This educational web seminar will provide guidance for implementing QbD with biopharmaceuticals, including consensus recommendations from industry working groups and progress from collaboration between industry and regulators; advice for building a the business case for QbD, and a case study in QbD implementation.

Current Consensus Thinking on Quality by Design
John K. Towns, PhD, Senior Director, Global CMC Regulatory Affairs Eli Lilly and Company

Not on the inside track? Find out here what participating pharma and biotech companies have been discussing in various collaborative working groups on QbD – such as the PhRMA QbD working group and the A-Mab case study – and what’s happening in the FDA Quality by Design pilot for biotechnology. Learn on what points consensus has been reached, and where is there still disagreement – within the industry or between industry and regulators – or just plain uncharted territory.

Building the Business Case for QbD
Beth Junker, PhD, Senior Scientific Director, Biologics Pre-Clinical Development Merck

Wondering how to strategically evaluate and implement QbD? This talk will present key principles for evaluating the ROI of QbD, as well as setting up an internal program for QbD implementation, including how to handle change management.

Case Study in QbD Implementation: Risk Assessments for Raw Materials Management
Duncan Low, PhD, Scientific Executive Director, Process Development Amgen Inc.

In applying QbD, risk assessments are a critical starting point. This talk will present a case study of implementing risk assessment methods for raw materials management, which can then serve as a foundation for further QbD development as well as reducing quality risks throughout the product lifecycle.

product lifecycleFor more information please contact Jamie Carpenter at jcarpenter@advanstar.com