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Ensuring Success During Combination Product Testing: Part 2


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: 11:00am - 11:45am

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 considerations during product development of a drug delivery device, which can lead to a successful product development cycle and ultimately through regulatory approval. This case study will focus on transferable concepts to drive efficiencies, as well as strategies for successful risk mitigation during the development process.

Highlighted tools will revisit:

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