Newnan, Georgia
Individuals attending the course in place of the registered individual will be honored as long as the request is made in advance of the registration deadline, which is 14 days prior to the start of the live component. Transfer participants must still complete the required pre-requisite self-study by the required cut-off date.
Refund requests are subject to a $200.00 cancellation fee and must be received 30 days prior to the start of the live component. All registration cancellations must be submitted in writing or by e-mail to the Continuing Education Department at the following address.
Continuing Education
Email: ce@SCCP.sc.edu
- Operating System: Windows XP SP2 or later, Windows Vista, Windows 7, Mac OS X 10.5 or later
- Internet Browser (Mac &/ Windows): Internet Explorer 7 or later, Firefox 3.5 or later, Safari 4
- Broadband Internet connection: Cable, High-speed DSL & any other medium that is internet accessible
- Peripherals: Computer speakers or headphones
- Monitor Screen Resolution: 320 x 480 or higher
- Media Viewing Requirements: For some components, the most up-to-date version of Adobe Flash may be required. To obtain the free Flash plug-in, go to http://get.adobe.com/flashplayer/.
Date: May 18, 2015 08:00 AM - May 19, 2015 05:15 PM
Fee
CE Hours
CE Units
Registration closes on May 11, 2015 11:00 PM
Activity Type
- Certificate-Based
Target Audience(s)
- Pharmacy Technicians
Accreditation(s)
The University of South Carolina College of Pharmacy is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education.
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Support/Credits
Time
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Session
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Format
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8:00-8:15am
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Registration, welcome, introductions
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8:15-9:15am
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Introduction to Sterile Compounding
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Lecture
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9:15–10:15am
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Overview of USP<797>
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Lecture
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10:15-10:30am
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Break
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10:30-11:15
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Hand Hygiene, Personal Protective Equipment, Garbing
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Lecture
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11:15-noon
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Fingertip Sampling, Hand Hygiene, Garbing
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Lab
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12:00-12:45
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Lunch
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12:45-1:45pm
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Overview of supplies and equipment necessary for sterile compounding
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Lecture/Demo
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1:45-2:30pm
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Primary and Secondary Engineering Controls
LAFW; Cleaning/Disinfecting LAFW
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Lecture/Demo
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2:30-2:45pm
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Break
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2:45 – 4:45pm
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Exercise 1:
Garbing, hand hygiene competency
Gloved fingertip sample competency
Cleaning/Disinfecting LAFW competency
Exercise 2:
Surface Sampling Demo
Particle Generation Demo
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Lab
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4:45-5:15pm
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Review of Relevant Calculations for Sterile Compounded Products
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Lecture/Lab
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5:15-5:30pm
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Review, discussion, observations
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Time
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Session
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Format
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8:00-9:15am
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Discussion of Low/Medium risk sterile compounding and aseptic technique
Hands on simulation - Vial pressure
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Lecture/demo
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9:15– 11:15am
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Smoke Testing (Demonstration of 1st air)
Hands on training of Low/Medium risk sterile compounding & aseptic technique
(15 min break as participants finish exercises)
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Lab
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11:15-12:15pm
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Compatibility/Stability, Beyond-Use-Dating exercises, Documentation,
Quality Assessment/Control for CSP
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Lecture/Demo
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12:15p-1:00p
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Lunch
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1:00-2:00pm
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Environmental Cleaning/Disinfection Documentation Requirements
