Making Learning a Reality^®

Virtuosi^® is the standard pharmaceutical education tool designed for the pharma industry.

Created by QxP technical experts in adult learning, content, and technology; Virtuosi delivers a learning platform that is unmatched. It fosters a paradigm shift in education enabling Pharma 4.0.

• On-Demand - Modules in Sterile Manufacturing, Microbiology, and Cell & Gene Therapy
  Education that is independent of specific facility, equipment and process‍
• Standardized Content - Provides training consistency across one site or multiple sites across the globe
  Available in 5 languages‍
• Scalable - Train an unlimited number of team members at once without SME time or access to classified facilities‍
• Self-Paced - For convenient consumption of educational content‍
• Immediate Implementation - Our off-the-shelf tool means you will see impact from the time the tool is implemented‍
• Wrap-Around Care - Engagement management supports integration into your LMS and training program

‍Rapid Onboarding | Increased Productivity | Fosters Best Practices Improved Knowledge Retention | Annex 1 Compliant

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THE CONTENT

• 56 episodes consist of compliant and interactive technical courses.
• Foundational and advanced sterile manufacturing practices covering the manufacturing and microbiology in both traditional and cell and gene spaces.
• 60-90 minutes per episode (15-20 minutes per CGT episode); segmented into 2-to 12-minute lessons, allowing the employee flexibility to learn on their schedule.
• 20 unique virtual segments immersing the employee in the manufacturing and laboratory environment where it is most appropriate.
• Over 100 hours of education delivered, including process checks and knowledge assessments.

THE PRODUCT

• The Virtuosi hardware package includes a VR-ready workstation with an HTC Vive Pro®, or Pro Eye® system. These state-of-the-art systems provide true-to-life precision tracking within the painstakingly constructed Virtuosi VR aseptic facility, and microbiology and CGT laboratories.
• Our on-demand education and technique instruction content are seamlessly integrated with the VR experiences via an embedded Learning Management System (LMS).
• The cloud-based content allows for effortless delivery of updates should regulatory requirements change over time.
• Each seat-licensed user has a unique username and login credentials for single sign-on and traceability of that employee’s progress within the educational curricula. Individualized training records are generated based upon successful completion of each Virtuosi Episode and associated VR Interactive Experience. 21 CFR 11 compliant.

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CURRICULA

MICROBIOLOGY FOR STERILE MANUFACTURING EXPERIENCE

• Industrial Microbiology
• Microbiology Laboratory Practices
  VR Serial Dilution Technique and Usage
  VR Pipette Use
• Media, Buffers, and Reagent Management
• Aseptic Technique and Behavior in Laboratories
  VR Hand Washing
  VR Vertical & Horizontal
• Unidirectional Air Flow
• Sampling and Sample Management
• Microbial Identification and Culture Maintenance
  VR Streaking for Isolation
  VR Gram Staining
• Microbial Limits Testing
  VR Microbial Limits Testing
• Sterility Testing
  VR Sterility Testing
• Microbiological Investigations
• Bacterial Endotoxin Testing
  VR BET Solution and Sample Preparation
• Preservatives and Antimicrobial Effectiveness Testing
• Sterilization Indicator Control and Usage
• Microbiology Data Evaluation and Reporting
• Microbiology Method Suitability

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STERILE MANUFACTURING EXPERIENCE

• Sterility Assurance
• Aseptic Technique and Behavior in Manufacturing
  VR Hand Washing
  VR Fallen Vial Intervention
  VR Needle Change Intervention
• Gowning for Classified Environments
• Sterilization Process Control
• Terminal Sterilization Process Control
• Sterile Filtration Process Control
• Depyrogenation Process Control
• Isolator Process Control
• The Math and Science of Sterilization and Depyrogenation
• Facility Cleaning and Disinfection
  VR Techniques of Walls and Floors
• Air Flow Pattern Studies
  VR Vertical and Horizontal Unidirectional Air Flow
• Environmental Monitoring
  VR Environmental Monitoring Sampling Plan Development
  VR Contact Plates and Swab Sampling
• Manufacturing Equipment Use Cycle
  VR Making Vertical and Horizontal Aseptic Connections
• Equipment Cleaning
• Formulation of Bulk Product
• Container Closure Integrity and Visual Inspection
  VR Visual Inspection of Vials, Ampoules, and I.V. Bags
• Aseptic Process Simulation

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CELL AND GENE | ATMP EXPERIENCE

• Introduction to ATMPs
• Life Science Fundamentals - Cells, Genes, and Proteins
• The Science Behind ATMPs
• ATMP Manufacturing Overview
• Cell Therapy Manufacturing Overview
• The Quality Management System
• Quality in Manufacturing Support Functions
• Aseptic Technique and Behavior Essentials
  VR Handwashing
• Non-Sterile Gowning
• Pipettes and Pipette Aids
• Pipette Use and Care
  VR Large Volume Pipetting
  VR Introduction to Micropipetting
  VR Pipetting Small Volumes
  VR Multichannel Pipette Techniques
• Sterile and Non-Sterile Gloving
  Demo Donning Sterile Gloves Demonstration Video
• Surface Sanitization
• Sterile Gowning
  Demo Sterile Gowning Demonstration
• Biosafety Cabinet Types and Uses
  VR Airflow in a Biosafety Cabinet
• Preparing to Use the Biosafety Cabinet
• Operating in a Biosafety Cabinet
  VR Using a Biosafety Cabinet
• Gene Therapy Manufacturing Overview
• Aseptic Technique and Behavior in a Cleanroom
  VR Vertical and Horizontal Air Flow
• Introduction to Aseptic Connections
• Connectors - Types and Uses
• Tube Welding
• Aseptic Disconnections
• Fluid Transfers
• Sampling with Aseptic Connections

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Virtuosi® is brought to you by Quality Executive Partners, Inc., (QxP), a globally recognized management consulting firm that includes leading technical experts and former quality executives within the pharmaceutical industry. Our field consulting experience has shown the critical need for innovative education. Only through real education can you experience real results. Leveraging the QxP “Teach and Do” methodology, Virtuosi is poised to radically change the pharmaceutical industry and positively impact the lives of patients.