Sterile Compounding: Certificate Program
This hands-on program will take the participant through a series of sixteen one-hour workstations as they perform various functions essential for sterile compounding, such as media-fill tests, aseptic techniques for non-hazardous and hazardous drug compounding, designing facilities for optimal workflow, performing calculations for sterile compounding, working with automated compounding devices, detailing master formulation records, and preparing four sterile medications in a state-of-the-art ISO certified three-room cleanroom suite.
Course description
The Home Study component of this activity addresses the fundamentals of quality management, calculations, and principles & techniques surrounding non-hazardous and hazardous compounded sterile preparations.
The Live Training component transforms theory into practice, bringing standards of practice to life. Setting the stage, an opening presentation brings to the forefront key elements of qualification, quality assurance, and quality control. Following this, over 2.5 days, participants will rotate through a series of sixteen one-hour workstations as they rehearse the role of compounder, designated person, inspector, and cleanroom designer. Participants will perform media-fill tests, practice aseptic techniques for non-hazardous and hazardous drug compounding, design facilities for optimal workflow, perform calculations for sterile compounding, work with automated compounding devices, detail master formulation records, self-inspect, apply different technologies, and prepare four sterile medications in a state-of-the-art ISO certified three-room cleanroom suite.
Course format
Home Study (30 hours) with learning assessment that reviews fundamental principles of sterile compounding in preparation for the live event.
Live Training (20 hours in 2.5 days) consisting of sixteen 1-hour rotating small-group workstations where you will practice and be assessed for competency on various functions essential for sterile compounding.
Intended audience
Pharmacists, pharmacy technicians, pharmacy managers, and quality assurance & control officers looking for hands-on, practical training in sterile compounding.
Learning objectives
Pharmacists
- Demonstrate donning and doffing, hand hygiene, aseptic manipulations and sanitization techniques
- Demonstrate the use of closed system transfer devices for hazardous drug compounding
- Prepare compounded sterile preparations in an ISO classified three-room cleanroom suite
- Assess and perform adjustment calculations for drug form and certificate of analysis-related indications
- Perform overage calculations for a compounded sterile preparation
- Sketch a cleanroom suite for optimal workflow
- Complete a Master Formulation Record
- Explain how to perform the gloved fingertip and thumb sampling and a media-fill test
- Summarize findings of a risk assessment, and then construct a corrective action and preventive action plan
- Summarize findings following an inspection, and then construct a corrective action and preventive action plan
- Operate electromechanical equipment (e.g., balance, automated compounded device, particulate samplers (non-viable and viable), incubator, sterilizers (steam and dry heat), biological indicator and chemical integrator and pH meter)
Pharmacy technicians
- Demonstrate donning and doffing, hand hygiene, aseptic manipulations and sanitization techniques
- Demonstrate the use of closed system transfer devices for hazardous drug compounding
- Prepare compounded sterile preparations in an ISO classified three-room cleanroom suite
- Solve adjustment calculations for drug form and certificate of analysis-related indications
- Solve overage calculations for processing, sterility and endotoxin testing
- Sketch a cleanroom suite for optimal workflow
- Complete a Master Formulation Record
- Explain how to perform the gloved fingertip and thumb sampling and a media-fill test
- Describe findings of a risk assessment, and then construct a corrective action and preventive action plan
- Describe findings following an inspection, and then construct a corrective action and preventive action plan
- Operate electromechanical equipment (e.g., balance, automated compounded device, particulate samplers (non-viable and viable), incubator, sterilizers (steam and dry heat), biological indicator and chemical integrator, pH meter, and more)
Testimonials
“Having recently taken a position in a hospital setting, I decided to build on my basic knowledge of sterile compounding. I chose LP3 Network again, in my opinion, they are recognized as experts in this facet of pharmacy, and justifiably so. I highly recommend this program to any person who has the desire to excel in their compounding skills, because you can only be one of the best, if you learn from the best.”
“The course provided me with valuable, relevant and applicable information on sterile compounding in the comfort of a beautiful practice site. The combination of highly knowledgeable instructors, didactic written materials, hands-on-practical experience in a state-of–the-art lab that reflects a matrix of sterility with sparkling glass and mirrors throughout, provided me with one of the finest programs in my 30+ year career. I came away with having a proactive, rather than reactive approach to the preparation of compounded medications. My confidence has been 'compounded', no pun intended!
Pauline A. D’Chiutiis | Pharmacist
“What a wonderful program! The instructors use different types of learning throughout the entire program to grab the attention of every type of learner, through lecture, hands-on, and peer education. The practical component puts all the literature into perspective and the instructors teaching this course are absolutely A1!
Stephanie Armstrong | Pharmacy Assistant
Financial support
This learning activity has received financial support from MEDISCA in the form of an educational grant.
Copyright
This CE Activity is Copyright © 2006-2024 LP3 Network.