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 speaker, Aaron Liss, 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
Aaron Liss, Business Development, AMRI
Aaron Liss has over 12 years of contract research testing experience within the medical device and pharmaceutical industries. He has a passion for developing rapport and building partnerships with clients to meet project timelines, regulatory endpoints and strategic business goals. Prior to AMRI, Aaron worked as a Key Account/Regional Account Manager for WuXi AppTec and a Global Account Manager for Heraeus Medical Components. In addition to his business development roles, Aaron has held a variety of technical positions ranging from Research Scientist to Study Director. Aaron has a Bachelor of Sciences in Biology from St. John’s University and completed his MBA at Hamline University in Minnesota.Message Presenter
Charles Felter, Microbiology Manager, AMRI
Charles Felter serves as the Microbiology Manager at Whitehouse Laboratories, including Biological and Microbiological analysis. Charles has over 10 years of experience in the pharmaceutical industry, in both quality assurance and laboratory operations, including analytical/chemical, bioanalytical/biopharmaceutical, microbiological, and biological analyses and validation. He is a certified Lead Auditor by RABQSA with experience leading internal/external audit programs and hosting client and regulatory audits. He is a graduate of Dartmouth College, with an AB in Biology.Message Presenter
Who Should Attend?
This webinar will appeal to senior-level professionals from pharmaceutical, biotechnology and medical device companies and research/academic institutions.
- Chemistry/Professional Chemistry/Medicinal Chemistry
- Analytical Chemistry
- Analytical R&D
- Clinical Operations
- Chief Scientific Officers
- Research Scientists
- Packaging Engineering
- Container Engineering
- Biotechnology Packaging
- Pharmaceutical Packaging
- PDA members
What You Will Learn
Participants will gain insights into:
- Overview of container closure systems and their components
- Types and applications of logistical tests for various closure systems
- USP regulatory trends and other packaging requirements
AMRI, a global contract research and manufacturing organization, partners with the pharmaceutical and biotechnology industries to improve patient outcomes and quality of life. With locations in North America, Europe and Asia, AMRI’s team combines scientific expertise and market-leading technology to provide a complete suite of solutions in Discovery, Development, Analytical and Solid State Services, API Manufacturing and Drug Production.