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CriticalPoint eLearning: Compliance to the USP Chapter Training Requirement Print E-mail

CriticalPoint is the only comprehensive online training on sterile compounding developed specifically to meet the USP <797> training standard. The modules are flexible, and allow pharmacists charged with meeting the USP <797> training requirement to mix and match training methodologies to ensure staff is trained appropriately and the material is interesting. More customers are satisfied with CriticalPoint training than any other program.  In a recent survey, 45% of CriticalPoint users rated their experience “excellent.”  No other training alternative achieved higher than a 15% “excellent” rating from its users.

Additionally, CriticalPoint training offers up to 42 Continuing Education (CE) credits, essential for Pharmacists who need to earn credits every two years, and for Certified Pharmacy Technicians, who require credits in over 40 states.

 

Our Flagship Program: The Course in Sterile Compounding

This program delivers the required training specified in USP <797>, along with testing to document learning.  This didactic curriculum covers every topic in the USP Chapter <797> in five course modules:

Basic Compounding Skills (10 hours CE)

  • Overview of quality and the responsibilities of compounding personnel
  • Cleaning and Disinfection of Pharmacy Controlled Environments
  • Purpose and Effective Use of Policies and Procedures
  • Documentation
  • Non-Hazardous Drugs - Compounding Personnel Cleansing, Garbing and Material Handling
  • Employee Aseptic Technique Training and Competency Assessm ent
  • Use of syringes, needles, vials, ampules, and filters
  • Labeling and packaging for delivery
  • Quality release and final checks of CSPs

Environmental Sampling (4 hours CE)

  • Basics of Air Sampling
  • Volumetric Air Sampling
  • Surface Sampling >
  • Glove Fingertip Sampling

Compounding Practices (8 hours CE)

  • Filtration and Sterility Testing - USP Chapter <71>
  • Moist and Dry-Heat Sterilization – USP Chapter <797>
  • Bacterial Endotoxin (Pyrogen) Testing (USP <85>) and USP Chapter <797>
  • Material Handling
  • Automated Compounding Devices (ACDs)
  • History of compounding and USP Chapter <797>
  • Batch Documentation and CSPs
  • Determining compounded sterile preparation (CSP) beyond-use dating

Engineering Controls (4 hours CE)

  • Compounding Aseptic Isolators (CAI)
  • Laminar Airflow Workbench (LAFW)
  • Secondary Engineering Controls (ISO Class 7 and 8)
  • Testing, Certification, and Calibration of Engineering Controls/Equipment

Hazardous Drugs (6 hours CE)

  • Overview of Safe Handling of Injectable Hazardous Drugs
  • Safe Handling of Injectable Hazardous Drugs – Recommendations from OSHA, NIOSH & ASHP
  • Hazardous Drugs - Health Effects and Occupational Risks
  • Safe Handling of Injectable Hazardous Drugs – Compounding Techniques
  • Primary Engineering Controls for Use with Hazardous Drugs (BSC & CACI)
  • Garbing for Hazardous Drugs

The entire program is completely up to date with the current revisions to USP <797>.  Up to 32 hours of ACPE approved CE are available, and can be site-licensed or purchased on a per-seat basis.  The five modules can be purchased separately, as a group, or in conjunction with the Virtual Compounder™.   Contact us today, and let us help you customize a training plan for your facility.


The Virtual Compounder®

CriticalPoint’s unique Virtual Compounder modules supplement key areas of your USP Chapter <797> training program.  Expert authors have identified ten compounding skills that require specific process steps to be performed properly for effectiveness:

 

  1. Personnel Garbing
  2. Cleaning Solution Preparation
  3. Cleaning your Primary Engineering Controls (Laminar Flow Workbench, Aseptic Isolator, Containment Isolator, and Biological Safety Cabinet) (4 modules)
  4. Monthly and Daily Cleaning (2 modules)
  5. Hazardous Spill Cleanup
  6. Volumetric Air Sampling

 

Each module includes one hour of ACPE-approved CE credit.

 

The Virtual Compounder engages users to direct pharmacy personnel on the screen to perform process steps, learning and building competency in a simulated environment.  This approach improves subject retention versus a single-method learning approach. See it in action. Virtual Compounder modules can be site-licensed or purchased on a per-seat basis, and is an excellent complement to The Course in Sterile Compounding.

Policies & Procedures for <797> Compliance

Our customers frequently ask for advice on policies and procedures around sterile compounding.  To meet this need, we have partnered with ClinicalIQ to capture their expertise in a set of model policies and procedures for sterile compounding activities.   These P&P model templates are updated to reflect changes in the most current revision of the Chapter, and save you time compared to researching the Chapter, identifying best practices, and writing your own from scratch.

 

Two Model Policy & Procedure packages are available:

  • Sterile Compounding: 7 topic areas, 30 customizable Policies and Procedures, and 25 customizable forms
  • Hazardous Drug Compounding: 4 customizable Policies & Procedures and 3 customizable forms

 

A full table of contents is available, and all Policies can be purchased in our online store.

 
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