Kristopher Le, Pharm.D. Email & Phone Number

Columbia, Sc, Us

AMICUS is a consulting company providing efficient solutions to meet today's regulatory issues. We are a hands-on firm that believes in providing results beyond just “reports only.” At AMICUS, we provide a large range of services to FDA regulated compounders and manufacturers, all designed to meet our client’s specific needs.Our areas of expertise include:GMP Compliance: We provide comprehensive compliance assessments, audit preparation, and remediation services to ensure that our clients' facilities, processes, and systems meet or exceed the FDA's current Good Manufacturing Practice (cGMP) regulations.Quality Systems: Our team helps clients develop and implement robust quality management systems that ensure consistent product quality and compliance with FDA regulations. We provide guidance on all aspects of quality, including document control, change control, deviation management, and CAPA (Corrective and Preventive Action) systems.Validation: We offer validation services that ensure that our clients' equipment, facilities, and processes are qualified to operate within specified parameters and meet regulatory requirements. Our services include equipment qualification, process validation, cleaning validation, and computer system validation.Training: We provide comprehensive training programs to help our clients develop a culture of compliance and ensure that their employees have the knowledge and skills necessary to meet regulatory requirements.Regulatory Affairs: Our team of regulatory experts provides guidance on all aspects of FDA regulatory compliance, including product submissions, labeling, advertising, and post-marketing surveillance.

St. Louis, Missouri, Us

"Improving the compounding and pharmaceutical industry by providing solutions that prevent and resolve compliance issues while fostering operational efficiency and success.”

- Development and implementation of quality systems.- Ensure compliance with CFR 21 Part 210 & 211 as it applies to 503b operations.- Development and implementation of equipment/process validation programs.- Review and development of corrective and preventive action plans.- Investigation and mitigation of non-conformances.- Analysis and development of environmental monitoring programs and qualifications.- Development and implementation of internal personnel training/certification programs.- Development of media-fill process validation for aseptic processing.- Establishment of a stability program to support 503b products.- Business development and marketing of 503b products/services.

- ACPE Certified Sterile Compounder- USP <797> & USP <71> Compliance- USP <795> Compliance- Purchasing/Inventory Management- Product and Vendor Management- Product Development- Regional Expansion- University of Florida College of Pharmacy Preceptor- NOVA Southeastern University College of Pharmacy Preceptor

PRN Clincal Staff Pharmacist-Medication order entry and verification-Manage targeted antibiotic pharmacokinetics-Inpatient glycemic management-Medication Reconciliation

Pharmacist/Pharmacy Operations Manager- Purchasing/Inventory Management- Staffing and scheduling of pharmacy staff- Product and Vendor Management- Manage pharmacy software operation and enhancements- Expanding compounding pharmacy sales and reach- Management of Standard Operating Procedures related to sterile and non-sterile compounded medications-Medication Therapy Management

Nashville, Tn, Us