Pre-Conference Workshop | May 7, 2019

Chemical Safety Qualification and Biocompatibility of Packaging Systems and Medical Devices

“An Analytical Chemistry Perspective”


 I. Introduction -12:00 PM
  • What is chemical safety qualification?
  • What is biocompatibility?
  • US regulatory perspectives
II. Chemical Safety Qualification -  12:40 PM
  • The PQRI recommendations and perspective
  • Extractables assessments (chemical characterization)
  • Leachables assessments
  • Preparing an individual chemical safety assessment

(Networking Break) - 1:40 PM

III. Biocompatibility - 2:00 PM
  • FDA CDER perspective (USP)
  • FDA CDRH perspective (ISO 10993)
  • Packaging systems (USP)
  • Medical devices (ISO 10993)
  • Combination products
IV. Summary - 3:00 PM
  • What does all this mean for pharmaceutical development?
  • Where is USP headed?
  • Where is ISO 10993 headed?
  • Where is FDA headed?

Workshop Concludes - 4:40 PM  


Coordinated by   Paul Cummings, General Manager of Smithers Rapra Analytical Services & Dr. Daniel Norwood, Executive Partner of SCIO Analytical & Senior Consultant at Smithers Rapra.


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Register for Extractables & Leachables US 2019 + Workshop 

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