Sterile Compounding (USP 797/800) Virtual Training for Health Systems

 

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.

ACPE = hours applied for

What's covered:

  • USP Chapters 797/800 scope 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
 
 

Agenda

Self-Paced Day One- prerecorded didactic content at your own pace prior to live virtual training
45 min.

Module 1: Intro to USP & Compounding Standards

USP Chapters 797/800 scope; patient safety; roles (DP/Oversight/AT); SOP alignment & annual review
60 min.

Module 2: Quality Program (QA/QC)

Formal QA/QC elements; complaint/incident handling; RCA/CAPA; USP 1163; documentation & retention
60 min.

Module 3: Non-HD Sterile Compounding USP 797

Engineering controls; HHG/garbing; cleanroom behavior; material transfer; aseptic manipulations; equipment
60 min.

Module 4: HD Sterile Compounding USP 800

HD list & AoR; PPE don/doff; C-PEC/C-SEC; storage; decon/clean/disinfect; wipe sampling; spill basics
60 min.

Module 5: MFR/CR & BUD; Supplies/Components

CSP categories and BUD assignments; required elements MFR/CR; version control
75 min.

Module 6: Environmental Monitoring (Air/Surface)

Viable vs nonviable; sampling plans/maps; incubation/ID; USP 1116/1117; recovery rates vs action levels
90 min.

Module 7: Cleanroom & SCA Certification

Certification scope; CETA regulation; report review checklists; CAPA for failures
30 min.

Knowledge Checks / Quizzes

Short quizzes after modules
Day 2  
8:00 AM Welcome and Introductions
8:30 AM Case Study: Deviation → CAPA Tool
9:00 AM Non-HD Sterile Competencies
11:00 AM Break
11:15 AM MFR/CR Review & CAPA
12:15 PM Lunch
12:45 PM HD Competencies
2:45 PM Break
3:00 PM Certification Report Review
4:00 PM Adjourn
Day 3 Optional Virtual Qualification: Environmental Monitoring
8:00 AM Welcome and Introductions
8:30 AM Environmental Sampling Plan and Mapping
9:30 AM Air and Surface Sampling Technique Validation
10:15 AM Break
10:30 AM Reading Your Plates
11:15 AM Environmental Monitoring Trend Analysis
12:15 PM Break
12:30 PM Documentation & CAPA
1:15 PM Adjourn
 
 

Speakers

Coming Soon

 


This activity is eligible for ACPE credit; see final CPE activity announcement for specific details.

No available classes at this time

CANCELLATION POLICY
Full refunds available through Wednesday, September 16, 2026. No refunds will be provided after September 16 for event cancellations. If you are unable to attend live, you will still have access to view the recorded presentations for 60 days.

MONEY-BACK GUARANTEE
We take great pride in developing the highest quality educational programs and providing top-notch networking and sharing opportunities at our events. More than 98 percent of all attendees give our programs an “A” grade, so we’re confident that you will benefit from program content as well as the helpfulness of staff at every event. However, we want to back this up with more than just words. So our policy is to provide you with a full refund of the purchase price of the program if it hasn’t met your educational goals.

If you are unsatisfied with our education content, your refund must be requested within 14 days of the completion of the program. To request a refund, email education@pccarx.com and include the attendee name, email address, phone number, program attended and a detailed explanation of why a refund is being requested. All refunds will be issued according to the original payment method.