A Comprehensive Review of Q1D
Bracketing and Matrixing Fundamental Principles and Concepts to Reduce Stability Testing

Live, Interactive Training Webinar

Date: Wednesday November 29, 2023

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

Instructor: Kim Huynh-Ba Biography>>>

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Stability is defined as a critical quality attribute (CQA) in the drug development process, and the cost of stability program is quite significant. ICH Guideline allows to reduce stability testing for stable drug products. Q1D provides details on how these strategies can be applied and different types of reduced testing that might be used.

This live training webinar will discuss Q1D Matrixing to apply to Stability Studies, explore the fundamental principles of bracketing and matrixing. It will also show various strategies that reduced testing can be used to obtain stability data, and key factors to minimize the risk of reduce testing.

Learning Benefits:

  • Understanding different concepts of Bracketing and Matrixing.
  • When can one apply Bracketing and Matrixing concepts to reduce stability testing.
  • Discussing Bracketing concepts.
  • Discussing Matrixing concepts based on Q1D ICH Guidelines.
  • Key factors to reduce stability testing.

Webinar outline and time breakdown:

Time*

10:15 AM Log-In Period

10:30 AM Introduction

                Understanding different concepts of Bracketing and Matrixing,
When can one apply Bracketing and Matrixing concepts to reduce stability testing,
Discuss ICH Guideline Q1D,

11:30 AM 10 Minute Break

                Discussing Bracketing concepts,
Discussing Matrixing concepts based on Q1D ICH Guidelines,
Key factors to reduce stability testing,

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 Control
  • Quality Assurance
  • Validation
  • Research & Development
  • Auditor Professionals

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>>>