

This webinar will cover the following areas:
o The EU's MDD and the Technical File/Design Dossier
o Device Classification -U.S. FDA vs. EU MDD
o Design Control 'Over Time' vs. a Product's 'Snapshot in Time' -Differing Philosophies
o DHF "Typical" Contents and Deliverables
o The DMR and DHR/ Lot/Batch Record
o TF/DD Required Contents
o Parallel Approaches to Documentation -Teams
o FDA and NB Audit Focus
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When: March 6, 10:00 AM PDT | 01:00 PM EDT
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By whom:
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, worldwide.
John has also managed pilot production, regulatory affairs, product development/design control, 510(K) submissions, risk management per ISO 14971, and projects; with over 28 years of experience in the FDA-regulated medical products industry - working with start-ups to Fortune 100 companies, including Abbott Laboratories, Hospira, Tyco/Mallinckrodt. He is a graduate of UCLA.
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For whom:
o Senior management in Drugs, Devices, Biologics, Dietary Supplements
o QA
o RA
o R&D
o Engineering
o Production
o Operations
o Marketing
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Duration: 90 minutes
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To enroll for this webinar, contact
Phone: 800-447-9407

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Tag Words: fda training, regulatory compliance, complaince training, medical device training, pharmaceutical compliance, pharmaceutical training

Categories: Health

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