Combination Products: FDA`s Final Rule for GMP Requirements and Introduction and Expectations for `Combo` Products 2015

  • 14 Oct 2015
  • Online Event

Description

Topics
  • FDA`s proposed rule
  • Combination Products if you develop, design, distribute, produce and deploying a sustainable regulatory strategy
  • Identify requirements that apply to the constituent parts of a Combination Product before they are combined, or packaged together
  • Requirements for Single-Entity and Co-Packaged Combination Products
  • FDA`s new terms and phrases
  • Current good manufacturing practice requirements
  • Define a proven regulatory strategy
  • How to address a Request for Designation for a combination or non-combination product
Who should Attend
  • Clinical Affairs
  • Regulatory Affairs
  • Marketing & Sales
  • Quality and Compliance
  • Engineering/Technical Services/Operations
  • Distributors
  • Consultants

Past Events

Important

Please, check "Combination Products: FDA`s Final Rule for GMP Requirements and Introduction and Expectations for `Combo` Products" official website for possible changes, before making any traveling arrangements

Event Categories

Education: E-learning, Training
Health & Medicine: Healthcare, Medical device, Pharma

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