The Keys to a Compliant Stability Program and the Latest FDA & ICH Requirements
Live, Interactive Training Webinar
Available Live On-Demand
Instructor: Kim Huynh-Ba Biography>>>
Available Live On-Demand
Stability is recognized as a Critical Quality Attribute (CQA) worldwide. Stability data are used to determine the expiration dating and the intended storage condition of pharmaceutical products. Several international guidelines have been issued for stability program and companies must adhere to these requirements to gain market access to these countries. These requirements can be quite different such that conducting stability studies become very expensive and cumbersome. Therefore, maintain a stability in compliant state can be challenging and costly. This is essential to many companies with limited resources to focus on key components of stability studies and design the program accordingly. It is also important for those manufacturers that outsource stability testing to understand what are expected when working with CROs.
This live and interactive training webinar will focus on key issues to keep the stability program in compliance. Topics of discussion will include stability protocol, stability operation, investigation of OOS/OOT stability data, stability submission reports
-Stability Requirements in the drug development process.
-Define Stability as a Critical Quality Attribute.
-Developing and validating Stability Indicating Methods.
-Establish Global Stability Protocol.
-Evaluate Stability Operations.
-Key factors of OOS/OOT investigations.
-Establish Stability Submission and Reports.
Webinar outline and time breakdown:Time*
|12:45 PM||Log In Period|
|01:10 PM||Stability Requirements from FDA and ICH,|
|Establish key factors for stability indicating methods,|
|Discuss global stability protocol,|
|02:10 PM||Evaluate Stability Operations,|
|Key factors of OOS/OOT Investigation,|
|Stability Submission and Reports,|
|03:00 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
- Research & Development
- 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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