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Webinar On - Key Regulatory Documents: Design History File (DHF), Device Master Record (DMR), Device

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(Free Press Release) Compliance Trainings focuses on providing regulatory and quality web based online trainings to industry professionals across the globe. Compliance Trainings strives to educate and enhance the knowledge and broaden the horizons of regulatory professionals as well as professionals from the HR, Healthcare and many other industries. Regulatory compliance solutions from the house of Compliance Trainings strictly meet international standards and are fundamentally based on the objective of bringing down client compliance costs. Internationally scalable solutions are fully integrated into every webinar or event and help clients meet stringent demands of GxP, ISO and FDA regulatory authorities.

Webinar On - Key Regulatory Documents: Design History File (DHF), Device Master Record (DMR), Device


      

Scheduled On : Wednesday, February 26, 2014 at 13:00 Hrs

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.

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Webinar On - Key Regulatory Documents: Design History File (DHF), Device Master Record (DMR), Device

Source: Press Release

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