USP Implementation Training

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

CE Eligible

PCCA Learning Center ▪ Houston, TX

Hands-On Training

OPEN TO ALL COMPOUNDING PHARMACIES – PCCA MEMBERSHIP NOT REQUIRED

A 2024 BOGO OFFER YOU CAN’T REFUSE!

Buy 1 USP Implementation Training registration, get 1 FREE registration to that same course date!

Summary

Essential for all quality control officers and “designated persons” within the pharmacy, as well as pharmacists and technicians doing nonsterile compounding, regardless of experience level and prior training. PCCA’s USP Implementation Training fulfills the USP requirement to train the pharmacy’s “designated person” on how to assess competencies of pharmacists and technicians doing nonsterile compounding. The course also provides education on how to complete the appropriate documentation of training and other USP requirements.

While USP minimums require only one designated person per pharmacy, PCCA pharmacy compounding experts recommend a minimum of two designated persons per pharmacy, based on the number and thoroughness of USP-required designated person responsibilities and their impact on compounding staff workload.

Taught in a fully reengineered, next-level training lab, this 3-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.

What’s covered:

  • Current USP 795 regulations and best practices
  • Competencies
  • Workflow
  • Packaging
  • Beyond-use dating
  • Practical application in your lab
  • Laboratory practicums covering USP 800 requirements
  • Designated person(s) training
  • Facility operations
  • SOPs
  • Personnel training
  • Adverse event documentation
  • FDA guidance documents
  • How to assess competencies at the pharmacy

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

Combine USP Implementation with CORE Compounding Training and eLearning Compounding Training for a comprehensive training program for your compounding staff.

CE = 23.5 Hours TOTAL (15.5 HOURS LIVE; 8 HOURS HOME STUDY)

Pricing

Member Price Non-Member/List Price
$2,395* BOGO OFFER $2,995* BOGO OFFER
Buy 1 Registration, Get 1 FREE Registration to the Same Course Date!
*Includes access to USP Compounding Compendium and home study CE materials.

Agenda

Day 1 All times listed are Central Time
8:00 AM Welcome and Introduction
8:15 AM USP Implementation Overview and the Why
8:45 AM Designated Person(s) Roles and Responsibilities
9:10 AM Facilities and Insanitary Conditions
10:00 AM Break
10:15 AM Lab: Insanitary Conditions and Debrief
11:15 AM Practical Application of USP 795 in Lab Workflow
12:30 PM Lunch
1:15 PM Practical Application of USP 795 in Lab Workflow (cont’d)
3:30 PM Break
3:45 PM Formulation Considerations (Master Formula, Compounding Record, Release and Inspection, Labeling)
4:40 PM Wrap-up
5:00 PM Adjourn
Day 2 All times listed are Central Time
8:00 AM Establishing BUDs
8:45 AM Creating and Implementing SOPs
9:45 AM Break
10:00 AM Practical Application of USP 800 in Lab Workflow
11:45 AM Tour of PCCA
12:30 PM Lunch
1:15 PM Lab: Practical Application of USP 800 in Lab Workflow (cont’d)
2:30 PM Personnel Training and Competency Assessments
3:30 PM Break
3:45 PM Lab: How to Perform Competency Assessments
4:45 PM Wrap-up
5:00 PM Adjourn
Day 3 All times listed are Central Time
8:00 AM Welcome
8:10 AM Complaints and Adverse Event Reporting
8:40 AM Advocating for Our Industry
9:00 AM QA/QC and Risk Assessment
9:30 AM Break
9:45 AM Lab: Risk Assessment, Mitigation and Debrief
10:45 AM How to Perform an Investigation and CAPA
11:45 AM Lunch
12:30 PM Lab: Perform an Investigation and CAPA
4:00 PM Wrap-up
4:30 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: $139/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.

No available classes at this time


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.