Comprehensive Pharmaceutical Sterile Product Manufacturing and Microbiology Training Courses

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.

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Coaching and Knowledge Assessments

Data integrity in the microbiology laboratory, importance of sample integrity, equipment qualification, and growth promotion of media used for enumeration.

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Technical and Regulatory Concepts

Equipment qualification and maintenance, along with design, validation, and execution of a variety of test methods.

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Definitions

Biological Indicator (BI), Bacterial Endotoxin Testing (BET), Data Integrity (DI), Method Suitability, Genus, Sample Integrity, Species, Sterility Assurance

Course Overview

Concepts and approaches to laboratory design and layout, supplies and consumables management, microbiology equipment, aseptic techniques, and principles for microbial enumeration.

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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.

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Technical and Regulatory Concepts

Inventory management of supplies, investigation of results to identify source of contamination, laboratory maintenance, and data integrity applications.

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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

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.

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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.

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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.

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Definitions

Acceptance Criteria, Aliquot, Colony, Environmental Monitoring (EM), Fermentation, Genotype, Method Validation, Morphology, Selective Media, Subculture, Surfactant

Course Overview

Presentation of the aseptic techniques and behaviors used by laboratory personnel, including the importance of hygiene, gloving, and surface sanitization.

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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.

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Technical and Regulatory Concepts

Engineering controls, aseptic techniques and behaviors applied to both housekeeping and testing in the laboratory.

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Definitions

Cross-contamination, Biological Safety Cabinet (BSC), High-Efficiency Particulate Air (HEPA) Filter, Isolator, Laminar Air Flow, Personnel Monitoring, Sanitization

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.

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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.

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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.

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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)

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.

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Coaching and Knowledge Assessments

Confirming the ability to determine an appropriate identification technique and to apply that technique to theoretical results.

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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.

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Definitions

Agar Slant, Cryoprotectant, Genotype, Gram Stain, Isolate, Lyophilization, Morphology, Passage, Pathogenicity, Phenotype, Pure Culture, Reference Culture, Stock Culture, Suitability Study, Taxonomy, Working Culture

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.

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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.

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Technical and Regulatory Concepts

Method suitability and its importance for preparing samples, definition of appropriate media for various organisms, and interpreting final results.

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Definitions

Acceptance Criteria, Coliform, Emulsion, Filtration Manifold, Membrane Filtration, Microbial Enumeration, Pathogenic, Pour Plate Method, Spread Plate Method, Subculture

Course Overview

Purpose and application of sterility testing, the appropriate materials, methods, and equipment for execution, and how to interpret the results.

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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.

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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.

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Definitions

Aseptic Processing, Classified Area, Isolator, Method Suitability, Septicemia, Sterility Assurance, Species, Surfactant, Turbidity, Vapor Phase Hydrogen Peroxide (VPHP)

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.

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Coaching and Knowledge Assessments

Methods to affect or destroy endotoxin, strategies to determine limits, and endotoxin test method types and descriptions.

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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.

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Definitions

Chromogenic Assay, Endotoxin Units (EU), Gram-Negative, Limulus Amoebocyte Lysate (LAL), Photometric Measurement, Qualitative, Quantitative, Reference Standard Endotoxin (RSE), Turbidity

Course Overview

Overview of why certain pharmaceutical products require preservatives, how preservatives are selected, and how they are tested for antimicrobial effectiveness.

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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.

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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

Course Overview

Theory of sterilization indicator use to demonstrate sterilization process adequacy and endotoxin indicator application to depyrogenation cycles.

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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.

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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.

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Definitions

Bacterial Endotoxin Test (BET), D-Value, Genetic Sequencing, Heat Shock, Lyophilization, Maceration, Pyrogen, Resistance, Serial Dilution, Spore Form, Steam Sterilization, Vegetative Form

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.

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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.

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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.

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Definitions

Acceptance Criteria, Alert Level, Environmental Monitoring (EM), Out of Level (OOL), Out of Specification (OOS), Quantitative, Qualitative, Too Numerous to Count (TNTC), Trend

Course Overview

Overview of the concepts required to identify and investigate microbiological results that have deviated from predefined acceptance criteria or internal levels.

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Coaching and Knowledge Assessments

Differentiation between specifications, levels, and internal limits and understanding the differences between Phase I and Phase II investigations.

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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.

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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

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.

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Coaching and Knowledge Assessments

Method suitability types, considerations, phases, elements, and life cycle, and ability to evaluate proper aseptic technique.

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Technical and Regulatory Concepts

Method verification, method validation, alternative method validation, test cases to enhance understanding, and the life cycle of method suitability.

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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)

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.

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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.

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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

Course Overview

Proper aseptic technique and behaviors required throughout the manufacturing process and how they protect the product and patient from contamination.

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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.

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Definitions

Aseptic Processing, Doffing, Donning, Environmental Monitoring, Flora, Handwashing, Hygiene, Line Clearance, Pass-Through, Turbulence, Unidirectional Air Flow (UAF)

Course Overview

Approach to educating, training, and qualifying personnel for all levels of gowning that are required to support pharmaceutical manufacturing.

