Human Factors and Design Controls for Medical Devices and Combination Products 2015

  • 30 Sep - 01 Oct, 2015
  • Boston, MA, United States

Description

Human Factors and Design Controls for Medical Devices and Combination Products 2015 covers topics such as:

  • The new draft guidance on CGMP requirements for combination products
  • Office of Combination Products Update
  • The combination product development process
  • Other recent and upcoming guidances and issues
  • Companion diagnostics regulations, guidances, and challenges
  • Clinical evidence development and coordination for combination products
  • Industry assessment of FDA review of combination products
  • FDA assessment of combination product submissions
  • Quality by Design vs. Design Control
  • Aligning pharmaceutical CGMP and device Quality System Regulations
  • Human factors and combination products – paradigm matching
  • Risk management and combination products
  • Combination product inspections
  • Reconciling drug and device postmarket requirements and processes
  • Combination products in a global marketplace

Human Factors and Design Controls for Medical Devices and Combination Products 2015 brings together:

  • Product stewards
  • Drug, device, diagnostics, and biologics regulatory, quality, and clinical professionals involved with combination product development and oversight
  • R&D and product testing professionals
  • Business development executives involved in combination product strategic partnerships
  • Combination product supply chain professionals

Past Events

Important

Please, check "Human Factors and Design Controls for Medical Devices and Combination Products" official website for possible changes, before making any traveling arrangements

Event Categories

Health & Medicine: Medical device

Other Events with Similar Categories

Other Events with Similar Location or Organizer

Featured Conferences & Exhibitions