Amy Summers, PharmD, BCBSP, Pharmacist Consultant at Two Trees Consulting, is a regulatory compliance expert in the pharmaceutical compounding industry. She earned her PharmD degree from the University of California San Francisco and was among the first pharmacists in the nation to earn a Board-Certified Sterile Compounding Pharmacist (BCSCP) credential. Dr. Summers has spent her entire career as a pharmacist in various settings centered around non-sterile and sterile compounding. She has formerly served as Director of Operations and Pharmacist in Charge at organizations engaged in compounding and as Managing Director of an FDA-registered 503B outsourcing facility.
With extensive experience in USP standards, accreditation, cGMP, and regulatory compliance, Dr. Summers has also served as an expert witness for matters related to compounding.
Amy joined Two Trees Consulting as a Pharmacist Consultant in 2021 helping clients design sterile compounding facilities and start up, prepare for board inspections, develop SOPs to meet USP standards, and PCAB accreditation.
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