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Effective Combination Product Risk Management Programs

Susan Neadle (Senior Director Global Value Chain Quality Design, Johnson & Johnson)

Jennifer Riter (Senior Director – Analytical Lab Services, West Pharmaceutical)

Location: 210C

Date: Wednesday, February 12

Time: 9:45am - 11:45am

Track: MD&M Conference: Materials, Testing & Risk Management Solutions

Vault Recording: TBD

Drug-device combination with complex controls or unexpected device operation can lead to increased patient risk. Combination Products Risk Management integrates human factors and other control strategies to enable effective design that promotes overall system performance. As pharma and medical device companies develop drug delivery products, new and complex interactions within the primary packaging components and delivery systems arise, and it’s critical to understand the compatibility and performance of the entire system inclusive of the drug and device for a successful control strategy.

Topics covered include:

  • Understanding the chemical compatibility and the physical and functional aspects of components and the device as a single system
  • Key considerations around analytical testing during development,
  • Better practices for risk management of extractables and leachables, container closure integrity, performance, and stability analysis

Presentation Files

ANA2020_EffectiveCombinationProductRiskManagement_Riter.pdf
ANA2020_Combination_Products_Risk_Management_Neadle.pdf