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STERILE COMPOUNDING BOOT CAMP

Earn 28.75 credit hours (10 hours self-paced eLearning and 19.5 hours of live training)


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Hands-On Training for Practical Compliance with USP Chapter <797>

COURSE REGISTRATION: $3,495
Register 30 days before class to receive $200 early bird discount.

Click Here to Register for an Upcoming Class!

Held at the CriticalPoint Center for Training and Research Facility in Totowa, NJ, this training program delivers high-quality, cost-effective professional development and networking opportunities. We believe that the best way for pharmacists and other compounding professionals to understand and implement current standards of practice is to be immersed in a setting that provides access to a comprehensive curriculum in a real-life setting with hands-on practice mentored by faculty who are truly subject matter experts.

CriticalPoint’s Sterile Compounding Boot Camp™ indoctrinates learners to current sterile compounding best practices through presentation of theoretical and practical information presented in e-learning, classroom and realistic workplace simulations. Once registered, attendees are provided with access to selected CriticalPoint e-learning lessons which must be completed prior to the onsite attendance. Once at the class, learners are presented information to assist them to implement cleanroom principles and practices that comply with USP <797> as well as industry best practices. 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; personnel media fill testing and process validation as well as an exploration of principles associated with workflow, cleaning, environmental sampling, validation, staff training and documentation. Attendees completing this program will gain an understanding of how to develop and implement an operation that meets or exceeds USP Chapter <797> requirements. Participants will take home sample electronic templates for policies, procedures and documentation that can be customized to their facility’s needs.

Learning and Performance Objectives:

  1. Summarize important events in the history of pharmacy sterile compounding and how these have influenced practice standards, sterile compounding regulation, pharmacy education and training as well as quality management
  2. Explain current facility, environmental and personnel metrics requirements for compounding sterile preparations in compliance with USP
  3. Describe how primary and secondary engineering controls contribute to airflow velocity, direction and ultimately ISO classification
  4. Recognize best practices (as well as worst practices) of aseptic technique in your workplace
  5. Perform proper hand hygiene, garbing and gloved fingertip sampling
  6. Describe facility cleaning, material handling and conduct of personnel in controlled sterile compounding environments.
  7. Practice aseptic technique in LAFWs and isolators in a cleanroom environment visualizing first air and gaining an appreciation of how improper technique and material organization can disrupt first air.
  8. Describe documentation of operator and process media fill tests as well as required actions in the event that growth is detected
  9. Explain how, when and why these tests are performed: HEPA filter leak test, measurement of particle counts, pressure differentials, airflow velocity and smoke pattern testing
  10. Describe the quality assurance, assignment of BUD and release testing of sterile to sterile CSPs and nonsterile to sterile CSPs
  11. Develop an Environmental Sampling Plan as well as collect and document viable air and surface samples
  12. Summarize the key elements to review during the consideration of a cleanroom renovation or construction project
  13. Discuss key issues, challenges and concerns related to selecting a cleanroom certification company as well as how to read a certification report

Target Audience:
The CriticalPoint Sterile Compounding Boot Camp™ is a two-and-a-half day onsite course designed to provide practical experience and resources that will assist participants to critically evaluate existing sterile compounding practice and make modifications necessary to ensure compliance with USP . This course would be valuable for Pharmacists and Pharmacy Technicians with sterile compounding responsibility as well as other individuals who may be involved with the sterile compounding industry or regulation. Faculty includes subject matter experts in USP process, environmental consulting, pharmacy training, microbiology, beyond-use dating and stability studies.

What’s included?

  • E-learning: 10 lessons to be completed successfully before attending the live training; 10 credits ACPE
  • 2.5 days of training, lively discussions as well as practicum experiences that simulate real-life work scenarios
  • Microsoft Word SOP Templates (from ClinicalIQ’s SOP Section 2: Facility Environmental Sampling)
  • Electronic PDF copies of all speaker presentations
  • Extensive reference list as well as references themselves in pdf format
  • Re-usable Thumb Drive with all course materials and bonus materials (upon receipt of signed End User License Agreement)

Features:
Participants will be provided a light continental breakfast each morning at the conference hotel, lunch on both full days and midmorning and afternoon refreshments. A free shuttle to the training facility is included.

ACPE-Accredited:
CriticalPoint’s Sterile Compounding Boot Camp™ is approved for 29.5 CE credit hours (10 hours E-learning home study and 19.5 hours of live training) or 2.95 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). CE hours are awarded to all participants who successfully complete all 10 eLearning lessons, attend the entire program and complete the evaluation form and are submitted directly to the CPE Monitor program.

Travel Arrangements:
Participants must make all airline, shuttle and hotel reservations. Class begins at 8am on the first day and concludes at 1:15pm on the final day.  Upon registration, an information packet is sent that details hotel recommendations and corporate rates. For more information about travel arrangements, contact CriticalPoint’s Sterile Compounding Boot Camp coordinator at (973) 256-6500 or Send Us An Email.

Cancellation Policy:

Program Cancellation
CriticalPoint 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 Sterile Compounding Boot Camp 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 CriticalPoint Sterile Compounding Boot Camp™ courses 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 Sterile Compounding Boot Camp™ course 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 9:00 am Eastern time the day before 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 Sterile Compounding Boot Camp™ course 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 CriticalPoint’s Sterile Compounding Boot Camp™ 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 Sterile Compounding Boot Camp™ course 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 CriticalPoint Customer Service at moreinfo@criticalpoint.info at least 30 days prior to program.

Registration transfers
Individuals attending the course in place of the registered individual – will be honored up to the program start date. The request will also 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 5% cancellation fee. All registration cancellations must be submitted in writing or by e-mail to CriticalPoint, LLC at the following address.

Attn: Sterile Compounding Boot Camp™ Registration Customer Service
12154 Darnestown Road, # 360
Gaithersburg, MD 20878
FAX: 866-538-4352
Email: moreinfo@criticalpoint.info

Registrants may receive 100% of the program registration fees, less the 5% cancellation fee up to 30 business days prior to program start date; 50%, less 5% 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.