Quality Assurance

The Comprehensive Sterile Compounding Certificate Program is a live, in-depth training program designed for pharmacists and pharmacy technicians involved in sterile compounding. This certificate-based course provides a structured, practice-focused review of sterile compounding standards, regulatory requirements, documentation, training, and quality systems to support safe and compliant operations.

Participants will examine the legal and regulatory framework governing sterile compounding, including applicable FDA guidance and key USP standards such as USP <797> and USP <800>. Emphasis is placed on understanding how these requirements translate into daily practice and inspection readiness.

The program includes detailed instruction on documentation, quality assurance and quality control programs, policies and procedures (SOPs), and personnel training and competency requirements. Attendees will review expectations for facility design, environmental monitoring, equipment, and workflow as they relate to sterile compounding compliance.

A focused module on hazardous drug handling addresses facility requirements, engineering controls, PPE, personnel training, and assessment of risk, with alignment to current safety and regulatory expectations.

This certificate program combines didactic instruction and application-based learning, offering attendees the opportunity to strengthen their sterile compounding knowledge while reinforcing compliance, safety, and best practices.