Sterility Assurance Training


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

PCCA Learning Center ▪ Houston, TX
CE Eligible

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 24 to 32 Hours HOME STUDY CE Provided by ASHP)

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 pre-class coursework must be completed prior to attending the hands-on lab training in Houston. Plan to spend 24 to 32 hours to complete the home study material.
  2. The online home study coursework is completed through ASHP's website. Details will be provided upon registration. Home study CE credit will be provided by ASHP.
  3. A certificate of completion and live CE hours will be provided by PCCA upon completion of the in-person program.

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
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 Review and Q&A
8:15 AM Evaluation, Monitoring and Certification of the Facility
9:15 AM Break
9:30 AM The Importance of Effective Documentation and Data Trending
10:45 AM Staging and Aseptic Technique Discussion
11:45 AM Lunch
12:30 PM Tour of PCCA
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
    • Injecting into IV Bag
    • 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)
  • Sterile Math 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
12:45 PM Eagle Analytical Presentation
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
8:45 AM 		Tour of Eagle
Buses Depart Eagle for PCCA
9:00 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
10:00 AM Break
10:15 AM

Lab

  • Oil Injections
    • Processes
    • HD 800 Considerations, ISO to ISO Movement, Gowning and Doffing
    • Technique for Laminar Flow vs. Vertical/Hand Position
    • Filter Choice
1:00 PM Lunch
1:30 PM Clinical Services Meet & Greet
1:45 PM

Quality Assurance and Quality Control: The Why and the How

  • Complaint Handling
  • Adverse Event Reporting
  • Investigations
  • CAPA Process
  • Root Cause Analysis
3:00 PM Break
3:15 PM Quality Assurance and Quality Control: The Why and the How (cont’d)
4:15 PM Wrap-Up and Qualification Discussion
4:45 PM Adjourn

Speakers

Matt Martin, PharmD, BCSCP

Jerra Banwarth, RPh, FAPC

Annie DeReese, PharmD

Jacqueline Esqueda, 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

$3,940.00*

No available classes at this time

* Includes $445 for required ASHP home study course materials. 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. Discounts do not apply to the $445 home study material portion of price.

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.