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John E. Lincoln



  

299


Key Regulatory Documents: Design History File (DHF), Device Master Record (DMR), Device History Record (DHR) and Technical File (TF) and Design Dossier

Product Id : MD1261       Category : Medical Devices

90 Minutes

Description :

There are key regulatory documents global medical device companies must meet for the U.S. and the European Union / Common Market.  And there are important differences. The cGMPs mandate Design Control and proof of compliance in the Design History File (DHF).  In order to sell globally, the EU's CE-marking documentation is a requirement -- the Technical File or Design Dossier.  Currently they serve different purposes, support different goals, but there are some similarities.  And both are moving together in some important areas.  Being aware of the similarities and differences can further concurrent development / documentation, and/or updates to both.

What are DMRs and DHRs relationship to DHFs, TF/DDs?

This 90 minute webinar will examine the existing and proposed requirements for the U.S. FDA's DHF and the EU MDD's TF/DD. This webinar will provide valuable assistance to all regulated device companies that need to ensure their DHFs, TFs/DDs and associated and derivative documentation meet their respective requirements. It also addresses current requirements as well as some changes on the horizon.

Areas Covered in the Session :
  • How to meet and document their differing requirements.
  • Required and desirable contents.
  • Areas requiring frequent re-evaluation / update.
  • Similarities and differences, and future convergences and trends.
  • Typical DHF contents.
  • Typical Technical File or Design Dossier 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.
  • Where the Device Master Record / Device History Record "tie in".
  • Differing approaches to records audits by the U.S. FDA and an EU Notified Body.

Who Will Benefit:
This webinar will provide valuable assistance to all regulated device companies that need to ensure their DHFs, TFs/DDs and associated and derivative documentation meet their respective requirements. Its principles apply to personnel / companies in the Medical Devices,  Diagnostic, and to a lesser extent the Pharmaceutical and Biologics fields. The employees who will benefit include:
  • Senior management
  • Middle management
  • R&D
  • Engineering
  • Software
  • QA / RA
  • Manufacturing
  • Operations
  • Consultants
  • cGMP instructors
  • All personnel especially involved in device development, regulatory compliance and documentation.
For Live – How it works:
  • Login Information with Password to join the session, 24 hours prior to the webinar
  • Presentation Handout in .pdf format
  • Presentation from the Speaker
  • Q&A session with the Speaker
  • Feedback form
  • Certificate of Attendance
For Recording – What you will receive:
  • Login Information with Password to view the webinar, 24 hours after the Live webinar (link valid for 6 months)
  • Presentation Handout in .pdf format
  • Recorded session of the presentation from the Speaker
  • Feedback form
  • Certificate of Attendance (optional)
Speaker Profile
John E. Lincoln, is Principal of J. E. Lincoln and Associates LLC, a consulting company with over 33 years experience in U.S. FDA-regulated industries, 19 years as a full-time consultant. John has worked with companies from start-up to Fortune 100, in the U.S., Mexico, Canada, France, Germany, Sweden, China and Taiwan. He specializes in quality assurance, regulatory affairs, QMS problem remediation and FDA responses, new / changed product 510(k)s, process / product / equipment including QMS and software validations, ISO 14971 product risk management files / reports, Design Control / Design History Files, Technical Files.

He has held positions in Manufacturing Engineering, QA, QAE, Regulatory Affairs, to the level of Director and VP (R&D). In addition, John has prior experience in military, government, electronics, and aerospace. He has ptublished numerous articles in peer reviewed journals, conducted workshops and webinars worldwide on CGMP subjects. John is a graduate of UCLA.
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