Education That Makes a Difference
Each Virtuosi Episode relates technical content directly to patient health and safety, which is paramount to any life science employee.
On-Demand Digital Learning
Improve engagement and understanding with detailed, on-screen video and graphics, key definitions, and additional picture-in-picture video of industry experts facilitating each course.
Each of the 31 cloud-based Episodes contains 60 to 90 minutes of content and demonstrations broken down into 2- to 12-minute segments. Learn anywhere, at any time, and at your own pace.
VR Interactive Experiences
By incorporating immersive virtual reality, Virtuosi provides a unique ability to enter, explore, and learn in our state-of-the-art virtual manufacturing and laboratory facilities.
The realistic virtual learning environment enhances learning objectives while helping learners gain confidence. This eliminates the need for costly specialty training facilities and supplies, all while removing real-world risk to production equipment and facilities.
Comprehensive Learning
We thoughtfully developed each Episode with both specific learning objectives and continuity within the curricula. Virtuosi places significant on not just the "how," but the "why" behind processes and procedures to increase learner buy-in and compliance.
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Knowledge Assessments
In order to track progress and ensure knowledge transfer of industry standards, following completion of each Episode, learners must pass a randomized exam. Successful completion will be documented within the LMS for GMP records.
Process Checks
Mini check-ins make sure learners understand the material every step of the way by reiterating key points, providing coaching, and referencing specific topic areas for review.
Glossary
A comprehensive listing of more than 24,000 technical definitions within the aseptic space aids in understanding and consistency. All terms are fully translated in English, French, German, and Spanish.
Proven Successful Outcomes
The Only Complete Learning Solution
Scalable and Standardized
Across your site, or global footprint, all employees receive the same level of training delivered by recognized industry experts.
Multiple Languages
Course content is available in English, French, German, Spanish, and Swedish to meet the needs of today's global companies.
Skill Uplift
Whether it's two months or 20 years of industry experience, you'll see skill uplift at every level within your organization. Cut onboarding time in half as a compliment to on-the-job training (OJT).
Documented Success
Track the transfer of learner knowledge using checkpoints within, and at the end of, every Episode.
Reduce SME Time
By educating your employees directly, recognized industry experts help drastically reduce the amount of SME time required for training.
Dedicated Support
Partner with our team for a defined, yet flexible, path to certification for all roles within your organization.
Series 1 Episodes
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80
Hours of Education
31
Technical Courses
18
VR Interactive Experiences
Level One
Industrial Microbiology
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L101
Industrial Microbiology
Course Overview
Overview of the foundational aspects of microbiology and the skills, tools, and steps used to analyze and reduce microbiological contamination and support the life cycle of a drug.
Coaching and Knowledge Assessments
Data integrity in the microbiology laboratory, importance of sample integrity, equipment qualification, and growth promotion of media used for enumeration.
Technical and Regulatory Concepts
Equipment qualification and maintenance, along with design, validation, and execution of a variety of test methods.
Definitions
Biological Indicator (BI), Bacterial Endotoxin Testing (BET), Data Integrity (DI), Method Suitability, Genus, Sample Integrity, Species, Sterility Assurance
Microbiology Laboratory Practices
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L102
Microbiology Laboratory Practices
Course Overview
Concepts and approaches to laboratory design and layout, supplies and consumables management, microbiology equipment, aseptic techniques, and principles for microbial enumeration.
Coaching and Knowledge Assessments
Location of testing specific areas, efficiency principles applied to consumables (first expiry, first out), proper pipette use, and application to serial dilutions, including relevant calculations.
Technical and Regulatory Concepts
Inventory management of supplies, investigation of results to identify source of contamination, laboratory maintenance, and data integrity applications.
Definitions
Aseptic Technique and Behavior (ATB), Bacterial Endotoxin Testing (BET), Bioburden, Colony Forming Unit (CFU), Depyrogenation, Gram Stain, Microbial Enumeration, Sanitization, Serial Dilution, Sterilization, Viable Particulate, Turbidity
Media, Buffers, and Reagent Management
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L103
Media, Buffers, and Reagent Management
Course Overview
Explore the foundational principles of media and its importance in supporting routine testing and processing of samples — specifically buffers, reagents, and microbiological media.
Coaching and Knowledge Assessments
Various types of media and their composition, application, and suitability for different test methods, impact of pH, role of surfactants, choice of media containers, and purpose of quality control testing.
Technical and Regulatory Concepts
Commonly used materials, including preparation, sterilization, and validation of growth media with recommended steps and storage considerations; sterility and growth promotion testing.
