Digital Pathology: From Implementation to Regulatory Compliance

A man in a suit and tie with a plus sign on his chest.

Course Director

A dollar sign in a circle on a white background.

Course Fee

$2650.00 Regular Registration

$2450.00 Early Bird Pricing (Register 30 Days in Advance)

Course Description

This 20-hour course provides a comprehensive and practical overview of digital pathology, from the fundamentals of Whole Slide Imaging (WSI) to the implementation and use of digital pathology in research, pharmaceutical, biotechnology, CRO, and regulated environments. The course examines the complete digital pathology workflow, including slide preparation and scanning, image quality, viewing platforms, image management, IT infrastructure, connectivity, data storage, and integration into existing pathology workflows.

 

Particular emphasis will be placed on the implementation, verification and validation of digital pathology systems and their use in GLP and other regulated environments. Participants will explore practical applications including primary histopathological evaluation, pathology peer review, collaborative and remote review, image analysis and quantitative pathology. These topics reflect the applications described throughout the course materials, including scanner validation and verification toward GLP implementation and the use of digital platforms for histopathological evaluation, peer review, conferencing and object quantification. 

 

The course will also introduce the evolving role of artificial intelligence, machine learning and deep learning in digital pathology, including their use for decision support, lesion detection, grading, quantification and AI-assisted peer review. Regulatory and quality considerations will be integrated throughout the course, including verification versus validation, intended use, and the responsibilities associated with interpretation of digital images.

Why This Course Matters

Digital pathology is transforming how pathology is performed, reviewed, shared, and integrated into pharmaceutical research and development. Whole Slide Imaging (WSI) enables pathologists and scientists to move beyond conventional microscopy toward digital workflows that support primary evaluation, peer review, remote collaboration, quantitative image analysis, and increasingly, AI-assisted decision support. Your materials specifically highlight purpose-driven digital workspaces for primary evaluation, blinded and peer review, consultation, remote and hybrid working, and AI-supported quantification and grading. 

 

However, successful digital pathology implementation requires considerably more than purchasing a scanner. Organizations must consider slide and image quality, scanner performance, viewing platforms, connectivity, image management, IT infrastructure, data storage, workflow integration, and user requirements. In pharmaceutical and CRO environments, these considerations become particularly important when digital pathology is incorporated into regulated workflows, where verification, validation, quality assurance, and GLP requirements must be addressed. Your materials specifically identify scanner validation and verification toward GLP implementation as a fundamental component of a regulatory-ready pharmaceutical workflow. 

 

At the same time, image analysis, machine learning and deep learning are expanding the capabilities of digital pathology, creating opportunities for lesion detection, quantification, grading and decision support while introducing additional considerations regarding appropriate use and validation. FullCourseBook Digital Pathology copy(1).pdf Understanding both the opportunities and the limitations of these technologies is therefore essential for pathologists, scientists, quality and regulatory professionals, and organizations planning to introduce or expand digital pathology.

 

This course provides the multidisciplinary knowledge needed to make informed decisions about digital pathology—from technology and workflow design through implementation, validation, regulatory compliance and emerging AI applications.

Who Should Attend

This course is designed for professionals involved in the evaluation, implementation, use, validation, or regulatory oversight of digital pathology in pharmaceutical, biotechnology, contract research, academic, and regulatory environments. It is appropriate for both scientific users of digital pathology and professionals responsible for ensuring that digital pathology systems and workflows are scientifically robust, fit for purpose, and compliant with applicable regulatory and quality requirements.

 

Typical attendees include pathologists and toxicologic pathologists, biomedical and research scientists, study directors, laboratory managers, regulatory affairs professionals, quality assurance and GLP professionals, validation specialists, digital pathology and imaging scientists, and professionals involved in nonclinical drug development, safety assessment, pathology peer review, or the implementation of digital pathology technologies.

Register for Live Stream Request On-Site Details

Course Content and Feedback

  • Learning Objectives

    At the end of the 20-hour course attendees will:


    • • Gain a comprehensive understanding of digital pathology and Whole Slide Imaging (WSI), including the components of a digital pathology system and the transition from conventional microscopy to digital workflows.
    • • Understand the key technical and operational requirements for implementing digital pathology, including slide preparation, scanning, image quality, viewing platforms, image management, connectivity, data storage, and IT infrastructure.
    • • Understand the principles of verification, validation, and fit-for-purpose implementation of digital pathology systems, including considerations for use in GLP and other regulated environments.
    • • Learn how digital pathology can be integrated into pharmaceutical and biotechnology research, nonclinical safety assessment, CRO operations, histopathological evaluation, pathology peer review, collaborative review, and remote working.
    • • Understand the regulatory and quality considerations associated with digital pathology and WSI, including the responsibilities of the pathologist and the importance of maintaining scientifically reliable and appropriately controlled digital workflows.
    • • Explore the applications, benefits, and limitations of image analysis, artificial intelligence, machine learning, and deep-learning tools in pathology, including their potential roles in lesion detection, quantification, grading, decision support, and peer review.
    • • Develop a practical understanding of how to plan and implement a digital pathology strategy, from selection of scanners and software through workflow design, validation, quality assurance, and routine use.
    • • Recognize the opportunities and challenges associated with digital transformation in pathology and be able to assess where digital pathology can improve efficiency, collaboration, quality, and scientific decision-making within their own organization.

