This presentation will include a moderated Q&A conversation with Kill Shot Author, Jason Dearen. Recently published in February, 2021, Kill Shot tells the frighteningly true story of the events surrounding the worst modern day compounding public health catastrophe: the 2012 fungal meningitis outbreak which led to 64 deaths and over 700 cases of infection as a result of contaminated steroid injections from the New England Compounding Center. NECC failed to follow regulatory guidances, compounding standards, and violated its state board of pharmacy license. It failed to conduct appropriate monitoring for sterility, potency of finished sterile products, and failed to appropriately maintain the environment for manufacturing sterile drugs. Environmental monitoring (EM) is the cornerstone of all compounding and manufacturing quality programs. Pharmacy and manufacturing cleanrooms operating within the scope of USP <797>/<800> or FDA cGMP are held to extremely high standards for environmental monitoring and must establish a routine EM sampling program. Facilities must also establish administrative and engineering controls as the foundation of the EM program, Quality program, and overall compounding and manufacturing.
WorkingBuildings industry professionals have deep expertise in facility design, HVAC and engineering controls, pharmacy operations, and regulatory compliance and can assist your facility with program compliance.
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