Definitions
Acceptance Criteria, Aliquot, Colony, Environmental Monitoring (EM), Fermentation, Genotype, Method Validation, Morphology, Selective Media, Subculture, Surfactant
Aseptic Technique and Behavior in Laboratories
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L104
Aseptic Technique and Behavior in Laboratories
Course Overview
Presentation of the aseptic techniques and behaviors used by laboratory personnel, including the importance of hygiene, gloving, and surface sanitization.
Coaching and Knowledge Assessments
Understanding what aseptic technique and behaviors are and why they are important, including handwashing and hygiene, glove selection and donning techniques, sample types, and tools for sample collection.
Technical and Regulatory Concepts
Engineering controls, aseptic techniques and behaviors applied to both housekeeping and testing in the laboratory.
Definitions
Cross-contamination, Biological Safety Cabinet (BSC), High-Efficiency Particulate Air (HEPA) Filter, Isolator, Laminar Air Flow, Personnel Monitoring, Sanitization
Sampling and Sample Management
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L105
Sampling and Sample Management
Course Overview
Overview of the role of the QC unit and its responsibilities regarding the sampling process, methodologies, and handling of incoming and in-process materials as well as finished products intended for microbiological analysis.
Coaching and Knowledge Assessments
General process for any sampling event, including materials, methods and tools, required data points for a sample submission form, and importance of sample storage.
Technical and Regulatory Concepts
Life cycle of sample management and developing a sampling plan, including labeling, handling, and document control, ensuring chain of custody, and accurate disposition decisions.
Definitions
Aerobic, Anaerobic, Disposition, Chain of Custody, Parametric Release, Point of Use (PoU), Reserve Sample, Total Organic Carbon (TOC), Water for Injection (WFI), Risk Assessment (RA)
Level Two
Microbial Identification and Culture Maintenance
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L201
Microbial Identification and Culture Maintenance
Course Overview
Identification of microbes using a variety of techniques and approaches to maintain microbial cultures in the laboratory in both the short and long term.
Coaching and Knowledge Assessments
Confirming the ability to determine an appropriate identification technique and to apply that technique to theoretical results.
Technical and Regulatory Concepts
Confirming the identity of microbes spanning techniques from appearance on solid media to biochemical tests and genotypic methods along with best practices for maintaining cultures over different periods.
Definitions
Agar Slant, Cryoprotectant, Genotype, Gram Stain, Isolate, Lyophilization, Morphology, Passage, Pathogenicity, Phenotype, Pure Culture, Reference Culture, Stock Culture, Suitability Study, Taxonomy, Working Culture
Microbial Limits Testing
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L202
Microbial Limits Testing
Course Overview
Overview of ways to assess microbial quality of drug substances, raw materials, and nonsterile finished products as they pertain to the manufacturing of finished pharmaceuticals.
Coaching and Knowledge Assessments
Preparation of samples with differing attributes, quantitative versus qualitative testing, and specified microorganisms appropriate to demonstrate growth across different media types.
Technical and Regulatory Concepts
Method suitability and its importance for preparing samples, definition of appropriate media for various organisms, and interpreting final results.
Definitions
Acceptance Criteria, Coliform, Emulsion, Filtration Manifold, Membrane Filtration, Microbial Enumeration, Pathogenic, Pour Plate Method, Spread Plate Method, Subculture
Sterility Testing
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L203
Sterility Testing
Course Overview
Purpose and application of sterility testing, the appropriate materials, methods, and equipment for execution, and how to interpret the results.
Coaching and Knowledge Assessments
Statistical relationship between a sample and an entire batch, confirmation of the required materials to perform sterility testing, and approaches to investigating sterility test failures.
Technical and Regulatory Concepts
Importance of sterility testing and its limitations, with an emphasis on producing sterile drugs using strong aseptic techniques and behaviors to protect patients.
Definitions
Aseptic Processing, Classified Area, Isolator, Method Suitability, Septicemia, Sterility Assurance, Species, Surfactant, Turbidity, Vapor Phase Hydrogen Peroxide (VPHP)
Bacterial Endotoxin Testing
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L204
Bacterial Endotoxin Testing
Course Overview
Overview of bacterial endotoxin and their effect on patients, test method overview and limitations, and suitability requirements, as well as methods for removal and destruction of pyrogens.
Coaching and Knowledge Assessments
Methods to affect or destroy endotoxin, strategies to determine limits, and endotoxin test method types and descriptions.
