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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