Already a DIA Member? Sign in. Not a member? Join.

Sign in

Forgot User ID? or Forgot Password?

Not a Member?

Create Account and Join

Hyatt Regency Bethesda

Apr 13, 2015 7:00 AM - Apr 15, 2015 12:00 PM

One Bethesda Metro Center, 7400 Wisconsin Avenue, Bethesda, MD 20814-5326

CMC Workshop 2015

Session 8A: Modelling (Chemicals)

Session Chair(s)

Frank  Montgomery, PhD

Frank Montgomery, PhD

Global Head Regulatory CMC, GRAPSQA

AstraZeneca, United Kingdom

The Points to Consider ICH Endorsed Guide for ICH Q8/Q9/Q10 Implementation describes the use of models and their categorization from high to low impact depending on level of risk to patient when used as part of the control strategy. There are a variety of ways that this information can be incorporated into the control strategy to assure product quality and process consistency as part of a marketing application. This session will look at a variety of ways that models have been used to support marketing applications, the data and statistical analysis that was needed gain approval, and some considerations of how this could evolve in the future. For example a Design Space may be associated with RTRT, or may be part of a control strategy that includes extensive end-product testing; consequently the degree of assurance and the level of statistical confidence required can vary.

Speaker(s)

John  Lepore, PhD

Model Implementation: It Really Is All About the Control Strategy

John Lepore, PhD

Merck & Co. Inc., United States

QbD and CMC Practices Lead, Global Pharmaceutical Commercialization

Matt  Popkin, PhD

Science and Strategy: The Role of Models in Achieving Manufacturing Flexibility

Matt Popkin, PhD

GSK, United Kingdom

Senior Director, CMC Excellence, Global Regulatory Affairs

Nathan  Ide

Statistical Models and Tools for the Assessment of Process Parameter Criticality

Nathan Ide

Pfizer, United States

Senior Principal Scientist

Have an account?

Be informed and stay engaged.

Don't miss an opportunity - join our mailing list to stay up to date on DIA insights and events.