Faculty: Kelly Thomas | Code: FDB3099
In the dynamic pharmaceutical landscape, each drug product possesses its own distinctive characteristics, stemming from diverse components, chemical and physical properties of APIs, manufacturing methods, excipients, formulations, and storage conditions. As a result, the establishment of comprehensive requirements for expiration and stability is pivotal in ensuring compliance with current good manufacturing practice (cGMP) standards for finished pharmaceuticals.
Join this exclusive webinar focused on regulatory requirements and cutting-edge practices to establish top-notch product stability programs. Gain valuable insights into FDA-compliant strategies for expiration dating and stability testing, perfectly tailored to various product types.
WHY YOU SHOULD ATTEND:
In just 60 minutes, you'll discover the strategic significance of implementing FDA-recommended good practices, ensuring your firm remains compliant and stays well-prepared against potential FDA enforcement actions. Stay ahead of the curve with heightened awareness as we reveal the latest perspectives of FDA on product stability testing programs.
This product stability testing webinar leaves no stone unturned, delving deep into the FDA's stringent drug stability guidelines for diverse drug products. Learn how to expertly design a product stability testing plan that can be seamlessly applied to both new and modified products within the pharmaceutical, biotechnology, and medical device industries.
AREAS COVERED IN THE SESSION:
Introduction of a Stability Testing Plan and Program
General Stability Considerations Applicable to a New Product (i.e. Potency)
Stability Schedule (Suggested Schedules for Conducting Stability Studies)
Temperatures of Studies Based on the Product Type
Analytical Testing Considerations
Stability Testing Protocol Design
Stability Testing Data Management and Trending
Manual versus Automated Data Management
Advantages and Disadvantages
You will also get answers to the following tough questions:
WHO SHOULD ATTEND:
Ms. Thomas has over two decades of cGMP hands-on industry experience in both pharmaceutical and medical device manufacturing operations. Her experience covers all Quality Systems; as well as, all areas of validation; including, process/product validation, facilities validation, CSV and 21 CFR Part 11, test method validation, equipment/automated processes and cleaning validation.
Utilizing strategic thinking, risk based approaches, and Lean principles, she has demonstrated success in steering and managing complex projects within the pharmaceutical and medical device industries.