Technical and Regulatory Concepts
Nature of endotoxin formation, controls, and ways to remove or destroy endotoxin; testing of samples to guide process development and support method validation; and ongoing process and product monitoring.
Definitions
Chromogenic Assay, Endotoxin Units (EU), Gram-Negative, Limulus Amoebocyte Lysate (LAL), Photometric Measurement, Qualitative, Quantitative, Reference Standard Endotoxin (RSE), Turbidity
Preservatives and Antimicrobial Effectiveness Testing
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L205
Preservatives and Antimicrobial Effectiveness Testing
Course Overview
Overview of why certain pharmaceutical products require preservatives, how preservatives are selected, and how they are tested for antimicrobial effectiveness.
Coaching and Knowledge Assessments
Standard antimicrobial effectiveness testing, calculation of log reduction for one bacterial organism, method suitability, and impact of preventing microbial contamination of sterile drugs.
Technical and Regulatory Concepts
Methods of preservation, antimicrobial effectiveness test method requirements, materials and media used, method suitability, calculations, and final interpretation of results.
Definitions
Aseptic Technique and Behavior (ATB), Bracketing, Homogeneity, Oxidation, Pour Plate Method, Risk Assessment (RA), Route of Administration, Serial Dilution, Shelf Life
Sterilization Indicator Control and Usage
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L206
Sterilization Indicator Control and Usage
Course Overview
Theory of sterilization indicator use to demonstrate sterilization process adequacy and endotoxin indicator application to depyrogenation cycles.
Coaching and Knowledge Assessments
Nature of biological and chemical indicators, calculation of bioburden, cycle lethality, endotoxin indicators, reduction in endotoxin units, and D-value determination methods.
Technical and Regulatory Concepts
Production, qualification, and use of various indicators to support design as well as, validation and ongoing monitoring of sterilization or depyrogenation processes.
Definitions
Bacterial Endotoxin Test (BET), D-Value, Genetic Sequencing, Heat Shock, Lyophilization, Maceration, Pyrogen, Resistance, Serial Dilution, Spore Form, Steam Sterilization, Vegetative Form
Level Three
Microbiology Data Evaluation and Reporting
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L301
Microbiology Data Evaluation and Reporting
Course Overview
Review of important concepts for how data from the microbiology laboratory is generated, analyzed, trended, and evaluated and how good documentation practices protect data integrity.
Coaching and Knowledge Assessments
USP and EP monographs and specifications, application of serial dilutions, and calculation of log reduction as part of Antimicrobial Effectiveness Testing.
Technical and Regulatory Concepts
Concept of data and its importance spanning test methods, procedures, and data analysis to inform decisions about facilities, product, and data integrity practices.
Definitions
Acceptance Criteria, Alert Level, Environmental Monitoring (EM), Out of Level (OOL), Out of Specification (OOS), Quantitative, Qualitative, Too Numerous to Count (TNTC), Trend
Microbiological Investigations
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L302
Microbiological Investigations
Course Overview
Overview of the concepts required to identify and investigate microbiological results that have deviated from predefined acceptance criteria or internal levels.
Coaching and Knowledge Assessments
Differentiation between specifications, levels, and internal limits and understanding the differences between Phase I and Phase II investigations.
Technical and Regulatory Concepts
Elements of an effective Microbiology Investigation Program, test cases on applying guidance on criteria that are reviewed to support batch disposition, and follow-up actions.
Definitions
Alert Level, Assignable Cause, Corrective and Preventative Action (CAPA) Effectiveness, Failure Mode, Growth Promotion, Interventions, Microbial Enumeration, Negative Control, Positive Control, Specification, Sterility Testing, Trend
Microbiology Method Suitability
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L303
Microbiology Method Suitability
Course Overview
Approach to choosing a microbiological test method for products, raw materials, and components, and how to evaluate the method’s suitability for use.
Coaching and Knowledge Assessments
Method suitability types, considerations, phases, elements, and life cycle, and ability to evaluate proper aseptic technique.
Technical and Regulatory Concepts
Method verification, method validation, alternative method validation, test cases to enhance understanding, and the life cycle of method suitability.
Definitions
Acceptance Criteria, Data Integrity (DI), Disinfectant Efficacy, Growth Curve, Growth Promotion, Life Cycle, Objectionable Organisms, Standard Curve, Supplier Qualification Program, Unidirectional Air Flow (UAF)
Level Three
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Level One
Sterility Assurance
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M101
Sterility Assurance
Course Overview
The concepts of sterility assurance spanning facilities, utilities, operators, equipment, and processes, which all work together to support the manufacture of a sterile drug product.