  • Agenda

    • Introduction to Digital Pathology and Whole Slide Imaging (WSI)
    1. Evolution from conventional microscopy to digital pathology
    2. Principles and components of Whole Slide Imaging
    3. Digital pathology terminology and concepts
    4. Advantages and limitations of digital pathology
    5. Current applications across pathology environments
    • The Digital Pathology Ecosystem: Hardware, Software and Infrastructure
    1. Whole slide scanners and imaging technologies
    2. Viewing platforms and digital workstations
    3. Image management systems and databases
    4. Connectivity and system integration
    5. Selecting technologies according to intended use
    •  From Glass Slide to Digital Image: Scanning, Image Quality and Quality Control
    1. Tissue and slide preparation considerations
    2. Slide scanning and image acquisition
    3. Factors affecting digital image quality
    4. Quality control of whole slide images
    5. Identification and management of scanning artifacts
    • Digital Pathology Workflow Design and Implementation
    1. Mapping the conventional and digital pathology workflow
    2. Defining intended use and user requirements
    3. Integration into existing laboratory processes
    4. Workflow optimization and standardization
    5. Managing the transition from glass to digital pathology
    • Digital Pathology in Pharmaceutical R&D, CROs and Nonclinical Safety Assessment
    1. Digital pathology within pharmaceutical development
    2. Applications in CRO and research environments
    3. Digital histopathological evaluation in nonclinical studies
    4. Integration within safety assessment workflows
    5. Operational benefits and implementation challenges
    • Digital Histopathology Evaluation, Peer Review and Remote Collaboration
    1. Digital primary histopathological evaluation
    2. Digital pathology peer review workflows
    3. Blinded review and grading
    4. Remote consultation and collaborative review
    5. Remote and hybrid pathology working models
    • Data Management, Storage, Security and IT Requirements
    1. Digital slide file size and storage requirements
    2. Image databases and data management
    3. Network performance and connectivity
    4. IT infrastructure for computational pathology
    5. Data access, security and long-term management
    •  Regulatory Framework and Regulatory Considerations for Digital Pathology
    1. Regulatory concepts applicable to digital pathology
    2. Intended use and regulatory context
    3. Whole Slide Imaging systems and software
    4. Software as a Medical Device (SaMD) considerations
    5. Responsibilities associated with digital image interpretation
    • Verification and Validation of Digital Pathology Systems
    1. Verification versus validation
    2. Defining intended use and acceptance criteria
    3. Scanner and system performance assessment
    4. Validation of digital pathology workflows
    5. Documentation and objective evidence
    • Digital Pathology in GLP and Quality-Assured Environments
    1. Digital pathology within the GLP framework
    2. Scanner verification and validation toward GLP implementation
    3. Quality assurance considerations
    4. Controlled digital pathology workflows
    5. Maintaining data integrity and study reliability
    • Quantitative Image Analysis and Computational Pathology
    1. Fundamentals of digital image analysis
    2. Object detection and quantification
    3. Measurement of areas and affected tissue
    4. Quantitative and semi-quantitative approaches
    5. Integration of image analysis into pathology workflows
    • Artificial Intelligence, Machine Learning and Deep Learning in Pathology
    1. Introduction to AI and machine learning in pathology
    2. Deep learning and convolutional neural networks
    3. Lesion detection and segmentation
    4. AI-assisted quantification and grading
    5. Relationship between pathologist interpretation and AI tools
    • AI-Augmented Pathology Workflows: Applications, Opportunities and Limitations
    1. AI for study triage and early decision-making
    2. AI following primary pathological evaluation
    3. AI-assisted grading and increased detection sensitivity
    4. AI applications in pathology peer review
    5. Limitations and appropriate integration of AI tools
    • Developing and Implementing a Digital Pathology Strategy
    1. Assessing organizational needs and intended use
    2. Selecting scanners, software and viewing platforms
    3. Planning implementation and validation
    4. Integrating pathology, QA, regulatory and IT requirements
    5. Building a fit-for-purpose digital pathology workflow
    • Future Directions in Digital and Computational Pathology
    1. Evolution of digital pathology technologies
    2. Increasing integration of computational pathology
    3. Development of AI-augmented workflows
    4. Changing models of collaboration and remote pathology
    5. Preparing organizations for continued digital transformation

Registrant Information:

Each person attending a course will be asked to set up an Attendee Profile Account during the registration process. Creating an Account helps you view your order history and manage your training programs. If you are registering for others, please set up an Account in the Attendee’s name. If you are registering more than one person, you’ll need to set up a separate account for each Attendee.