USP Implementation Training


Designated Person Training & Compounding Best Practices for 795, 800 and Beyond

PCCA Learning Center ▪ Houston, TX
CE Eligible

Hands-On Training

OPEN TO ALL COMPOUNDING PHARMACIES – PCCA MEMBERSHIP NOT REQUIRED

Summary

Did you know? On November 1, 2022, official USP 795 revisions were published which state that ALL pharmacy personnel must:

  • Be trained initially and annually
  • Be assessed on core competencies initially and annually
  • Have documentation of training and competency

PCCA’s USP Implementation Training will fulfill the USP requirement to train the pharmacy’s “designated person” on how to assess competencies of pharmacists and technicians doing nonsterile compounding. The course will also provide education on how to complete the appropriate documentation of training and other USP requirements.

Taught in a fully reengineered, next-level training lab, this 2-day course teaches attendees how to practically apply USP 795, USP 800 and best practices in day-to-day workflow as well as quality assurance.

DAY 1 provides an in-depth look at:

  • USP 795 changes
  • Competencies
  • Workflow
  • Packaging
  • Beyond-use dating
  • Practical application in your lab
  • Laboratory practicums covering USP 800 requirements

DAY 2 focuses on the pharmacy’s “designated person(s)” as defined in the USP 795 and USP 800 chapters. Attendees will learn:

  • Facility operations
  • SOPs
  • Personnel training
  • Adverse event documentation
  • FDA guidance documents
  • How to assess competencies at the pharmacy
  • Laboratory practicums

During the course, you’ll learn how to use and implement the following provided templates in your QA/QC plan at home:

  • Corrective Action and Preventive Action (CAPA) Template
  • Out of Specification (OOS)/Complaint/Adverse Event (AE) Template
  • Root Cause Analysis (RCA) Template
  • Risk Assessment/Mitigation Template

Now’s the time to prepare for these USP changes. And PCCA can help. Combine USP Implementation with CORE Compounding Training and eLearning Compounding Training for a comprehensive training program for your compounding staff.

CE = 15.5 Hours LIVE (PLUS 8 Hours HOME STUDY CE Provided by NPTA)

Agenda

Day 1 All times listed are Central Time
8:00 AM AM Welcome
8:15 AM AM USP Standards and Quality Assurance (QA)
8:45 AM AM Facilities and Insanitary Conditions
9:30 AM AM Break
9:45 AM AM Practical Application of USP 795 in Your Lab: Standards and Best Practices in Compounding Workflow and Considerations
10:15 AM

Lab Practicum

  • Hand Hygiene and Garbing
  • Cleaning and Sanitizing
  • Handling and Transporting Components and CNSPs
  • Measuring Basics, Thermometer, Beaker, Syringe
  • Geometric Dilution
  • Hood Cleaning
  • Workflow in Hood to Decrease Cross-Contamination
  • How to Use, Clean and Calibrate: Hot Plate and Balance
12:30 PM Lunch
1:00 PM Formula and USP 800 Considerations
3:00 PM Break
3:15 PM Lab: Workflow for USP 800
4:30 PM

Getting CNSPs Out the Door: Standards and Considerations of the Finalized Compound

  • BUD Packaging OOS
  • Adverse Events (AE)
  • Complaints
  • Documentation
5:15 PM Closing Remarks
5:30 PM Adjourn
Day 2 All times listed are Central Time
8:00 AM Welcome
8:10 AM Designated Person (DP) Roles and Responsibilities
8:30 AM

Risk Assessment and Mitigation, QA/QC, Hazardous Communication and CAPA

  • CAPA Discussion
  • Identifying Out of Specification (OOS)
  • When and How to Perform Risk Assessment
  • Formal QA/QC Program with an Established System
9:45 AM Break
10:00 AM Risk Assessment and Mitigation, QA/QC, Hazardous Communication and CAPA (cont’d)
11:00 AM

Facility Operations

  • Engineering and Environmental QC
  • Receipt and Storage
  • Spill Control
  • Component Selection
  • Cleaning and Sanitizing
11:45 AM Tour of PCCA
12:15 PM Lunch
12:45 PM

Lab: Risk Assessment and Mitigation

  • Lab Environment
  • Receipt and Storage
  • Spill Control
  • Component Selection, Cleaning and Sanitizing
1:15 PM Lab Debrief
1:45 PM Break
2:00 PM

Creating and Implementing an SOP

3:00 PM

Personnel Training and Competency Evaluations

  • Training Program Requirements
  • Garbing Requirements and Evaluation
  • Personal Hygiene Requirements and Evaluation
  • Performing Competency Assessments and Documentation
3:45 PM Break
4:00 PM

Lab: How to Evaluate Competencies of a Training Program

  • Evaluating Complaints/AE with Documentation
  • Reporting & Implementing Actions If Necessary
4:30 PM Lab Debrief
5:00 PM

Complaints and Adverse Event (AE) Reporting

  • Documentation and Processes for Complaints/AE
  • Evaluation
  • Reporting and Action
5:30 PM Closing Remarks
5:45 PM Adjourn

Speakers

Jerra Banwarth, RPh, FAPC

Annie DeReese, PharmD

Beau Harger, PharmD

Chris Simmons, RPh

Accommodations

Houston Marriott Sugar Land
16090 City Walk
Sugar Land, Texas 77479-2971
USA
281.275.8400

Click the appropriate link below to book your reservation online.

PCCA Rate: $137/night

Please be sure to make your hotel reservation before the above cutoff dates. After these deadlines, room rates will increase and rooms may not be available.

Attendees are responsible for roundtrip transportation to/from the airport. PCCA will provide transportation to/from the hotel and PCCA facility each day of training.

Pricing

$1,945.00*

No available classes at this time

* Includes $150 for USP Compounding Compendium Online Subscription access and home study. Detailed information will be emailed upon registration.

Discounts listed below apply to multiple attendees from the same pharmacy — of the same course and same course date.

2 attendees = 10% discount
3 attendees = 15% discount
4 attendees = 20% discount
5+ attendees = 25% discount

Additional group discounts available.
Call 800.331.2498 for details.


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

BILLING AND CANCELLATION POLICY
Credit cards will be billed immediately. Any cancellations received after course material is provided will be subject to a $500 cancellation fee. Any cancellations received within 14 days of the class start date, including no-shows, will be charged the full course fee.

MONEY-BACK GUARANTEE
PCCA takes 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 PCCA 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.