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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.

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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

Course Overview

Overview of the development and use of steam to sterilize equipment and components required in aseptic manufacturing and testing.

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Coaching and Knowledge Assessments

Type of steam ideal for sterilization, sterilization parameters, process parameter validation, autoclave cycle phases, and load definition guidelines.

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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.

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Definitions

Chemical Indicator (CI), Contamination, Latent Heat, Lethality, Load, Log Reduction, Saturated Steam, Steam-in-Place (SIP), Sterility Assurance Level (SAL), Wrap

Course Overview

Overview of the development and use of terminal sterilization, precautions with the process, and ensuring it remains in a state of control.

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Coaching and Knowledge Assessments

Appropriate use of terminal sterilization, packaging considerations, validating changes to the sterilization cycle, and application of parametric release.

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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.

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Definitions

Conduction Heat, Convection Heat, Contamination, Dry Heat, Ethylene Oxide, Heat Labile, F0, Latent Heat, Radiation, Sterility Assurance Level (SAL), Terminal Sterilization

Course Overview

Overview of the use of sterilizing filters to render liquids and gasses sterile, filtration operation and its associated validation lifecycle.

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Coaching and Knowledge Assessments

Filter material of construction, media, differential pressure as an indicator of a filter’s strength, and bubble point value.

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Technical and Regulatory Concepts

Materials of Construction, filtration application, process application, validation of sterilization using filtration, and integrity testing.

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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)

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.

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Coaching and Knowledge Assessments

Impact of material of construction, differences between depyrogenation processes in ovens and tunnels, and differences between sterilization and depyrogenation.

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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.

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Definitions

Bacterial Endotoxin, Convection, Depyrogenation Tunnel, Lipopolysaccharide, Log Reduction, Periodic Review, Preventive Maintenance (PM), Pyrogen, Residence Time, Thermocouple

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.

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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.

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Technical and Regulatory Concepts

Isolator operations challenges, reduction of human intervention to significantly improve sterility assurance, leak testing and glove management.

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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

Course Overview

Detailed review of the various methods of sterilization and depyrogenation as well as the importance to patients.

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Coaching and Knowledge Assessments

Material compatibility with sterilization methods and critical process parameters and their identification in the sterilization and depyrogenation processes.

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Technical and Regulatory Concepts

Science behind sterilization processes, from steam sterilization to depyrogenation, consideration of material types, and calculation of critical process parameters.

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Definitions

Biological Indicator (BI), Chemical Indicator (CI), Depyrogenation, Endotoxin, Ethylene Oxide, Spore Form, Thermal Mass, Vapor Phase Hydrogen Peroxide (VPHP), Water for Injection (WFI)

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.

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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.

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Technical and Regulatory Concepts

Standardized methodologies for the selection and qualification of a disinfecting agent, Environmental Monitoring Performance Qualification, and routine monitoring requirements.

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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

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.

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Coaching and Knowledge Assessments

Importance of removal of particulate, HVAC design principles and relevant calculations, and ISO classification system and application.

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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.

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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)

Course Overview

Application of a risk-based approach to developing a comprehensive Environmental Monitoring Program.

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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.

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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.

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Definitions

Action Level, Alert Level, Code of Federal Regulations (CFR), EudraLex, Excursion, Genus, Gram Stain, Intervention, Investigation, Risk Assessment (RA), Species, Trend

Course Overview

Detailed review of the handling of aseptic equipment, including cleaning, wrapping, sterilization or depyrogenation, staging, and aseptic installation.

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Coaching and Knowledge Assessments

Importance of proper sequencing, containment of waste, labeling of equipment, reduction of manipulations, and documentation requirements for cleaning cycles.

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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.

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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

Course Overview

Review of the importance of cleaning process equipment, the basics of cleaning process control, and an overview of the various cleaning methods.

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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.

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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.

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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)

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.

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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.

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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.

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Definitions

Aseptic Connection, Continued Process Verification (CPV), Reprocessing, Sampling Plan, Sterile Filtration, Stability Testing, Sterility Testing

Course Overview

Importance of product packaging remaining integral to protect the drug as well as the approaches to visual inspection for defects.

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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.

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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.

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Definitions

Acceptable Quality Level (AQL), Defect, Integral, International Organization of Standardization (ISO), United States Pharmacopeia (USP), World Health Organization (WHO)

Course Overview

Proper techniques and program requirements for validating an aseptic process and maintaining the validated state of that process.

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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.

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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.

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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

Course Overview

Learn and practice the steps for successful handwashing to aid in contamination control.

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Coaching and Knowledge Assessments

Goals of learning proper handwashing and how it helps to prevent the spread of contamination.

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Technical and Regulatory Concepts

Hygiene, Handwashing, Contamination Control

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Definitions

Handwashing, Contamination

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Course Overview

Concepts and approaches to laboratory design and layout, supplies and consumables management, microbiology equipment, aseptic techniques, and principles for microbial enumeration.

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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.

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Technical and Regulatory Concepts

Inventory management of supplies, investigation of results to identify source of contamination, laboratory maintenance, and data integrity applications.

