Developing and Validating Stability Indicating Methods to Support Stability Program Using Forced Degradation Studies
Live, Interactive Training Webinar
Date: Wednesday July 10, 2019 - Time: 10:30 AM - 12:30 PM (Eastern New York Time)
Instructor: Kim Huynh-Ba Biography>>>
Analytical procedures are essential tools to assure that the drug product meets applicable standards of identity, strength, quality and purity during its shelf life. cGMPs require stability indicating methods to monitor the drug product’s stability profiles. Therefore, forced degradation studies are important to establish the stability indicating power of methods used for stability program.
This live session will discuss validation requirements according to ICH Q2 R1 and FDA guidance on analytical method validation, expectations for stability indicating methods and the forced degradation studies to address method specificity. We will also discuss compendial methods used in the stability program and method verification.
-The impact of analytical testing in the drug development process.
-Establishing key factors for stability indicating methods.
-Understanding specificity requirement based on Q2 A&B.
-Designing forced degradation studies for API and drug products.
-Key considerations working with compendial methods.
-Understanding the relationship among validation, verification and transfer.
Webinar outline and time breakdown:
10:15 AM Log In Period
10:30 AM Introduction
10:40 AM Background of analytical testing to support drug development process,
Discuss regulatory expectations through warning letters,
Lifecycle approach for method validation
Establish key factors for stability indicating methods,
11:30 AM Break
11:40 AM Understand specificity requirements based on Q2A&B,
Forced degradation studies to challenge validation,
Working with compendial methods and method verification,
Understanding lifecycle method validation,
12:30 PM Live Questions & Discussion
*Please note all times are Eastern Time (New York Time)
This live training webinar includes the following for each registered attendee:
A copy of the presentation slides
Reference to the ICH Guidances
A certificate of participation for attendee training records
Who should attend:
The following individuals or disciplines will benefit from attending this Webinar:
Quality Assurance personnel
Quality Control personnel
Analysts and Laboratory Managers
Regulatory Affairs Professionals
Manufacturers of raw material and ingredients
Instructor: Kim Huynh-Ba
Kim has almost 25 years of experience in analytical development, project management, strategic drug development and stability sciences. Prior to Pharmalytik, she held technical positions in drug development at Astra Zeneca (formerly ICI Americas), DuPont Merck, DuPont Pharmaceuticals, Bristol Myers Squibb and Wyeth Vaccines. Her experiences range from analytical development to supporting CMC activities of multiple regulatory submissions, addressing regulatory responses to observations or investigations, or developing stability submission strategies.
She is an Adjunct Professor at Temple University-School of Pharmacy, Illinois Institute of Technology and Widener University. Kim currently is a member of United States Pharmacopeia (USP) General Chapter Expert Committee (2010-2015) and USP’s Reference Standard Project Team (2009-2010). She is also a member of the CHPA’s Impurities Breakout Group. She is chair of AAPS APQ Distance Learning and organized several APQ Open Forums. She serves on the Executive Committee of Governing Board of Eastern Analytical Symposium (EAS). She is the editor of the “Handbook of Stability Testing in Pharmaceutical Development: Regulations, Methodologies and Best Practices” published in 11/2008, and also “Pharmaceutical Stability Testing to Support Global Markets” published in 01/2010… Full Bio>>>
Course Number: 280
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