Monitoring Impurities in Pharmaceutical Products to Meet FDA and ICH Q3 A/B Requirements
Live, Interactive Training Webinar
Available Live On-Demand
Instructor: Kim Huynh-Ba Biography>>>
Available Live On-Demand
Monitoring impurities is considered a critical activity of analytical development in order to ensure the quality of the pharmaceutical products. Current ICH Guidelines indicate that the measurement of impurities should always be conducted for active pharmaceutical ingredient (API) and its drug products. This live training session will discuss the requirements of ICH Q3A/B on organic impurities and different thresholds to monitor them in the Active Pharmaceutical Ingredients or Drug Products. Concept of Quality by Design (QbD) will also be discussed and applied to the development of analytical procedures including the key factors to be considered through the product lifecycle.
Upon completion of this live training session, attendees will understand regulatory requirements in the monitoring of pharmaceutical impurities. Participants will gain practical knowledge about key considerations when reporting impurities for regulatory submission. This session will also discuss observations and infractions that were obtained due to recording and reporting impurities in pharmaceutical labs.
-Understanding regulatory expectations for organic impurities. -Discussing warning letters and citations for impurity monitoring. -Understanding regulatory requirement guidelines surrounding impurities in API and Drug Products. -Reviewing ICH Q3A for controlling impurities in API and Q3B for impurities in Drug Products. -Differences between Process impurities versus degradation products. -What to be monitored for API and Drug products. -Understanding different thresholds to report for regulatory submission. -Monitoring impurities through the product lifecycle.
Webinar outline and time breakdown:Time*
|10:15 AM||Log In Period|
|10:40 AM||Understand regulatory expectations,|
|Discuss warning letters and citations,|
|Understand regulatory requirement guidelines surrounding impurities in API and Drug Products,|
|11:40 AM||Review ICH Q3A for controlling impurities in API and Q3B for impurities in Drug Products,|
|Understand different thresholds to report for regulatory submission,|
|Review USP General Chapters <476> and <1086>,|
|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
- Pharmaceutical Scientists
- Compliance Scientists
- 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>>>
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