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USP Educational Workshops (2 day event): Practical Application of USP's General Chapter <797>

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Location: USP Headquarters–Rockville, Maryland

PROGRAM OVERVIEW

USP <797> workshops will provide in-depth analysis of current compounding issues and insight into pharmacy-related content from the USP Pharmacists' Pharmacopeia and the USP–NF. The workshops will focus on the application of USP General Chapter <797> Pharmaceutical Compounding – Sterile Preparations, and feature USP expert committee members and staff to provide guidance and address questions regarding the intent of the chapter. These workshops will also provide a forum for discussion of the current issues affecting facilities and practitioners.All workshops will be ACPE accredited.

Key items to be covered during the 2-day workshops include:

Hands on training on facility designs, media fill test procedures, types of isolators, and clean rooms
Developing a time line to meet the official date
Facility's design and placement of primary engineering controls
Clean room, buffer area, and ante room
Compounding aseptic isolator (CAI)
Compounding aseptic containment isolator (CACI)
Developing gap analysis
CSP Microbial Contamination (low, medium, and high risk levels and 12 hour beyond use dating)
Specialty Compounded Sterile Preparations (CSPs)
Single-dose and multiple dose containers
Immediate use
Sterilization methods (sterilizing high-risk CSPs)
Personnel cleaning and garbing
Developing and implementing SOPs
Disinfectants and cleaning
Environmental quality and control
Verification of compounding accuracy and sterility

Hands-On Breakout Sessions: Four breakout sessions covering environmental monitoring, contamination control, environmental control, and aseptic challenge tests will provide attendees with practical experience on key <797> components.