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Ensuring Success During Combination Product Testing: Part 1


John Iannone (Director, Extractables/Leachables & Impurities, Albany Molecular Research, Inc. (AMRI))

Frank Bieganousky (Associate Director, Container Qualification & CCIT, Whitehouse Laboratories, LLC)

Brandon Zurawlow (Associate Director, Container Qualification & CCIT, Whitehouse Laboratories, LLC)

Location: 210C

Date: Thursday, February 8

Time: 10:15am - 11:00am

Pass Type: Conference (Paid) - Get your pass now!

Conference Track: MD&M: Technical Solutions

Vault Recording: TBD

Bringing medical devices to market requires careful selection of materials, design controls, demonstrated efficacy, product safety, and strategic planning. This session will host three experts in their respective fields, each highlighting key regulatory testing necessary to bring a combination product to market. This case study will focus on transferable concepts for mitigating risk, resulting in successful regulatory acceptance.

Topics to be covered include:

  • Material selection (Extractables/Leachables & risk assessments)
  • Safety evaluations (overall biocompatibility)
  • Deterministic Container Closure Integrity Testing (CCIT)
  • Medical device functional testing
  • Packaging