Conducting Out-of-Trend Investigations and Establishing CQA Using Risk Management

Live, Interactive Training Webinar

Date: Wednesday September 27, 2023

Time: 10:30 am - 12:30 pm ET (New York Time)

Instructor: Kim Huynh-Ba Biography>>>

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This live webinar examination will include OOT for stable and changed properties of drug products to establish trend to monitor product profile. Risk assessments will be introduced to determine critical quality attributes and how to work with cross-functional team to continuously improve the product.

Learning Benefits:

  • Recognize different types of OOT results.
  • Establish trend for release and stability data.
  • Understand risk assessments to determine Critical Quality Attribute (CQA).
  • Determine course of actions to process.
  • Understand cross-functional investigations.
  • Monitoring product trends to avoid OOS.

Webinar outline and time breakdown:

Time*

10:15 AM Log-In Period

10:30 AM Introduction

                Recognize different types of OOT results,
Establish trend for release and stability data,
Understand risk assessments to determine Critical Quality Attribute (CQA),

11:30 AM 10 Minute Break

                Determine course of actions to process,
Understand cross-functional investigations,
Monitoring product trends to avoid OOS,

12:30 PMLive 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
  • A certificate of training 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 and Development
  • Regulatory Affairs Professionals
  • Auditors
  • Validation

How to Attend:
All Pharma Webinars live training programs audio and visuals are delivered via Cisco WebEx with a basic system requirement of a computer with internet access. You do not require a Webex account to join Pharma Webinars’ live training courses, participants receive an email invitation that provides the access you need to join the meeting.

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 AstraZeneca (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>>>