Usp 797 Expert Witnesses
Usp 797 expert witnesses and consultants listed here may be able to form expert opinions, draft expert witness reports, provide expert witness testimony at deposition and/or trial as or serve as consulting (non-testifying) experts on usp 797. The usp 797 expert witness listings on this page are typically from fields/areas of expertise such as: Pharmaceutical Regulation, Pharmacist, and Pharmacology- Clinical.
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Andrew M. Warther, PharmD
Pharmacy Standard of Care Expert
Andrew Warther Consulting, LLC
Phoenix, Arizona
Pharmacist
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Pharmacy standard of care, Compounding, USP 795, Dispensing errors, Controlled substances DEA, Diversion prevention, Pharmacy negligence, Medical errors, Pharmacist in charge PIC, Board of Pharmacy matters, Pharmacy policies and procedures, Pharmacy operations, Quality assurance, USP 797, USP 800, Sterile, Non-Sterile, Veterinary
I am a PharmD and experienced pharmacy operations and compliance leader with extensive expertise in pharmacy regulatory requirements, pharmacy standard of care, medication-use systems, and quality programs. I provide expert witness services in matters involving pharmacy and pharmacist negligence/standard of care, medication errors, dispensing and verification processes, controlled substance compliance and diversion prevention, policies/procedures (SOPs), documentation and record-keeping, and Board of Pharmacy-related issues.
My professional background includes senior leadership roles overseeing day-to-day pharmacy operations, staffing models, workflow design, training programs, and continuous improvement initiatives. I have led and supported internal audits, corrective and preventive actions (CAPA), root cause analysis, and the development/implementation of quality systems to reduce error risk and improve compliance. I am comfortable reviewing and opining on pharmacy practices, cor...
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Eric Nielsen, PharmD, BCSCP
Board Certified Sterile Compounding Pharmacist
Arden, North Carolina
Pharmacology- Clinical, Pharmaceutical Regulation
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BCSCP, Board Certified, Sterile Compounding Pharmacist, IV medication, Pharmacy Law, Hospital Pharmacy, Infusion Pharmacy, Chemotherapy, Cancer Treatment, Pediatric Pharmacy, Neonatal Care, Labor & Delivery, Standards of Care, USP 797, USP 800, Hazardous Medications, Consultant Pharmacist, Medication Safety, Nursing Home Care
I am a Board Certified Sterile Compounding Pharmacist with more than 12 years of experience in hospital critical care pharmacy and 14 years of experience as a pharmacist, with all 14 years including the preparation of IV medications. I am also a licensed Consultant Pharmacist.
As the IV Program Manager at my hospital system, I'm responsible for compliance with USP chapters, Joint Commission standards, FDA regulations, and VA directives. I’m trusted to set policy for compounding operations, oversee personnel training and performance, and to develop chemotherapy treatment plans. I collaborate with Nursing, Medical, and Pharmacy leadership to promote continuous healthcare quality and safety improvement.
IV route is the most immediate and unforgiving of medication routes. It demands the highest level of diligence from all personnel involved in this type of care. I have seen honest medication errors as well as mistakes made out of negligence. With sufficient facts to reference, I'm ab...