Sterile Compounding (USP 797/800)

Summary

Attend our Sterile Compounding (USP 797/800) Virtual Training for Health Systems course and learn how you and your designated person(s) can meet USP 797 standards through interactive training.

This course is intended for the designated person(s) in your organization to learn through demonstrations from our onsite experts, case—based learning, tool kits and take—home action items.

What attendees will walk away with:

• How to perform a CAPA for identified deficiencies
• Proper review of certification report
• How to perform HD and non-HD competency assessments

If optional day of environmental qualification is added on, you'll also learn:

• How to create an environmental monitoring sampling map
• How to perform air and surface sampling, and tracking and trending of environmental monitoring results

Who this is best suited for:

• Designated persons and assigned trainers who will be doing training and observations

What's covered:

• Didactic training covering key topics:
  • Chapters 797/800 scope; patient safety; roles (DP/Oversight/AT); SOP alignment & annual review
  • Formal QA/QC elements; complaint/incident handling
  • CSP categories and BUD assignments; required elements of the MFR/CR; version control
  • Environmental monitoring: sampling plans, incubation and action planning
  • Certification scope and report review
• In-depth discussion and observational experience with implementation of USP 797 and USP 800
  • CAPA tools
  • Competency assessments and observations
  • Certification report review
• Optional Environmental Monitoring Qualification Day
  • Create sampling maps for your space
  • Complete qualification to perform air and surface sampling
  • Understand how to read and interpret plates
  • Trend your data

ACPE hours applied for

Interested in Nonsterile Compounding (USP 795/800) Virtual Training? Click here to learn more.

Pricing

Agenda

Day 1	USP <797> Foundations, Program Building and Introduction to Quality
8:00 AM	Welcome, Introductions & Training Overview
8:30 AM	Session 1: The Designated Person — Roles, Responsibilities & Accountability
9:30 AM	Session 2: Introduction to QA/QC Concepts and DP Role
10:30 AM	Break
10:45 AM	Session 3: SOP Framework: Development, Revision and Review
12:00 PM	Lunch
12:45 PM	Session 4: Building a Written Personnel Training Program
12:45 PM	Session 5: Certification Report Review - DP Responsibilities and Use of a Certification Checklist
3:15 PM	Break
3:30 PM	Session 6: Cleaning and Disinfection of Sterile Compounding Areas
4:30 PM	Day 1 Wrap-Up, Q&A & Preview of Day 2

Day 2	USP <797> Advanced Topics and Quality Systems
8:00 AM	Welcome Back & Day 1 Recap
8:30 AM	Session 7: CSP Categories & Beyond-Use Dating: Evaluation and Application of Data
10:00 AM	Break
10:15 AM	Session 8: Master Formulation Records, Compounding Records & CSP Labeling
12:00 PM	Lunch
12:45 PM	Session 9: Release Testing — Sterility, BET & Visual Inspection
2:00 PM	Break
2:15 PM	Session 10: CSP Handling, Storage, Packaging & Transport
3:15 PM	Session 11: QA/QC Programs, CAPA, Complaints & Recalls
4:30 PM	Day 2 Wrap-Up, Q&A & Preview of Day 3

Day 3	Optional Virtual Qualification: Environmental Monitoring
8:00 AM	Welcome Back & Day 2 Recap
8:30 AM	Session 12: USP 〈800〉 Overview: Scope, HD Drug List & Types of Exposure Facilities, Engineering Controls
9:45 AM	Break
10:00 AM	Session 13: How to create an HD Assessment of Risk
11:15 AM	Session 14: Personnel Training for HDs: PPE, Hazard Communication and DDCD
12:15 PM	Lunch
1:00 PM	Session 15: Spill Management & HD Wipe Sampling
2:15 PM	Break
2:30 PM	Session 16: HD Receiving, Storage, Labeling, Transport & Disposal
3:30 PM	Session 17: Building a Roadmap to Compliance
4:30 PM	Final Wrap-Up, Action Planning & Adjourn

 

Speakers