معرفی
Brent Lewis is an Affiliate Assistant Professor in the Department of Pharmacy at the University of Washington School of Pharmacy. He holds a bachelor’s degree in biology from Seattle University and teaches the course PHRMRA 536, focusing on skills for regulatory affairs professionals. His career spans biotechnology and global medical device sectors, where he established quality control labs, managed FDA submissions, and harmonized quality, regulatory, and business operations.
Research Interests: Lewis specializes in regulatory compliance, quality assurance, and the intersection of IT with pharmaceutical and medical device development. His work emphasizes streamlining regulatory processes and enhancing quality systems for complex product submissions.
Professional Background:
- Former Vice President of Quality and Regulatory Affairs at global medical device companies
- Current IT leader for quality, regulatory, R&D, and commercial solutions
- Experience in FDA inspections, warning letter resolution, and mergers/acquisitions
