Anita Michael

Executive Principal Consultant, Pharma Compliance

Anita Michael joins RCA as an Executive Pharma Compliance Expert & Principal Consultant. She has 25+ years of global pharma regulatory and quality experience. Anita has 16+ year’s direct experience with the US Food and Drug Administration operating as their Global Pharmaceutical Expert for advanced Pharmaceuticals, leading FDA Inspections and Acting FDA Pre-Approval Manager for drug approvals, BLA, PMA NDA, ANDA, CMC. Anita has led ~ 300 FDA advanced global pharma Inspections across biotech, sterile operations, drug substance, 503 and OTC product lines.

Anita’s global pharmaceutical industry experience includes Executive positions as Vice President of Quality Assurance, Regulatory Affairs and Validation and Director Level positions in QA and numerous years as a Principal Consultant for Quality Assurance and Regulatory. She designs innovative modern corporate quality systems, advanced modern manufacturing facilities worldwide securing product approvals. She specializes in GMP inspection readiness, FDA 483 responses, warning letter remediations and GMP training for individuals at all levels of an organization.

Ms. Michael has been the Keynote Speaker on numerous occasions for Global Pharmaceutical Conferences. Anita has received numerous outstanding awards and recognition from the Pharmaceutical Industry and at the highest levels of the FDA including multiple awards such as the US FDA Commissioner’s Special Citations, US FDA Commendable Service and Dedication Awards and multiple US FDA Outstanding Service Awards.

Anita has a B.S. in Biology and Chemistry minor in Sociology, Magna Cum Laude from Temple University receiving the highest honors and has studied as a Medical Student at Drexel University School of Medicine. She has completed graduate courses at North Carolina State University in advanced BIOTECH processing.