Shirley Berryman
TCG Consultant
Consultant at Toscano Consulting Group, Inc. (TCG), Ms. Berryman has more than 20 years’ experience with Food and Drug Administration (FDA). She worked as an FDA Investigator conducting inspections/ investigations in all drug dosage forms both domestic and internation. She also conducted criminal investigations five (5) of those years.
Ms. Berryman received her Level III Drug Investigator and achieved the Pharmaceutical Drug Inspectorate in 2011 (Pharmaceutical Inspectorate (A group of Field Investigators who have specialized experience and specific training in evaluating pharmaceutical manufacturing.) She was the Kansas City District Pre-Approval Manager (PAM) for 15 years, had a detail to FDA’ s Compliance Branch for 5 years, and a 60day-detail as International NDA Pre-Approval Manager.
After leaving the FDA, Ms. Berryman has been conducting Mock-FDA audits, Pre-approval Inspections and follow-up to FDA Warning Letters both domestic and international. In addition, she has audited over 11 Outsourcing Pharmacies, 503(b). She also performed a four (4) year remediation assignment for three sterile facilities and was Team Lead for two (2) of the sites for 1.5 of those years. Ms. Berryman has also reviewed several FDA 483 responses related to Warning Letters for completeness. She has performed over 35 solo and team mock-FDA audits in her consulting career.
Ms. Berryman received a Bachelor’s degree from Columbia College and Associates Degree from Long View Community College in Criminal Justice Administration with over 30 hours in the Sciences.