Anita Michael

Executive Principal Consultant, Pharma Compliance

Anita Michael joins RCA as an Executive Pharma Compliance Expert & Principal Consultant. She has 23+ years of global regulatory and quality experience, including 16 years’ operating globally as a Pharmaceutical Expert, FDA Investigator and FDA Pre-Approval Manager. Anita has excellent interpersonal, empathetic communication and client management skills that enable her to skillfully coach and collaborate with clients at the highest levels of an organization and prepare them for successful FDA inspections (ANDA/NDA/BLA/PMA Pre-Approvals) and global regulatory and quality assurance audits across Biotech, Biologics, Sterile Operations, Drug Substances, and 503A/B. She has been Keynote Speaker for the Pharma Industry and internally to the FDA throughout her career.

Anita experience includes positions as Vice President of Quality Assurance, Regulatory Affairs and Validation, as well at the Executive Director Level in Quality Assurance including numerous years as a Principal Consultant for QA and Regulatory. She is specialized in 6 System Inspection Readiness, CGMP training, Remediation, Compliance, Consent Decree, Warning Letter, FDA 483 responses to the FDA and Global Regulatory Agencies.

She has reviewed and helped design innovative modern corporate quality systems, advanced modern manufacturing facilities for global pharmaceutical companies worldwide. She specializes in preparation, remediation and designing of training for individuals at all levels of an organization. She has successfully led multiple QA teams and provided hands on trainings, mentoring and enhanced company quality management systems throughout the lifecycle of the product. She is expertly versed in the Food Drug and Cosmetic (FD&C) ACT and current Good Manufacturing Practices (CGMPs), 21 CFR 210, 21 CFR 211, CFR 600 and Part 11 requirements and the practical application to assure a company operates across all site locations in a state of control and compliance and has assessed over 300+ pharmaceutical companies worldwide throughout her career. She is versed and experienced in Device Drug Combination products covering the device QSR (cross labeled, co-packaged and single entity) and 21 CFR 4.1, 21 CFR 820 and 21 CFR 210/211.

Anita has received numerous outstanding awards and recognition from 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.