Coaching and Knowledge Assessments
Sterility testing, minimum sterility assurance level, depyrogenation of rubber stoppers, environmental and personnel monitoring, and aseptict technique and behavior.
Technical and Regulatory Concepts
The importance of individual processes that work together to manufacture sterile products in a reliable and reproducible manner.
Definitions
Aseptic Technique and Behavior (ATB), Bioburden, Critical Process Parameter (CPP), Critical Zone, Dosage Forms, Intervention, Risk Assessment (RA), Routes of Administration, Sanitization, Sterility Testing, Sterilization
Aseptic Technique and Behavior in Manufacturing
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M102
Aseptic Technique and Behavior in Manufacturing
Course Overview
Proper aseptic technique and behaviors required throughout the manufacturing process and how they protect the product and patient from contamination.
Coaching and Knowledge Assessments
Goals of aseptic technique and behavior and use of the science of Microbiology to identify contamination at its source.
Technical and Regulatory Concepts
Hygiene, hand washing, sterile gloving and gowning, surface sanitization, transitions of material and people, cleanroom behaviors, and manual interventions.
Definitions
Aseptic Processing, Doffing, Donning, Environmental Monitoring, Flora, Handwashing, Hygiene, Line Clearance, Pass-Through, Turbulence, Unidirectional Air Flow (UAF)
Gowning for Classified Environments
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M103
Gowning for Classified Environments
Course Overview
Approach to educating, training, and qualifying personnel for all levels of gowning that are required to support pharmaceutical manufacturing.
Coaching and Knowledge Assessments
Gowning principles, best practices for training, personnel monitoring sample locations, definition of critical junctions, and importance of hand sanitization.
Technical and Regulatory Concepts
Proper sequence of gowning, appropriate materials, and qualification and consistent personnel monitoring as part of Sterility Assurance Program.
Definitions
Aseptic Technique and Behavior (ATB), Classified Area, Gowning Qualification, ISO 5, ISO 7, ISO 8, Restricted Access Barrier System (RABS), Risk Assessment (RA), Sanitization, Sterilization
Level Two
Sterilization Process Control
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M201
Sterilization Process Control
Course Overview
Overview of the development and use of steam to sterilize equipment and components required in aseptic manufacturing and testing.
Coaching and Knowledge Assessments
Type of steam ideal for sterilization, sterilization parameters, process parameter validation, autoclave cycle phases, and load definition guidelines.
Technical and Regulatory Concepts
Sterilization as an integral part of sterility assurance, from basics of the sterilization cycle and its development to the requirements for validation, autoclave operation, SIP operation, alarms, and documentation.
Definitions
Chemical Indicator (CI), Contamination, Latent Heat, Lethality, Load, Log Reduction, Saturated Steam, Steam-in-Place (SIP), Sterility Assurance Level (SAL), Wrap
Terminal Sterilization Process Control
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M202
Terminal Sterilization Process Control
Course Overview
Overview of the development and use of terminal sterilization, precautions with the process, and ensuring it remains in a state of control.
Coaching and Knowledge Assessments
Appropriate use of terminal sterilization, packaging considerations, validating changes to the sterilization cycle, and application of parametric release.
Technical and Regulatory Concepts
Terminal sterilization method's ability to assure product is free from microbial contamination as well as concepts and the correct application of terminal sterilization from an operational perspective.
Definitions
Conduction Heat, Convection Heat, Contamination, Dry Heat, Ethylene Oxide, Heat Labile, F0, Latent Heat, Radiation, Sterility Assurance Level (SAL), Terminal Sterilization
Sterile Filtration Process Control
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M203
Sterile Filtration Process Control
Course Overview
Overview of the use of sterilizing filters to render liquids and gasses sterile, filtration operation and its associated validation lifecycle.
Coaching and Knowledge Assessments
Filter material of construction, media, differential pressure as an indicator of a filter’s strength, and bubble point value.
Technical and Regulatory Concepts
Materials of Construction, filtration application, process application, validation of sterilization using filtration, and integrity testing.
Definitions
Active Pharmaceutical Ingredient (API), Aseptic Processing, Colony-Forming Unit (CFU), Hold-Up Volume, Filter Integrity Test (FIT), Nanofiltration, Pore Size Rating, Sterility Assurance Level (SAL)
Depyrogenation Process Control
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M204
Depyrogenation Process Control
Course Overview
Overview of depyrogenation and its criticality to controlling pyrogens, as well as the proper methods to develop, validate, and control depyrogenation cycles for equipment such as tunnels and ovens.
