Anita R. Michael

Anita R. Michael

Anita R. Michael

Principal Consultant

Anita has more than 20 years direct experience in GMP requirements, quality systems, commercial manufacturing, pharmaceutical research, development, global pharmaceutical regulatory expertise and Drug Program Management. She has reviewed and helped clients design corporate quality systems, validation protocols and manufacturing facilities and also specializes in preparation, remediation and designing of training for individuals at all levels of an organization. 

Work Experience

Anita has 16 years direct experience with the FDA operating as their Global Pharmaceutical Expert for FDA Inspections, Drug Approvals, NDA, ANDA, CMC application review, for cause inspections and investigations. She has conducted hundreds of PreApproval Inspections, Post Approval Inspections, Pre-Market Approvals, Data Integrity, Validation and cGMP Inspections both domestically and internationally specializing in biopharmaceuticals, sterile dosage forms and aseptic processing, solid dosage forms, solutions, drug and device combinations and APIs. Anita has been the lead on numerous FDA For Cause Inspections, Warning Letters, Injunctions and Criminal Cases and has served as the Expert Witness for the US FDA. She is also well versed in Device Drug Combination products covering the device QSR (cross labeled, copackaged and single entity) and 21 CFR 4.1, 21 CFR 820 and 21 CFR 210/211. 

Education

Anita has a B.S. in Biology, Minor in Sociology and Chemistry, Magna Cum Laude from Temple University and has studied as a Medical Student at MCP Hahnemann School of Medicine. She has been the key note speaker at numerous global pharmaceutical conferences and served as the expert for industry technical papers and FDA Drug Guidance Documents and Compliance Program Manuals. 

We are always available for a conversation.

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