Change Control Management for a Stability Program – Potential Changes and Minimizing the Impact of Registration

Live Web Training Courseliveondemandfinal
Instructor: Kim Huynh-Ba
Last Conducted on:
Tuesday, August 10, 2010

Introduction:(Click here for Agenda based on  North American & International Time Zones)

The stability program is vital to the manufacturing of pharmaceutical products, with inevitableKim Huynh-Ba, M.S changes throughout the product life cycle.  Examples of these changes include formulation improvement, new findings such as impurities, varying market requirements, additional packages and different formulation.  These changes will influence the stability profile of the finished product, significantly impacting the drug development, regulatory submissions and commercialization.

This live and interactive BenAstrum web training course will focus on potential changes in a stability program, and how to develop a change control system that minimizes the impact of registration for these products.

Discussion Points:

  • Why Stability is defined as a critical quality attribute
  • What type of CMC changes in the life cycle of a drug product
  • How changes affect the stability profile of the product throughout the expiry
  • Distinguish between minor and major changes of a registration stability program
  • Determine potential risks to manage these stability changes

Who Can Benefit:

This session will benefit analytical chemists, regulators and researchers who are involved in making or managing changes to the process.  It is highly recommended that you have at least two years of experience in the pharmaceutical industry to obtain the full benefit of this course.