Coaching and Knowledge Assessments
Impact of material of construction, differences between depyrogenation processes in ovens and tunnels, and differences between sterilization and depyrogenation.
Technical and Regulatory Concepts
Why depyrogenation is critical, how it is achieved, a focus on cycle development and oversight, equipment types, responding to cycle alarms, documentation, and operational maintenance.
Definitions
Bacterial Endotoxin, Convection, Depyrogenation Tunnel, Lipopolysaccharide, Log Reduction, Periodic Review, Preventive Maintenance (PM), Pyrogen, Residence Time, Thermocouple
Isolator Process Control
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M205
Isolator Process Control
Course Overview
Use of an isolator in the manufacturing of finished pharmaceuticals, approach to developing and validating the isolator decontamination cycle, and application to laboratories is also described.
Coaching and Knowledge Assessments
Largest contributing factor for microbial contamination in a cleanroom; decontamination, qualification, and validation; and, configuration of items in the isolator during decontamination.
Technical and Regulatory Concepts
Isolator operations challenges, reduction of human intervention to significantly improve sterility assurance, leak testing and glove management.
Definitions
Air Flow Pattern Studies, Biological Indicators (BI), Chemical Indicators (CI), Critical Process Parameter (CPP), Depyrogenation Oven, Material of Construction (MoC), Sterility Assurance, Terminal Sterilization
The Math and Science of Sterilization and Depyrogenation
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M206
The Math and Science of Sterilization and Depyrogenation
Course Overview
Detailed review of the various methods of sterilization and depyrogenation as well as the importance to patients.
Coaching and Knowledge Assessments
Material compatibility with sterilization methods and critical process parameters and their identification in the sterilization and depyrogenation processes.
Technical and Regulatory Concepts
Science behind sterilization processes, from steam sterilization to depyrogenation, consideration of material types, and calculation of critical process parameters.
Definitions
Biological Indicator (BI), Chemical Indicator (CI), Depyrogenation, Endotoxin, Ethylene Oxide, Spore Form, Thermal Mass, Vapor Phase Hydrogen Peroxide (VPHP), Water for Injection (WFI)
Level Three
Facility Cleaning and Disinfection
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M301
Facility Cleaning and Disinfection
Course Overview
Principles behind selecting and applying various disinfectants as well as materials and methods to verify the effectiveness of a disinfection program, thus maintaining the classified environment in a state of control.
Coaching and Knowledge Assessments
Differentiating between cleaning, sanitization, disinfection, and appropriate use of a sporicide, considerations when selecting antimicrobial agents, and use of scientific studies to confirm effectiveness.
Technical and Regulatory Concepts
Standardized methodologies for the selection and qualification of a disinfecting agent, Environmental Monitoring Performance Qualification, and routine monitoring requirements.
Definitions
Antimicrobial Agent, Clean In Place (CIP), Clean out of Place (COP), Disinfectant Efficacy, Environmental Monitoring (EM), Pathogen, Room Cleaning Plan, Sporicide, Sterility Assurance Program, Surfactant
Air Flow Pattern Studies
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M302
Air Flow Pattern Studies
Course Overview
Engineering principles and methods to create air suitable for use in a cleanroom environment, how this air is used to protect the product, and test methods for day-to-day activities.
Coaching and Knowledge Assessments
Importance of removal of particulate, HVAC design principles and relevant calculations, and ISO classification system and application.
Technical and Regulatory Concepts
Engineering principles applied to air flow design, first air principles, operator influence on air flow, proper intervention techniques, air flow pattern studies to support equipment placement, and application to laboratory hoods.
Definitions
Air Flow Pattern Studies, Aseptic Process Simulation (APS), High-Efficiency Particulate Air (HEPA) Filter, Restricted Access Barrier System (RABS), Turbulence, Unidirectional Air Flow (UAF)
Environmental Monitoring
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M303
Environmental Monitoring
Course Overview
Application of a risk-based approach to developing a comprehensive Environmental Monitoring Program.
Coaching and Knowledge Assessments
Overall understanding of the purpose and elements of the EM program, risk-based program elements, site selection and test methods, and required elements of an EMPQ.
Technical and Regulatory Concepts
Detailed focus on necessary risk assessments, contamination control principles, facility layout, process flows, air treatment requirements, materials of construction, and access controls.
