The objective of this webinar is to address United States Pharmacopeia (USP) and FDA regulatory trends to demonstrate how to integrate various analytical tests into a robust program that addresses product integrity/compatibility throughout the product lifecycle.
TORONTO (PRWEB) August 13, 2019
A product’s container closure system is a highly important component of a product’s effectiveness for the pharmaceutical, biologics, and biotechnology industries. A container closure system will protect the product from environmental conditions and will ensure a product’s strength, purity, safety and efficacy through expiry.
There are several tests that are performed on container closure components, the container closure system and the secondary components related to logistics that will ensure the correct container closure components have been selected and are adequate to ensure the quality of the end product.
The objective of this webinar is to address United States Pharmacopeia (USP) and FDA regulatory trends to demonstrate how to integrate various analytical tests into a robust program that addresses product integrity/compatibility throughout the product lifecycle. This includes selection and development of the packaging systems and associated challenges of the packaging systems (stability storage, accelerated aging, freeze-thaw, altitude, drop, and vibration distribution simulation, and routine release of commercial product).
Join featured speakers from AMRI Aaron Liss, Business Development and Charles Felter, Microbiology Manger in a live webinar on Wednesday, September 4, 2019 at 11am EDT (4pm BST/UK) to learn about the types of tests available and the types of tests regulatory agencies expect to be performed to ensure a product’s container closure system is adequate.
Topics will include:
- Component / Container Functionality and Dimensional testing per USP/EP/JP/ISO/Custom Methods
- Container Closure Integrity testing per USP 1207
- Extractable and Leachable testing
- Distribution testing per ISTA, ASTM and ISO
- Compendial / Analytical Testing / Stability per USP/EP/JP/ISO/Custom Method
For more information or to register for this free event, visit Key Considerations for End-to-End Primary Packaging Solutions for Pharmaceuticals & Devices.
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