Demonstrate donning and doffing, hand hygiene, aseptic manipulations and sanitization techniques |
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Demonstrate the use of closed system transfer devices for hazardous drug compounding |
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Prepare compounded sterile preparations in an ISO classified three-room cleanroom suite |
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Solve adjustment calculations for drug form and certificate of analysis-related indications |
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Solve overage calculations for processing, sterility and endotoxin testing |
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Sketch a cleanroom suite for optimal workflow |
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Complete a Master Formulation Record |
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Explain how to perform the gloved fingertip and thumb sampling and a media-fill test |
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Describe findings of a risk assessment, and then construct a corrective action and preventive action plan |
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Describe findings following an inspection, and then construct a corrective action and preventive action plan |
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Operate electromechanical equipment (e.g., balance, automated compounded devise, particulate samplers (non-viable and viable), incubator, sterilizers (steam and dry heat), biological indicator and chemical integrator, pH meter, and more) |
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