I have over 25 years of experience in regulatory affairs, drug development, and GMP compliance. My experience was gained in the FDA, pharmaceutical industry, and consulting environments. I have 10 years of experience at the FDA as a researcher, product reviewer, and credentialed inspector. My industry career began at Genzyme Corporation. I’ve held numerous senior and executive positions in regulatory affairs, quality, and biopharmaceutical development at Teva Pharmaceutical Industries, MDS Pharma Services, and Panacea Pharmaceuticals. While in the FDA, I served as a credentialed inspector. I conducted FDA inspections as a product expert along with the FDA District Office. I also conducted solo inspections for product and cGMP compliance. I served as a subject matter expert to FDA Office of Compliance and Office of General Counsel and participated in the issuance of untitled and titled (Warning Letters) letters. In addition, I reviewed responses to enforcement actions and determined suitability and compliance with regulations. I received internal FDA training on laws and regulations governing and interpreting cGMPs. I was responsible for the review of CMC sections of INDs and BLAs and drafted FDA Guidance documents focusing on cGMP and quality. I received numerous awards in the FDA for her work. While in industry, I designed and built GMP Quality Systems, QA and QC groups in companies. My work was both hands-on, such as drafting BPRs and SOPs, and strategic, such as conducting a gap analysis and bringing a quality system into cGMP compliance. My understanding of cGMPs has been validated by these companies successfully passing inspections by the FDA and EMA and receiving GMP compliance certificates through PIC. I have prepared companies for regulatory agency inspections, led companies during these inspections, and prepared acceptable responses to these inspections (issued Form FDA 483s). In my current position as a consultant, I advise clients on FDA compliance matters, conduct cGMP inspections and gap analyses, prepare companies for inspections, and prepare responses to regulatory agency actions. I also draft CMC sections for INDs and NDAs with a strong emphasis on cGMPs. I have served as an expert witness in a similar case. On a regular basis, I audit and consult pharmaceutical manufacturers on manufacturing and quality control deficiencies. I have been deposed 1 time and have been at trial and have testified 1 time. My testimony was on behalf of the plaintiff.
