Brandy Lewis


Principal Quality Consultant and Director, Thirteen Consulting Group Inc

Brandy Lewis has 23 years of pharmaceutical quality assurance and quality systems experience in both industry and consulting roles. Ms. Lewis has worked in clinical supply and commercial manufacturing environments, and has experience with integrated manufacturing and contract manufacturing business models. She has extensive expertise in the areas of change control, GMP training, and regulatory inspection preparation and management.

Working with both small and large companies, Ms. Lewis has successfully developed and implemented key quality systems for the appropriate phase of the company. She is an experienced GMP trainer, and has developed and delivered customized interactive training presentations for many companies. She has also provided FDA/FDB/ISO inspection/audit support for several companies and clients, including readiness training, on-site assistance during inspections, and authoring written responses to inspectional observations. Prior to becoming a consultant in 2014, Ms. Lewis was the head of Quality at four (4) companies in the San Diego area.

Upcoming Events

Managing an Effective AML Compliance Program: 2-day In-Person Seminar
- San Francisco, CA | Thursday, August 6, 2015 | Friday, August 7, 2015
- Philadelphia, PA | Thursday, November 12, 2015 | Friday, November 13, 2015

View Details | Register