With increasing regulatory focus on compounding practices, the designated person (DP) plays a critical role in maintaining compliance, quality and patient safety. This webinar provides a practical, standards-based overview of what it truly means to serve in this position within both nonsterile and sterile compounding environments.
PCCA Clinical Compounding Pharmacist Matt Lester, RPh, MBA, BCSCP, will walk through the responsibilities outlined in USP 795, 797 and 800, clarifying expectations for oversight, documentation and program management. Attendees will explore best practices in environmental monitoring, staff training and quality systems, along with real-world scenarios that bring compliance principles to life. The session will also cover how to establish effective SOPs and QA/QC programs, and how to confidently prepare for regulatory inspections and audits.
Learning Objectives
- Review DP responsibilities stated in USP 795, 797 and 800 standards.
- Examine the definition, qualifications and responsibilities of the DP in nonsterile and sterile compounding.
- Define best practices in environmental monitoring, documentation and staff training.
- Apply real-world scenarios of compliance principles.
- Recall requirements for SOPs and a formal, written QA and QC program.
- Describe how to prepare for regulatory inspections and audits.
Who Should Attend
Compounding pharmacists, technicians, designated persons and QA/QC leads
Speakers
- Matt Lester, RPh, MBA, BCSCP, PCCA Clinical Compounding Pharmacist