PROGRAM OBJECTIVES:
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 garbing 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
- 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 Aseptic Processing and Compliance Tools 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 Aseptic Processing and Compliance Tools 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 and an exhibitor reception. Upon completion, participants earn 21 hours of CE credits including (1) hour of law credit. Certificates are sent to participants within 6-8 weeks of course completion.
FEATURES:
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 have the opportunity to receive discount coupons from program sponsors for equipment, software and services.
ACPE-ACCREDITED:
The Aseptic Processing and Compliance Tools for 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 are awarded to all participants who attend the entire program and complete the evaluation form.
TRAVEL ARRANGEMENTS:
Participants must make all airline, shuttle and hotel reservations. Upon registration, an information packet is sent that details hotel recommendations and corporate rates. For more information about travel arrangements, contact the STAR Center Coordinator at 877.395.2292 or Send Us An Email.
CANCELLATION POLICY:
Program Cancellation
The STAR Center reserves the right to cancel a program at any time due to a faculty conflict, inclement weather or low enrollment. In the event of a STAR Center program cancellation, registrants will be issued a full refund for the program registration fees only, or be given the opportunity to reschedule for another available class. This cancellation policy applies to all STAR Center Professional Training Programs and Seminars unless otherwise noted on the program’s information page.
Faculty Conflict
In the event of faculty conflict for a scheduled course offering, a cancellation determination will be made no later than 14 business days prior to the start of the scheduled course offering. Every effort will be made to schedule registrants for the cancelled course in the next scheduled course offering, depending on availability. In the event of a STAR Center cancellation due to faculty conflict, registrants will be issued a full refund – for the course registration fees only - or be given the opportunity to reschedule for another available course.
Inclement Weather
In the event of inclement weather, the decision to cancel a course will be made no later than 6:00 am the morning of the program. An attempt will be made to contact all registrants via phone or email upon cancellation. Every effort will be made to schedule registrants for the cancelled course in the next available course offering. In the event of a STAR Center cancellation due to inclement weather, registrants will be issued a full refund – for the course registration fees only – or be given the opportunity to reschedule for another available course.
Low Enrollment
A minimum number of registrants for STAR Center courses are required to cover the operating costs. In the event of enrollment below the minimum for a course, a cancellation determination will be made no later than 14 business days prior to the start of the scheduled course offering. Every effort will be made to schedule registrants for the cancelled course in the next available course offering. In the event of a STAR Center cancellation due to low enrollment, registrants will be issued a full refund – for the course registration fees only – or be given the opportunity to reschedule for another available course.
Transfers
Registration may be deferred one time only to a later scheduled course, depending on availability. All registration transfer requests must be submitted in writing to Baxa Customer Service at customer.service@baxa.com.
Registration transfers – individuals attending the course in place of the registered individual – will be honored up to the program start date, and will be honored on site if the request is provided on company letterhead with the names and titles of both the original registrant and the replacement registrant.
Refunds
Refund requests are subject to a $100.00 cancellation fee. All registration cancellations must be submitted in writing, or by e-mail, to Baxa Corporation at the following address.
Baxa Corporation
Attn: STAR Center Registration/Customer Service
14445 Grasslands Drive
Englewood, CO 80112-7062
FAX: 877.672.0085
Email: customer.service@baxa.com
Registrants may receive 100% of the program registration fees, less the $100 cancellation fee up to 30 business days prior to program start date; 50%, less $100 cancellation fee, between 15-30 business days prior to program start date. No refunds are offered for cancellations fewer than 14 business days prior to program start date, or for no shows.
