Always Inspection Ready: Mastering FDA Inspection Preparation and Response

Steve has over twenty (20) years of quality and regulatory compliance-related experience in the pharmaceutical, biopharmaceutical, medical device, blood, plasma, and tissue industries. He is an expert in Current Good Manufacturing Practices (CGMP) compliance-related matters and has significant experience with other GxP quality compliance and regulatory issues. Steve served in executive leadership roles with global accountability in both the private sector, as well as at the US FDA. In the private sector, Steve was an executive at two large multi-national corporations and also worked as a consultant for multiple large, mid-sized, and small clients.

Anita Michael has over 25 years of global pharmaceutical regulatory and quality experience. She spent 16+ years at the U.S. FDA as a Global Pharmaceutical Expert, leading nearly 300 inspections worldwide across biotech, sterile manufacturing, drug substance, and OTC product lines. Anita has held executive and director-level roles in Quality Assurance, Regulatory Affairs, and Validation. She is a recognized industry leader in GMP inspection readiness, FDA response strategy, and modern quality system design, and has been a keynote speaker at numerous global conferences. Her contributions have earned her multiple awards from both the FDA and the pharmaceutical industry.