Summary
Attend our 2-day Nonsterile Compounding (USP 795/800) Virtual Training for Health Systems course and learn how you and your designated person(s) can meet USP 795 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:
- Evaluating the master formulation record (MFR) and compounding record (CR)
- In-depth discussion and observational experience with implementation of USP 795 and USP 800
- Designated person (DP) role and responsibilities
- Quality assurance, quality control and workflow resources and tools
- Beyond-use date (BUD) assignments and extensions
- Facilities, garbing, hand hygiene and cleaning in nonsterile compounding
- In-depth discussion and observational experience with implementation of USP 797 and USP 800
- CAPA tools
- Competency assessments and observations
- Certification report review
- How to build a training matrix which includes competency assessments
- How to tie everything you’ve learned together so you know what to do when you get back
Agenda
| Day 1 |
|
| 8:00 AM |
Welcome and Introductions |
| 8:30 AM |
Quality System: SOPs, QA/QC, Complaints/Recalls, Transport, DP Annual Review |
| 9:30 AM |
Break |
| 9:40 AM |
People & Practice: Training, Hand Hygiene, Garbing, Observation/Corrective Action |
| 10:40 AM |
Personnel: Limiting Their Contamination |
| 10:50 AM |
Break |
| 11:00 AM |
Place & Process: Facilities, Cleaning/Sanitizing, Equipment, Components |
| 12:00 PM |
Break |
| 12:30 PM |
Records: MFRs, CRs, Release Inspection, Labeling |
| 1:30 PM |
Break |
| 1:40 PM |
BUDs: Assigning and Extending with Water Activity Concepts |
| 2:30 PM |
Capstone: DP Readiness Self-Check and Q&A |
| 3:30 PM |
Adjourn |
| Day 2 |
|
| 8:00 AM |
Competency Program: Training + Observation |
| 9:00 AM |
Break |
| 9:10 AM |
SOP System: Authoring, Implementation, Control |
| 10:10 AM |
Break |
| 10:20 AM |
Components & BUD Diligence |
| 11:15 AM |
QA/QC Program and Annual Review |
| 12:15 PM |
Lunch |
| 1:00 PM |
Real-Time Oversight: Monitoring & Immediate Corrective Action |
| 2:00 PM |
Certification Report Review |
| 3:00 PM |
Adjourn |

This activity is eligible for ACPE credit; see final CPE activity announcement for specific details.
No available classes at this time