QbD: An Overview of QbD Applications with some Real Practical Examples
April 28, 2011Webinar 1:00 - 2:30 ET
QbD: An Overview of QbD Applications with some Real Practical Examples
A PDA Webinar presented by:
Siegfried Schmitt, PhD
Principal Consultant
PAREXEL Consulting
Industry and regulators have undergone an iterative process in gaining a common understanding of the Quality by Design concept. This has culminated in the ICH Quality Working Group workshops in Europe (Tallinn), USA (Washington) and Japan (Yokohama).
Leaning Objectives:
At the completion of this seminar, the participants will be able to:
- Understand the regulators' expectations for Quality by Design
- Make the business case for a QbD program
- Understand what new / additional expertise will be needed to
- Find relevant references and literature
To register for the webinar, click on the event link below.
To purchase the related book with a PAREXEL 10% discount click here.
Quality by Design: Putting Theory into Practice, has been written to support progress in biopharmaceutical product quality and safety. Published at a time when approaches for adoption, implementation and interpretation of Quality by Design (QbD) are being determined, the book explores key drivers to help the biopharmaceutical industry bring new treatments to market faster and achieve cost savings, while simultaneously providing maximum assurance of product quality.
For more information on PAREXEL's Strategic GLP, GCP, GMP Compliance services and experts including a team of former FDA regulators please click here.
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