Carolyn’s supply chain validation experience spans the development and commercial components with the pharmaceutical and biologics space. With responsibility of shipping process development and validation for five new biologics, she was the obvious candidate to respond to and facilitate direct contact with the regulators during pre-approval inspections. As an active contributor within the industry, she is a thought leader in topics related to regulatory submissions, project plans, protocols, reports, SOPs, risk assessments and change control. Carolyn has been an active participant and presenter at PDA, ISTA, and IQPC where she is currently serving on the Advisory Board. Most recently, Carolyn co-authored a USP Stimuli Article Best Practice Guideline for Reusable Passive Thermal Packaging Systems.
Carolyn is President of Parenteral Supply Chain, LLC. She is a Midwest girl happily living in the Syracuse, NY area raising her three kids. She is a Green Bay Packer fan, loves to travel, and is an avid runner enjoying the challenges of marathons.