Sterility Assurance Training

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

CE Eligible

PCCA Learning Center ▪ London, Ontario, Canada

Hands-On Training

Summary

Protect patients from potential contamination. Reduce the possibility of regulatory scrutiny.

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 a mock sterile environment by pharmacists with real-world experience, this 4-day course will teach you how to:

  • Integrate current Canadian regulatory standards and USP 797 guidelines along with other relevant guidance documents and USP chapters
  • Interpret observations identified in recent inspections and learn how to avoid them
  • Examine the science behind best practices
  • Examine your practice from the ground up and develop systems to routinely evaluate, monitor and investigate the data generated

Course Prerequisite

Completion of C3 (Comprehensive Compounding Course)/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:

  • The home study coursework must be completed prior to attending the hands-on lab training in London, Ontario. Plan to spend 24 to 32 hours to complete the home study material.
  • The online home study coursework will be completed through ASHP’s website. The purchase of ASHP home study course material is required, but is included within your registration fee. Details will be provided upon registration. Home study CE credit will be provided by ASHP.
  • A certificate of completion and in-person CE hours will be provided by PCCA upon completion of the in-person program.

CE = 50 contact hours total (30 hours in-person + 20 hours home study)

Location: PCCA, 744 Baransway Drive, London, ON, N5V 5J2 Tel: 800.668.9453

Pricing

Price
$4,095 CAD + tax (Includes ASHP home study course materials.)
Applicable discounts will be applied before billing.

Agenda

Day 1 All times in Eastern Time.
8:00 AM – 4:30 PM
  • Welcome and Introductions
  • Why Sterility Assurance? Parts 1 & 2
  • Personnel Requirements: Limiting Their Contamination
  • Tour of PCCA
  • Lab Competencies: Gowning, Garbing, Hand Washing, Fingertip Sampling, Cleaning and Sanitizing and Air Flow
  • Facility Obligations: Creating an Appropriate Environment for Aseptic processes
  • Prevention of Facility Contamination Through Cleaning and Disinfecting
  • Q&A
Day 2  
8:00 AM – 4:30 PM
  • Review and Q&A
  • Evaluation, Monitoring and Certification of the Facility
  • The Importance of Effective Documentation and Data Trending
  • Staging and Aseptic Technique Discussion
  • Lab: Sterile-to-Sterile Manipulations: Workflow, Cleaning & 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
Day 3  
8:00 AM – 4:45 PM
  • Review and Q&A
  • Sterile Formulation Considerations: Parts 1 & 2
  • Best Practices: USP/Canadian Legal and Regulatory Requirements, Minimum Accurate Weighable Quantity (MAWQ), Sterile Math Calculations
  • Methods of Sterilization and Packaging: Validation of Equipment/Dry Heat Oven/Autoclave/Filtration with Integrity Test, Preservative Content, Appropriateness and Packaging, BUDs
  • 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
Day 4  
8:00 AM – 3:30 PM
  • Review and Q&A
  • Review Contact Plates
  • Hazardous Drugs — The Sterile World: Requirements: Garb, Changes to Ante-Room: Different ISO Classifications, Changes in Hand Positions: From Laminar to Vertical Air Flow, Cross Contamination Prevention, Canadian Regulatory Guidelines/USP Compliance Considerations
  • Lab: Oil Injections: Processes/Hazardous Drug Considerations/ISO to ISO Movement/Gowning and Doffing/Technique for Laminar Flow vs. Vertical-Hand Position/Filter Choice
  • Quality Assurance and Quality Control: The Why and The How: Compliant Handling, Adverse Event Reporting, Investigations, CAPA Process, Root Cause Analysis
  • Wrap-Up and Qualification Discussion

Speakers

Amanda Cassel, BSc (Biology)

Cheryl Hedrick, Territory Manager/Training Specialist

Matthew Lester, RPh, MBA

Matt Martin, PharmD, BCSCP

Accommodations

The Park Hotel London
242 Pall Mall Street
London, ON N6A 5P6
519.642.4444

Click the appropriate link below to book your reservation online.

PCCA Rate: Lifestyle King Suite — Sun-Thurs: $155/night; Fri-Sat: $165/night

Transportation will be provided by Voyageur Shuttle or Checker Taxis. Please watch for your shuttle schedule included in the confirmation of registration.

What Members Are Saying

“Attending PCCA Canadian Sterility Assurance Training has made me understand how deficient our facility is and the improvements that would be required to meet Canadian regulatory standards. Matt did an excellent job of encouraging participants to ask questions and bringing us all back on track; he is very approachable.”

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
Billing will occur prior to the course start date. Any cancellations received following the delivery of the ASHP home study e-learning will incur a $600 cancellation fee. Event no-shows will be charged full course fee of $4,095 CAD + tax.