Definitions
Action Level, Alert Level, Code of Federal Regulations (CFR), EudraLex, Excursion, Genus, Gram Stain, Intervention, Investigation, Risk Assessment (RA), Species, Trend
Level Four
Manufacturing Equipment Use Cycle
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M401
Manufacturing Equipment Use Cycle
Course Overview
Detailed review of the handling of aseptic equipment, including cleaning, wrapping, sterilization or depyrogenation, staging, and aseptic installation.
Coaching and Knowledge Assessments
Importance of proper sequencing, containment of waste, labeling of equipment, reduction of manipulations, and documentation requirements for cleaning cycles.
Technical and Regulatory Concepts
Cycle of processing and using equipment: cleaning, wrapping, sterilization, transportation, staging, aseptic installation, disassembly, and either discard or return for cleaning.
Definitions
Aseptic Connection, Aseptic Processing, Aseptic Technique and Behavior (ATB), Clean Hold Time (CHT), Contamination, Critical Zone, Depyrogenation, First Air, ISO 5, ISO 7, ISO 8, Risk Assessment (RA), Supplier Quality Program, Sterilization, Wrap
Equipment Cleaning
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M402
Equipment Cleaning
Course Overview
Review of the importance of cleaning process equipment, the basics of cleaning process control, and an overview of the various cleaning methods.
Coaching and Knowledge Assessments
Possible contaminants targeted by equipment cleaning, general steps of a cleaning process, considerations applied to CIP and COP, and preparation of cleaning validation protocols.
Technical and Regulatory Concepts
Removal of product, cleaning agent, residual water, and microbiological contaminants as well as best practices for cycle development, load configuration, and analytical methods.
Definitions
Bioburden, Clean In Place (CIP), Clean Out of Place (COP), Commissioning, Critical Process Parameter (CPP), Endotoxin, Residue, Risk Assessment (RA), Total Organic Carbon (TOC)
Formulation of Bulk Product
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M403
Formulation of Bulk Product
Course Overview
Review of the configuration and vessels used in formulation, as well as the validation and execution of the formulation process required for aseptic manufacturing.
Coaching and Knowledge Assessments
Equipment types and applications, principles applied to order of ingredient addition, purpose of vessel transfer, grouping of equipment to support validation matrices, and product hold times.
Technical and Regulatory Concepts
Formulation design, components, supporting equipment, and utilities to manufacture a product that contains the required sterility as well as concentrations of each ingredient to protect patients.
Definitions
Aseptic Connection, Continued Process Verification (CPV), Reprocessing, Sampling Plan, Sterile Filtration, Stability Testing, Sterility Testing
Container Closure Integrity and Visual Inspection
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M404
Container Closure Integrity and Visual Inspection
Course Overview
Importance of product packaging remaining integral to protect the drug as well as the approaches to visual inspection for defects.
Coaching and Knowledge Assessments
Purpose of container closure, definition of a fully integral container, integrity test method validation requirements, extrinsic particle risks, and best practices for manual visual inspection.
Technical and Regulatory Concepts
Container closure integrity and packaging requirements as well as visual inspection methods to assure potential defects are identified and culled out to minimize impact on patient safety.
Definitions
Acceptable Quality Level (AQL), Defect, Integral, International Organization of Standardization (ISO), United States Pharmacopeia (USP), World Health Organization (WHO)
Aseptic Process Simulation
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M405
Aseptic Process Simulation
Course Overview
Proper techniques and program requirements for validating an aseptic process and maintaining the validated state of that process.
Coaching and Knowledge Assessments
Sterility assurance level, key elements of aseptic processing, and requirements of process simulations as they relate to change control throughout the facility and product life cycle.
Technical and Regulatory Concepts
Robust process to ensure product sterility, aseptic process simulation to demonstrating the ability to consistently produce sterile material, and limitations of the sterility test method.
Definitions
Aseptic Technique and Behavior (ATB), Critical Quality Attribute (CQA), Data Integrity (DI), Gowning, Overkill, Probability of Non-Sterile Unit (PNSU), Risk Assessment (RA), Sterility Assurance
Level One
Microbiology Laboratory Practices
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L102
Microbiology Laboratory Practices
Course Overview
Concepts and approaches to laboratory design and layout, supplies and consumables management, microbiology equipment, aseptic techniques, and principles for microbial enumeration.
Coaching and Knowledge Assessments
Location of testing specific areas, efficiency principles applied to consumables (first expiry, first out), proper pipette use, and application to serial dilutions, including relevant calculations.
Technical and Regulatory Concepts
Inventory management of supplies, investigation of results to identify source of contamination, laboratory maintenance, and data integrity applications.
