This presentation outlines the roles and responsibilities of the Designated Person(s) (DP(s)) in relation to sterile compounding as established in USP 797. It explores how DP(s) can effectively utilize Standard Operating Procedures (SOPs) and implement strategies to maintain staff engagement and ensure ongoing preparedness for inspections. Through active sharing, observation, and preparation of staff, DP(s) can significantly reduce compliance risks associated with compounding.
Speakers:
• Annie Lambert, PharmD, BCSCP, Clinical Program Manager, Simplifi+ Compliance Solutions, Wolters Kluwer Health
• Lisa D. Ashworth, BS Pharm, RPh, BCSCP, FACA, Independent Consultant, Ashworth Pharmacy Consultants