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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

Course Overview

Presentation of the aseptic techniques and behaviors used by laboratory personnel, including the importance of hygiene, gloving, and surface sanitization.

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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

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.

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Definitions

Aseptic Processing, Doffing, Donning, Environmental Monitoring, Flora, Handwashing, Hygiene, Line Clearance, Pass-Through, Turbulence, Unidirectional Air Flow (UAF)

Course Overview

Learn the specific techniques and methods for using pipettes and pipettors to ensure that the correct volumes are transferred and used in the manufacture or testing process.

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Coaching and Knowledge Assessments

Includes practice activities, coaching and feedback to teach good techniques for pipetting large volumes, and allows the learner to practice these techniques in a virtual laboratory setting.

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Technical and Regulatory Concepts

Liquid Transfer, Precision and Accuracy, Laboratory Controls

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Definitions

Nominal Volume, Headspace, Viscous, Calibration, To Deliver (TD), Blow Out, To Contain (TC)

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Course Overview

Learn and practice good techniques for using micropipettes to transfer liquid.

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Coaching and Knowledge Assessments

Includes practice activities, coaching and feedback to teach good techniques for transferring liquids using micropipettes, and allows the learner to practice these techniques in a virtual laboratory setting.

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Technical and Regulatory Concepts

Liquid Transfer, Precision and Accuracy, Laboratory Controls

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Definitions

Nominal Volume, Headspace, Viscous, Calibration, To Deliver (TD), Blow Out, To Contain (TC), Forward Pipetting, Reverse Pipetting

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Course Overview

Learn and practice good techniques for pipetting small volumes.

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Coaching and Knowledge Assessments

Includes practice activities, coaching and feedback to teach good techniques for pipetting small volumes, and allows the learner to practice these techniques in a virtual laboratory setting.

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Technical and Regulatory Concepts

Liquid Transfer, Precision and Accuracy, Laboratory Controls

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Definitions

Nominal Volume, Headspace, Viscous, Calibration, To Deliver (TD), Blow Out, To Contain (TC), Forward Pipetting, Reverse Pipetting

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Course Overview

Learn and practice good techniques for pipetting using a multichannel pipette.

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Coaching and Knowledge Assessments

Includes practice activities, coaching and feedback to teach good techniques for using a multichannel pipette, and allows the learner to practice these techniques in a virtual laboratory setting.

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Technical and Regulatory Concepts

Liquid Transfer, Precision and Accuracy, Laboratory Controls

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Definitions

Nominal Volume, Headspace, Viscous, Calibration, To Deliver (TD), Blow Out, To Contain (TC), Forward Pipetting, Reverse Pipetting, Multichannel Pipette

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Course Overview

Learn about the proper aseptic technique and behaviors required throughout the manufacturing process and how they protect the product and patient from contamination.

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Coaching and Knowledge Assessments

Goals of aseptic technique and behavior and use of the science of Microbiology to identify contamination at its source.

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Technical and Regulatory Concepts

Hygiene, Handwashing, Sterile Gloving and Gowning, Surface Sanitization, Transitions of Material and People, Cleanroom Behaviors, Manual Interventions

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Definitions

Aseptic Processing, Doffing, Donning, Environmental Monitoring, Flora, Handwashing, Hygiene, Line Clearance, Pass-Through, Turbulence, Unidirectional Air Flow (UAF)

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Course Overview

Learn how personnel and materials impact vertical and horizontal airflow, explore how personnel movement affects airflow, and practice moving in a way that minimizes airflow disruption.

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Coaching and Knowledge Assessments

Goals of learning the proper techniques and behaviors when operating in a vertical or horizontal airflow environment, and the impact of incorrect actions.

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Technical and Regulatory Concepts

Airflow, Aseptic Techniques and Behaviors, Slow and Deliberate Movement

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Definitions

Aseptic Processing, Environmental Monitoring, Vertical Airflow, Horizontal Airflow

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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

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

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)

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.

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Definitions

Chromogenic Assay, Endotoxin Units (EU), Gram-Negative, Limulus Amoebocyte Lysate (LAL), Photometric Measurement, Qualitative, Quantitative, Reference Standard Endotoxin (RSE), Turbidity

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

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.

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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)

Course Overview

Application of a risk-based approach to developing a comprehensive Environmental Monitoring Program.

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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.

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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.

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Definitions

Action Level, Alert Level, Code of Federal Regulations (CFR), EudraLex, Excursion, Genus, Gram Stain, Intervention, Investigation, Risk Assessment (RA), Species, Trend

Course Overview

Detailed review of the handling of aseptic equipment, including cleaning, wrapping, sterilization or depyrogenation, staging, and aseptic installation.

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Coaching and Knowledge Assessments

Importance of proper sequencing, containment of waste, labeling of equipment, reduction of manipulations, and documentation requirements for cleaning cycles.

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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.

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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

Course Overview

Importance of product packaging remaining integral to protect the drug as well as the approaches to visual inspection for defects.

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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.

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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.

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Definitions

Acceptable Quality Level (AQL), Defect, Integral, International Organization of Standardization (ISO), United States Pharmacopeia (USP), World Health Organization (WHO)