Definitions
Aseptic Technique and Behavior (ATB), Bacterial Endotoxin Testing (BET), Bioburden, Colony Forming Unit (CFU), Depyrogenation, Gram Stain, Microbial Enumeration, Sanitization, Serial Dilution, Sterilization, Viable Particulate, Turbidity
Aseptic Technique and Behavior in Laboratories
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L104
Aseptic Technique and Behavior in Laboratories
Course Overview
Presentation of the aseptic techniques and behaviors used by laboratory personnel, including the importance of hygiene, gloving, and surface sanitization.
Coaching and Knowledge Assessments
Understanding what aseptic technique and behaviors are and why they are important, including handwashing and hygiene, glove selection and donning techniques, sample types, and tools for sample collection.
Technical and Regulatory Concepts
Engineering controls, aseptic techniques and behaviors applied to both housekeeping and testing in the laboratory.
Definitions
Cross-contamination, Biological Safety Cabinet (BSC), High-Efficiency Particulate Air (HEPA) Filter, Isolator, Laminar Air Flow, Personnel Monitoring, Sanitization
Aseptic Technique and Behavior in Manufacturing
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M102
Aseptic Technique and Behavior in Manufacturing
Course Overview
Proper aseptic technique and behaviors required throughout the manufacturing process and how they protect the product and patient from contamination.
Coaching and Knowledge Assessments
Goals of aseptic technique and behavior and use of the science of Microbiology to identify contamination at its source.
Technical and Regulatory Concepts
Hygiene, hand washing, sterile gloving and gowning, surface sanitization, transitions of material and people, cleanroom behaviors, and manual interventions.
Definitions
Aseptic Processing, Doffing, Donning, Environmental Monitoring, Flora, Handwashing, Hygiene, Line Clearance, Pass-Through, Turbulence, Unidirectional Air Flow (UAF)
Level Two
Microbial Identification and Culture Maintenance
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L201
Microbial Identification and Culture Maintenance
Course Overview
Identification of microbes using a variety of techniques and approaches to maintain microbial cultures in the laboratory in both the short and long term.
Coaching and Knowledge Assessments
Confirming the ability to determine an appropriate identification technique and to apply that technique to theoretical results.
Technical and Regulatory Concepts
Confirming the identity of microbes spanning techniques from appearance on solid media to biochemical tests and genotypic methods along with best practices for maintaining cultures over different periods.
Definitions
Agar Slant, Cryoprotectant, Genotype, Gram Stain, Isolate, Lyophilization, Morphology, Passage, Pathogenicity, Phenotype, Pure Culture, Reference Culture, Stock Culture, Suitability Study, Taxonomy, Working Culture
Microbial Limits Testing
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L202
Microbial Limits Testing
Course Overview
Overview of ways to assess microbial quality of drug substances, raw materials, and nonsterile finished products as they pertain to the manufacturing of finished pharmaceuticals.
Coaching and Knowledge Assessments
Preparation of samples with differing attributes, quantitative versus qualitative testing, and specified microorganisms appropriate to demonstrate growth across different media types.
Technical and Regulatory Concepts
Method suitability and its importance for preparing samples, definition of appropriate media for various organisms, and interpreting final results.
Definitions
Acceptance Criteria, Coliform, Emulsion, Filtration Manifold, Membrane Filtration, Microbial Enumeration, Pathogenic, Pour Plate Method, Spread Plate Method, Subculture
Sterility Testing
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L203
Sterility Testing
Course Overview
Purpose and application of sterility testing, the appropriate materials, methods, and equipment for execution, and how to interpret the results.
Coaching and Knowledge Assessments
Statistical relationship between a sample and an entire batch, confirmation of the required materials to perform sterility testing, and approaches to investigating sterility test failures.
Technical and Regulatory Concepts
Importance of sterility testing and its limitations, with an emphasis on producing sterile drugs using strong aseptic techniques and behaviors to protect patients.
Definitions
Aseptic Processing, Classified Area, Isolator, Method Suitability, Septicemia, Sterility Assurance, Species, Surfactant, Turbidity, Vapor Phase Hydrogen Peroxide (VPHP)
Bacterial Endotoxin Testing
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L204
Bacterial Endotoxin Testing
Course Overview
Overview of bacterial endotoxin and their effect on patients, test method overview and limitations, and suitability requirements, as well as methods for removal and destruction of pyrogens.
Coaching and Knowledge Assessments
Methods to affect or destroy endotoxin, strategies to determine limits, and endotoxin test method types and descriptions.
