Manufacturing and Bioprocessing – Chemical

2019 PharmSci 360

Keynote: Process Validation Opportunities – A Regulatory Perspective

Keynote Speaker(s)

• 

  Christina Capacci-Daniel, PhD

  U.S. Food and Drug Administration
  Silver Spring, Maryland

Moderator(s)

• 

  Ashlee Brunaugh, Pharm.D.

  University of Texas at Austin
  Austin, Texas

Process validation is a strategy for building, demonstrating, and maintaining a robust manufacturing process, which is critical for ensuring product quality. This presentations will identify Process Validation opportunities for products at all lifecycle stages, as well as for emerging technology like continuous manufacturing.

Learning Objectives:

• Identify advantages of Process Validation in product development and commercial operation.
• Apply Process Validation principles to emerging technologies like continuous manufacturing.
• Convey the importance of Process Validation as a continual process for maintaining and enhancing product quality.