Devonne Moore, Pharmd Email & Phone Number

United States

• Transitioned to this role after KabaFusion acquisition of Lincare Home Infusion division• Accreditation Commision for Health Care (ACHC) preparedness team member readying pharmacies for inspection to the applicable home infusion standards• Leadership Compounding Forum member proposing best practices in sterile compounding• Updated competency documentation including hand hygiene and garbing, aseptic technique, and cleaning practices• Prepared a presentation on insanitary conditions and the importance of a properly maintained cleansuite environment• Developed and implemented necessary plans of correction in response to outside inspections and internal audits• Managed third-party vendor cleansuite certifications and reports to ensure rooms meet all necessary specifications

United States

• Regulatory oversight for 21 different home infusion pharmacy locations in 11 states• Performed internal audits of cleanroom practices and aseptic technique to ensure compliance with USP <797> and USP <800>• Updated policies and procedures to reflect new USP <800> standards and was part of the pharmacy roll out team to implement new processes.• Used experience from cGMP facilities as well as USP <797> knowledge to implement best practices including improving cleanroom work flow• Obtained multi-state pharmacist licensure• Provided pharmacist coverage as needed for multiple sites including production and clinical monitoring of patients

United States

• Evaluated, selected, and ordered equipment and consumables (e.g., WFI system, filter integrity tester, mixing apparatus)• Ensured continued compliance with boards of pharmacy and FDA cGMP production guidelines• Reviewed batch records, applicable test results and environmental/personnel monitoring for product release• Wrote SOPs, batch records, and validation protocols for new products and processes• Served as SME for all existing process changes and SOP updates• Assessed production schedule and distributed workload appropriately to ensure completion

Columbia, South Carolina Area

• Formulation pharmacist for Nephron’s 503B Outsourcing Facility • Worked with a team to develop formulation methods for introduction of new product launches including scheduled and list I chemicals• Reviewed batch records to ensure cGMP and GDP compliance• Determined root cause and supervised the resolution of exception batches for release• Focused on aseptic technique and strategies to mitigate common formulation issues

Tampa/St. Petersburg, Florida Area

• Supervised all sterile and non-sterile compounding; USP <797>,< 71>, <85>, and <795> expert level proficiency• Monitored USP <797>, USP <800>, various state board recommendations and FDA guidances for changes and proposed changes to maintain compliance• Maintained non-resident pharmacy licensure for multiple states• Performed high risk production forecasting, formulation development, and extended beyond use date testing development• Implemented Simplifi 797 improving adherence to tasks and reporting• Led PCAB and NABP VPP inspections to positive outcomes