The DHF, Technical File and Design Dossier - Similarities, Differences and the Future 2018

  • 2018
  • Embassy Suites Las Vegas, NV, United States

Description

The DHF, Technical File and Design Dossier - Similarities, Differences and the Future 2018 is a seminar that provides knowledge on Medical Device documentation requirements and implementation, including:

  • Device Master Records
  • Device History Files
  • Technical Files / Design Dossiers, documents, activities / plan(s)
  • Device History Records

Topics covered:

  • The Design History File - documenting Product Design Control and its nine elements
  • The Design Control requirements of the CGMPs, 21 CFR 820.30
  • Summary of morning discussion
  • The Device Master Record and the Device History Record
  • Review of group activity and Q&A
  • Group activity on the 1) The DHF, or 2) The DMR and DHRs
  • The "Essential Requirements" and their documentation
  • The EU`s Medical Device Directive
  • ISO 14971:2012, The Product Risk Management File / Report overview
  • The remaining elements of a Technical File / Design Dossier
  • DHF / TF, DD Trends
  • Review of group activity and Q&A
  • Group activity on 1) The Technical File / Design Dossier, or 2) Essential Requirements

The DHF, Technical File and Design Dossier - Similarities, Differences and the Future 2018 brings together attendees from medical device regulated companies, including:

  • Regulatory Affairs
  • Senior and middle management and staff
  • R&D
  • QA/QC
  • Manufacturing Engineers
  • Production Management
  • Project Managers
  • Process Engineers
  • Anyone involved in medical device development, documentation, and regulatory responsibilities
  • Vendors, sales and marketing

Past Events

Important

Please, check "The DHF, Technical File and Design Dossier - Similarities, Differences and the Future" official website for possible changes, before making any traveling arrangements

Event Categories

Business: Internal Audit & Compliance
Health & Medicine: Medical device, Pharma

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