Amy Summers
503A & 503B Compounding ConsultantRestore Health Consulting LLCAmy Summers, PharmD, BCSCP is an independent consultant, specializing in business, operations, quality assurance, and regulatory compliance matters for the pharmaceutical compounding industry with extensive cGMP experience. 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.
E84 – Evolving Clinical Lab Planning: Compliance Triggers for BSL, cGMP, and PCR
Healthcare Clinical laboratory environments are evolving beyond traditional diagnostic spaces, driven by advances in translational research, molecular…Healthcare Clinical laboratory environments are evolving beyond traditional diagnostic spaces, driven by advances in translational research, molecular diagnostics, and biomanufacturing with less familiar requirements. This session unpacks increasingl…Healthcare Clinical laboratory environments are evolving beyond traditional diagnostic spaces, driven by advances in translational research, molecular diagnostics, and biomanufacturing with less familiar requirements. This session unpacks increasingly complex current and emerging laboratory typologies – including Biosafety Level (BSL) laboratories, current Good Manufacturing Practice (cGMP) facilities, and polymerase chain reaction (PCR) environm…Healthcare Clinical laboratory environments are evolving beyond traditional diagnostic spaces, driven by advances in translational research, molecular diagnostics, and biomanufacturing with less familiar requirements. This session unpacks increasingly complex current and emerging laboratory typologies – including Biosafety Level (BSL) laboratories, current Good Manufacturing Practice (cGMP) facilities, and polymerase chain reaction (PCR) environments – now appearing within academic medical centers, community hospitals, and hybrid clinical-research settings. Through a multi-disciplinary team perspective, the presentation examines the primary regulatory and operational triggers that elevate laboratory classification and complexity. Attendees will gain clarity on how biosafety requirements, process flows, air change rates, pressure relationships, system and material selections, and utility redundancies intersect to drive compliance obligations under standards such as CDC/NIH, FDA, and applicable building and life-safety codes. The session will outline best-practice planning strategies, common pitfalls encountered during design and construction, and practical coordination methods across architecture, engineering, and laboratory stakeholders. The presentation concludes with a summary framework for evaluating laboratory systems holistically – supporting safer operations, long-term adaptability, and regulatory readiness in next-generation healthcare laboratory environments.Show MoreClick the title to see all detailsShow More
