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Expertise: Amy Summers, PharmD, BCSCP is an independent consultant, specializing in business, operations, quality assurance, and regulatory compliance matters for 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 also as Managing Director of a FDA-registered 503B outsourcing facility. With extensive experience in USP standards, accreditation, cGMP, and regulatory compliance, Dr. Summers is an expert witness for all matters related to compounding, and provides evidence review, reports and testimony.

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Expertise: I, Joah Lee, am an expert in sterile and non-sterile pharmaceutical compounding with specialized knowledge of USP Chapters<795>,<797>, and<800>, as well as applicable state and federal regulatory frameworks, including those enforced by the FDA, DEA, OSHA, and state boards of pharmacy. I have extensive professional experience in overseeing cleanroom operations, aseptic technique, hazardous drug handling, and the implementation of quality assurance and environmental monitoring programs in 503A compounding pharmacy settings. I have also developed and delivered training programs for compounding personnel and have advised on compliance during internal audits and regulatory inspections.

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Expertise: Pharmacy Law, Healthcare Law, products liability, toxic tort litigation Pharmacy Law

Area of Practice: Pharmacy Law, Healthcare Law, products liability, toxic tort litigation

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