Developing and Validating Stability Indicating Methods to Support Stability Program Using Forced Degradation Studies
Live, Interactive Training Webinar
Date: Available Live On-Demand
Instructr: Kim Huynh-Ba Biography>>>
Date: Available Live On-Demand
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 method and the forced degradation studies to address method specificity. We will also discuss compendial methods used in the stability program and method verification.
-Impact of analytical testing in the drug development process. -Establish key factors for stability indicating methods. -Understand specificity requirement based on Q2 A&B. -Design forced degradation studies to challenge analytical procedures. -Key considerations working with compendial methods. -Understanding the relationship among validation, verification and transfer.
Webinar outline and time breakdown:Time*
|9:15 AM||Log In Period|
|Background of analytical testing to support the drug development process,|
|Discuss regulatory expectations through warning letters,|
|Lifecycle approach for method validation,|
|Establish key factors for stability indicating methods,|
|10:40 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,|
|11:30 AM||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
- Research & Development
- Auditor Professionals
- Regulatory Affairs Professionals
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>>>
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