Technical and Regulatory Concepts
Nature of endotoxin formation, controls, and ways to remove or destroy endotoxin; testing of samples to guide process development and support method validation; and ongoing process and product monitoring.
Definitions
Chromogenic Assay, Endotoxin Units (EU), Gram-Negative, Limulus Amoebocyte Lysate (LAL), Photometric Measurement, Qualitative, Quantitative, Reference Standard Endotoxin (RSE), Turbidity
Level Three
Facility Cleaning and Disinfection
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M301
Facility Cleaning and Disinfection
Course Overview
Principles behind selecting and applying various disinfectants as well as materials and methods to verify the effectiveness of a disinfection program, thus maintaining the classified environment in a state of control.
Coaching and Knowledge Assessments
Differentiating between cleaning, sanitization, disinfection, and appropriate use of a sporicide, considerations when selecting antimicrobial agents, and use of scientific studies to confirm effectiveness.
Technical and Regulatory Concepts
Standardized methodologies for the selection and qualification of a disinfecting agent, Environmental Monitoring Performance Qualification, and routine monitoring requirements.
Definitions
Antimicrobial Agent, Clean In Place (CIP), Clean out of Place (COP), Disinfectant Efficacy, Environmental Monitoring (EM), Pathogen, Room Cleaning Plan, Sporicide, Sterility Assurance Program, Surfactant
Air Flow Pattern Studies
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M302
Air Flow Pattern Studies
Course Overview
Engineering principles and methods to create air suitable for use in a cleanroom environment, how this air is used to protect the product, and test methods for day-to-day activities.
Coaching and Knowledge Assessments
Importance of removal of particulate, HVAC design principles and relevant calculations, and ISO classification system and application.
Technical and Regulatory Concepts
Engineering principles applied to air flow design, first air principles, operator influence on air flow, proper intervention techniques, air flow pattern studies to support equipment placement, and application to laboratory hoods.
Definitions
Air Flow Pattern Studies, Aseptic Process Simulation (APS), High-Efficiency Particulate Air (HEPA) Filter, Restricted Access Barrier System (RABS), Turbulence, Unidirectional Air Flow (UAF)
Environmental Monitoring
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M303
Environmental Monitoring
Course Overview
Application of a risk-based approach to developing a comprehensive Environmental Monitoring Program.
Coaching and Knowledge Assessments
Overall understanding of the purpose and elements of the EM program, risk-based program elements, site selection and test methods, and required elements of an EMPQ.
Technical and Regulatory Concepts
Detailed focus on necessary risk assessments, contamination control principles, facility layout, process flows, air treatment requirements, materials of construction, and access controls.
Definitions
Action Level, Alert Level, Code of Federal Regulations (CFR), EudraLex, Excursion, Genus, Gram Stain, Intervention, Investigation, Risk Assessment (RA), Species, Trend
Level Four
Manufacturing Equipment Use Cycle
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M401
Manufacturing Equipment Use Cycle
Course Overview
Detailed review of the handling of aseptic equipment, including cleaning, wrapping, sterilization or depyrogenation, staging, and aseptic installation.
Coaching and Knowledge Assessments
Importance of proper sequencing, containment of waste, labeling of equipment, reduction of manipulations, and documentation requirements for cleaning cycles.
Technical and Regulatory Concepts
Cycle of processing and using equipment: cleaning, wrapping, sterilization, transportation, staging, aseptic installation, disassembly, and either discard or return for cleaning.
Definitions
Aseptic Connection, Aseptic Processing, Aseptic Technique and Behavior (ATB), Clean Hold Time (CHT), Contamination, Critical Zone, Depyrogenation, First Air, ISO 5, ISO 7, ISO 8, Risk Assessment (RA), Supplier Quality Program, Sterilization, Wrap
Container Closure Integrity and Visual Inspection
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M404
Container Closure Integrity and Visual Inspection
Course Overview
Importance of product packaging remaining integral to protect the drug as well as the approaches to visual inspection for defects.
Coaching and Knowledge Assessments
Purpose of container closure, definition of a fully integral container, integrity test method validation requirements, extrinsic particle risks, and best practices for manual visual inspection.
Technical and Regulatory Concepts
Container closure integrity and packaging requirements as well as visual inspection methods to assure potential defects are identified and culled out to minimize impact on patient safety.
Definitions
Acceptable Quality Level (AQL), Defect, Integral, International Organization of Standardization (ISO), United States Pharmacopeia (USP), World Health Organization (WHO)
