Margie Byrd is a highly respected professional providing strategic GMP and regulatory consulting services for the pharmaceutical, biotech, dietary supplement, and CBD industries. Her extensive 25+ years of experience in the global pharmaceutical industry provide a comprehensive understanding of GMPs, product development, technology transfer, manufacturing processes, quality assurance, and FDA CMC regulatory processes.
• Auditing (GMP, supplier, CMO, manufacturing, sterility assurance, laboratory)
• Quality Systems Development and Implementation (GMP, ISO)
• CMC Technical Writing
• GMP Facility/Equipment Design Review (greenfield and expansions)
• Sterility Assurance Program Evaluation
• Risk Based Commissioning/Qualification Program Development (support leveraging concepts)