Perspectives on Assessment, Assurance and Drug Quality

In today's featured presentation from Biopharmceutical Development and Production Week 2014, Jeffrey C. Baker, Ph.D., Deputy Director, Office of Biotechnology Products (OBP), Center for Drug Evaluation and Research, U.S. FDA talks about the FDA’s work environment is of assurance, assessment, and assertion, the space of assertion that a company has, process validation (making an assertion and being an advocate, in a data driven way),and the many ways to look at quality by using different tools to evaluate it. Baker stated that he believes that design is about providing an experience.

Want to learn more? Watch the first part of the presentation here:


Biopharmaceutical Development and Production Week is will take place March 30-April 2. The agenda will feature more unique insights into the regulations of biopharmaceutical production so be sure to sign up to receive program updates for the 2015 agenda.

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