Workshops: Practical Application of USP's General Chapter <797>

Course Description

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.

Agenda  (49KB)

Who Should Participate

Healthcare practitioners, particulary compounding professionals; regulatory/accrediting bodies; engineers, architects, environmental quality certifiers; and vendors of clean-room products and services

Format

2- Day Workshop

Location / Date

USP Headquaters – Rockville, MD

  • March 31–April 1 – (Monday-Tuesday)
  • April 17–18 – (Thursday-Friday)
  • May 22–23 – (Thursday-Friday)

Hotel Accommodations

Fees

US $495 per person (Regular Rate)
US $450 per person (Early Bird – up to 21 days before program date)
US $400 per person (Group Rate = 3 or more individuals from the same organization)

Registration

Content to be Covered

  • Hands on training and/or video 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 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
  • Training employees

Please note that the workshops will have sessions providing hands on training relating to some of the key items listed above in addition to an extensive question and answer session with faculty members.