Sterility Assurance Training

Protect Patients from Potential Contamination. Reduce the Possibility of Regulatory Scrutiny.

CE Eligible

PCCA Learning Center ▪ Houston, TX

Hands-On Training

Summary

Develop your system to protect patients and be prepared for regulatory inspections through monitoring, collecting, analyzing and responding to data on your facilities, personnel and procedures. Taught in our fully reengineered, next-level training lab by pharmacists and scientific experts with real-world experience, this 4-day course will teach you how to:

  • Integrate USP General Chapter 797, FDA guidance documents, federal law along with other relevant guidelines and USP chapters
  • Interpret observations identified in recent inspections and learn how to avoid them
  • Examine the science behind best practices
  • Qualify attendees performing the competencies found in the latest USP General Chapter 797
  • Examine your practice from the ground up and develop systems to routinely evaluate, monitor and investigate the data generated

Workstations include laminar flow hoods and biological safety cabinets, as well as sterile compounding equipment.

CE = 30 Hours LIVE (PLUS 22.25 to 27.5 Hours HOME STUDY CE Provided by ASHP)

PCCA Sterility Assurance Training is a PTCB-Recognized Education/Training Program (REP) for the PTCB Certified Compounded Sterile Preparation Technician® (CSPT®) Certification. PTCB requires applicants for CSPT to complete a PTCB-REP for their chosen credential, except when they select another pathway to eligibility. REPs have been reviewed and found to provide learners with foundational knowledge that will help them be successful on PTCB exams.

Course Prerequisite

Completion of CORE Compounding Training (or a PCCA equivalent course) is required, or you will be asked to sign a Pre-Qualification Release Form prior to class participation.

Credit & Certificate of Completion Requirements

  1. The ASHP pre-class coursework must be completed prior to attending the hands-on lab training in Houston.
  2. Home study CE will be provided by ASHP (up to 27.5 CE hours for pharmacists, and up to 22.25 CE hours for technicians).
  3. To obtain live CE and receive a certificate of completion, you must attend the live course in Houston, Texas in its entirety (30 CE hours for pharmacists and technicians).

Pricing

Member Price
$3,995* Per Attendee
*Includes $500 for required ASHP home study course materials.

Agenda

Day 1 All times listed are Central Time
8:00 AM Welcome and Introductions
8:45 AM Why Sterility Assurance? Part 1
9:30 AM Break
9:45 AM Why Sterility Assurance? Part 2
  • Review of USP 797 Category 1,2 & 3 Sterile Preparations
10:30 AM Personnel: Limiting Their Contamination
12:00 PM Lunch
12:30 PM

Lab: Competencies

  • Gowning, Garbing, Hand Washing
  • Fingertip Sampling
  • Cleaning and Sanitizing
  • Air Flow
2:00 PM Break
2:15 PM Facilities: Creating an Appropriate Environment for Aseptic Processes
3:30 PM Prevention of Facility Contamination Through Cleaning and Disinfecting
4:30 PM Q&A
4:45 PM Adjourn
Day 2 All times listed are Central Time
8:00 AM Evaluation, Monitoring and Certification of the Facility
9:30 AM Break
9:45 AM The Importance of Effective Documentation and Data Trending
10:45 AM Staging and Aseptic Technique Discussion
11:30 AM Tour of PCCA
12:15 PM Lunch
1:00 PM

Lab: Sterile-to-Sterile Manipulations

  • Workflow
  • Cleaning and Staging in a Sterile Environment
  • Aseptic Technique: Maintaining Proper Technique Throughout Manipulations
    • First Air Hand Placement
    • Hand Washing and Garbing
    • Needle Selection
    • Vial and IV Bag Manipulations
    • Qualifying Aseptic Techniques
    • Qualifying Cleaning Processes of ISO 5 Area
3:00 PM Break
3:15 PM Lab: Continuation
5:00 PM Adjourn
Day 3 All times listed are Central Time
8:00 AM Review and Q&A
8:15 AM

Sterile Formulation Considerations – Part 1

  • Best Practices
  • USP Requirements
  • Federal Law Requirements
  • FDA Guidances
  • Minimum Accurate Weighable Quantity (MAWQ)
  • Compounded Sterile Preparation Calculations
10:00 AM Break
10:15 AM

Sterile Formulation Considerations – Part 2

  • Methods of Sterilization and Packaging
    • Validation of Equipment (IQ)/Operational Qualification (OQ)/Performance Qualification (PQ)
    • Dry Heat Oven
    • Autoclave
    • Filtration with Integrity Test
  • Preservative Content, Appropriateness and Packaging
  • BUDs
12:15 PM Lunch
1:00 PM

Lab: Nonsterile-to-Sterile Manipulations

  • Technique and Processes
    • CVE Use
    • Staging, Moving ISO to ISO
    • Hand Washing and Garbing Transitioning from Room to Room
    • Filtration, Filter Choice
    • Bubble Point
  • Ophthalmic Ointments
    • Technique
    • Packaging
  • Media Fill
4:45 PM Adjourn

Day 4 All times listed are Central Time
8:00 AM Tour of Eagle
8:45 AM Buses Depart Eagle for PCCA
9:00 AM

Quality Assurance and Quality Control: The Why and the How

  • Complaint Handling
  • Adverse Event Reporting
  • Investigations
  • CAPA Process
  • Root Cause Analysis
10:30 AM Break
10:45 AM

Lecture: USP 800 – The Sterile World

  • Requirements: Garb
  • Changes to Ante-Room: Different ISO Classifications
  • Changes in Hand Positions: From Laminar to Vertical Air Flow
  • FDA’s Interest in Cross Contamination Prevention
  • USP 800 Compliance Considerations
12:15 PM Lunch
1:00 PM

Lab: USP 800

  • Oil Injections
    • Processes
    • HD 800 Considerations, ISO to ISO Movement, Gowning and Doffing
    • Technique for Laminar Flow vs. Vertical/Hand Position
    • Filter Choice
3:45 PM Break
4:15 PM Wrap-Up and Qualification Discussion
4:45 PM Adjourn

Speakers

Jerra Banwarth, RPh, FAPC

Annie DeReese, PharmD

Catherine Henderson, PharmD, PCCA Clinical Compounding Pharmacist

Matt Lester, RPh, MBA, PCCA Clinical Compounding Pharmacist

Matt Martin, PharmD, BCSCP

Celeste Zizzamia, PharmD, BCSCP

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.