Design History Files (DHF), Device Master Records (DMR), Device History Records (DHR), Technical Files , Design Dossiers - The Requirements

Overview:

It will also consider the European Union's MDD TF/DD requirements, and evaluate the documents' differing purposes / goals, as well as the two different device classification schemes. Required and desirable contents will be discussed.

Also considered: Areas requiring frequent re-evaluation / update; Similarities and differences; Future trends; Typical DHF Table of Contents; Technical File or Design Dossier Table of Contents; The importance and usefulness of the "Essential Requirements"; Structure of the "Declaration of Conformity"; self-declaring or N-B reviewed; Parallel approaches to development. Finally, the differing approaches to file audits by the FDA and the Notified Body will be discussed.

Why you should Attend: One of our most popular webinars, continuously updated with the latest U.S. FDA and European Union requirements. As U.S. companies go global, they must meet different product design documentation. The cGMPs mandate Design Control and the Design History File (DHF). 
Areas Covered in the Session:

• The EU's MDD and the Technical File / Design Dossier
• Device Classification - U.S. FDA vs. EU MDD
• Design Control 'Over Time' vs. a Product's 'Snapshot in Time' - Differing Philosophies
• DHF "Typical" Contents and Deliverables
• The DMR and DHR / Lot / Batch Record
• TF / DD Required Contents
• Parallel Approaches to Documentation - Teams
• FDA and NB Audit Focus

Who Will Benefit:

• Senior Management in Drugs, Devices, Biologics, Dietary Supplements
• QA
• RA
• R&D
• Engineering
• Production
• Operations
• Marketing

Speaker 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.

Event link:

https://www.compliance4all.com/webinar/-502966LIVE?channel=eventsget-May_2020_SEO

Contact Info

Netzealous LLC, DBA -Compliance4all

Email: [email protected]

Phone: +1-800-447-9407

Website: https://www.compliance4all.com/

Others Details

Contact Info Netzealous LLC, DBA -Compliance4all Email: [email protected] Phone: +1-800-447-9407 Website: https://www.compliance4all.com/