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
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.