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Lecture
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2:00-4:30pm
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Review of Fingertip Sample preliminary results and remediation (if needed)
Exercise 1: Assessment of Student Skills in Low/Medium Risk Sterile Compounding and Aseptic Technique (Media Fill)
Exercise 2: Demo of Environmental cleaning processes/product review & documentation
(15 min break as participants finish 1st exercise)
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Lab
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4:30-5:00 pm
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Special Topics – Hazardous Drugs
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Lecture
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5:00-5:15pm
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Wrap up, Q&A
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• Describe the advantages and disadvantages of different parenteral routes
• Identify USP<797> requirements for the training and evaluation of preparers of CSPs as well as the
responsibilities of personnel
• Discuss the difference between primary and secondary engineering controls
• Define ISO classifications 5, 7, and 8
• Describe the layout of a typical clean room, define ante area and buffer area
• Examine supplies used for CSPs and identify factors that influence selection
• Explain manipulations for accommodating positive and negative pressure
• Apply understanding of critical sites and airflow in sterile compounding
• Perform the steps for proper transfers and handling of sterile preparations
• Demonstrate proper techniques to aseptically attach needle to syringe, withdraw contents from vial and ampule, reconstitute vial, and inject into IV bag following all USP <797> guidelines and utilizing appropriate aseptic technique
• Demonstrate proficiency in aseptic technique as it relates to the preparation of different CSPs
• Demonstrate proper garbing procedure, hand hygiene and proper cleaning/disinfecting processes
• Demonstrate accuracy in basic calculations related to the preparation of different CSPs
• Conduct a “media fill test” to assess ability to aseptically compound sterile preparations
• Discuss 3 types of contamination: microbial, chemical and physical
• Differentiate between QA and QC and analyze as it relates to personnel, facilities and monitoring
• Describe special considerations and requirements with preparation of chemotherapy and hazardous drugs
including exposure risks and how to minimize them
- Define parenteral preparations and the role of safety, accuracy and attitude in risk prevention
- Discuss United States Pharmacopeia chapters applicable to pharmaceutical compounding of sterile products
- Define the role of the pharmacy technician and the responsibilities pertaining to sterile compounding
- Describe supplies and equipment used in sterile compounding and the safety considerations
- Summarize the microbiological considerations in sterile compounding and the responsibilities of personnel in preventing contamination
- Classify sterile preparations as low-, medium- or high risks preparation based on their ISO class
- Differentiate between primary and secondary engineering controls and the role they play in sterile compounding
- Describe the critical steps in proper aseptic technique and compounding manipulations
- Distinguish between quality control and quality assurance for sterile compounding
- Identify the key area for monitoring for environment, personnel and end-product testing for a sterile compounding program
- Chapter 1: Pages 1-15 and complete review questions on page 14-15
- Chapter 2: Pages 17-62 and complete review questions and case studies on page 62
- Chapter 4: Pages 107-135 and completer review questions and case study on pages 135-137.
- Chapter 5: Pages 141-171 and complete review questions and case study on pages 171-172. View required video for Chapter 5:
- on Page 148: Cleaning the HLFW (Video length 3:58)
- Chapter 6: Pages 175-220 and complete review questions and case studies on pages 220-222. View required videos for Chapter 6:
- Page 177: Hand Washing (Video length 6:09)
- Page 181: Personal Protective Equipment -Garbing(Video length 0:44)
- Page 181: Personal Protective Equipment-Sterile Gloves (Video Length 1:16)
- Page 189: Attach Needle to Syringe and Remove Cap of Needle (Video Length 0:43)
- Page 190: Enter Vial (Video length 1:02)
- Page 192: Withdraw Contents-equal pressure Milking (Video length 0:53)
- Page 192: Withdraw Contents Reverse Milking(Video length 0:36)
- Page 197: Removal of Air Bubbles (Video length 0:54)
- Page 199: Ampule Breaking (Video length 0:59)
- Page 199: Using A filter needle (1:28)
- Page 199: Using a filter straw (1:31)
- Page 206: Reconstituting Medications for Parenteral Administration (Video length 2:15)
- Page 208: Uncapping and Recapping Needles (Video length 0:38)
- Page 209: Capping a Syringe (Video length 0:51)
- Page 210: Priming an Infusion Set (Video length 2:41)
- Page 211: Positive Pressure (Video length 1:12)
- Page 212: Negative Pressure (Video length 0:50)
- Page 218: Workflow Process (Video length 2:12)
- Page 361: Gloved Fingertip Test (Video length 1:06)
Registration closes on May 11, 2015
at 11:00 PM
Registration Closed
Activity Number
0062-0000-14-094-H04-T
CE Hours
Registration Closed
Speaker(s)/Author(s)
Carl Dunn, RPh
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Carole Small Russell, RPh, MHSA
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Michaela Almgren, PharmD, MS
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Nancy Roberts, PharmD, MS
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