Your pharmaceutical product’s container closure system is a highly vital 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.
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, Charles Felter, to learn about the types of tests available and the types of tests regulatory agencies expect to be performed to ensure your product’s container closure system is adequate.
Key Learning Objectives:
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
Who Should Attend:
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
Parenteral Drug Association members
Regulatory Affairs Professionals
Charles (Chad) Felter, Site Lead, Lebanon, NJ
Charles (Chad) Felter serves as the site lead for Pace® Life Sciences laboratory in Lebanon, NJ focusing on CCIT services and Biological and Microbiological analysis. Charles has over 15 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.
Ryan Lichty, Scientist III / Project Manager – Container Closure Integrity
Ryan Lichty serves as the Subject Matter Expert for the Container Closure Integrity Testing department at Pace Life Sciences laboratory in Lebanon, NJ. As a Scientist and Project Manager with seven years' experience leading the CCIT team, Ryan specializes in CCIT program design, test parameter optimization, method validation, and root cause analysis. His favorite part of his role at Pace is having the opportunity to prepare customized CCI testing solutions for unique package systems.
Jack Thornquest, Senior Account Executive
Jack Thornquest is an Sr Account Executive and has been with Pace in Lebanon, NJ and its predecessor, Curia Global, since 2019. Previous to that, Jack was an analytical scientist focusing on mass spectrometry for more than 25 years at companies based in the Research Triangle Park area of North Carolina ranging from small biotech to large pharma. Jack is a co-author on five peer-reviewed publications as well as a number of presented posters and invited talks.