Whether you're fully compliant or just getting started, you can learn more about pharmacy best practice and USP compliance through attending the STAR Center course, Compliance Tools and Aseptic Certification for USP <797>. Participants earn 21 hours of CE credit, including one (1) hours of law credit.
Hands-On Training for Practical Compliance to USP Chapter <797> Guidelines
"Very knowledgeable & experienced instructors! I was very impressed! Great interaction & follow-up to questions. I would recommend this course to anyone involved in IV compounding, training, and management.
"This course was extremely informative ~ very EYE-OPENING!" ~ Julie M., St. Joseph's Health Centre, Toronto, ON
Led by Subject Matter Experts Including:
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Eric S. Kastango: MBA, RPh, FASHP, Founder and President of Clinical IQ, LLC
>Lawrence Trissel: RPh, FASHP, President of TriPharma
>Jim Wagner: President, Controlled Envrionment Consulting
SEMINAR DATES (2008):
*March, April and June 2008 Compliance Tools and Aseptic Certification for USP <797> course are currently sold out.
24 – 26 March*26– 28March*22 –24April*17 – 19June*
19 – 21 August 21 – 23October11 – 13November
PROGRAM OBJECTIVES:
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Learn the facility and environmental requirements for compounding sterile>
products in compliance with USP <797>>
Understand how primary and secondary engineering controls contribute to>
airflow velocity, direction and ultimately ISO classification>
Understand best and worst practices of aseptic technique>
Demonstrate proper handwashing and gowning requirements>
Practice aseptic technique in LAFWs and isolators in a cleanroom environment>
Perform a media fill challenge>
Determine the key issues to manage a cleanroom contractor successfully>
Discuss proper people and product movement and workflow in anteroom>
and cleanroom areas>
To learn more about the history of sterile compounding in pharmacy practice>
and the role of training in pharmacy compliance and practice excellence,PROGRAM GOALS:
The Compliance Tools and Aseptic Certification for USP <797> training modules educate pharmacy and IV managers on how to implement cleanroom principles and practices that comply with USP 797 and industry best practice. Classes are taught in a state-of-the-art facility designed for cleanroom and pharmacy practice demonstration. Topics covered include cleanroom physical design and layout, engineering controls and airflow science, media fill testing, and principles associated with workflow, cleaning, monitoring, validation, staff training and documentation. Attendees completing this program will understand the principles of a USP 797-compliant facility and how to work in such a facility. Participants will take home sample templates for policies, procedures and documentation that can be customized to their facilities’ needs.
TARGET AUDIENCE:
The Compliance Tools and Aseptic Certification for USP <797> is a two-and-a-half day course designed to provide practical experience such that USP <797> requirements can be successfully implemented in a healthcare setting. Pharmacists and technicians with lead responsibility, IV pharmacy managers and other persons involved in facility/cleanroom design or environmental controls will benefit from taking this course. Faculty includes subject matter experts in USP <797> process, environmental consulting, pharmacy training, microbiology, beyond use dating, and stability studies.
WHAT'S INCLUDED:
The program includes two-and-a-half days of intensive, interactive training (including media fill experience); copies of the program presentations; supplemental handouts and
a set of policy and procedure templates. Participants will be provided a light continental breakfast each morning, lunch on both full days, midmorning and afternoon refreshments, a networking dinner and an exhibitor reception.
SPECIAL FEATURES:
Participants are invited to attend a group dinner the first evening of the program, providing an opportunity for networking and sharing information and ideas with the instructors and other participants. An optional exhibitor reception the second evening of the program provides participants with the opportunity to experience hands-on demonstrations of equipment and discuss the relative features and benefits for compounding sterile products. All participants will have the opportunity to receive coupons from program sponsors for equipment, software and services.
ACPE ACCREDITED:
The Compliance Tools and Aseptic Certification for the USP <797> program is approved for 21 hours of CE credit or 2.1 Continuing Education Units (CEUs) by Educational Review Systems (ERS). ERS is accredited as a provider of continuing pharmacy education by the Accreditation Council for Pharmacy Education (ACPE). Certificates will be awarded to all participants who attend the entire program and complete the evaluation form.
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