FDA Clinical Trial System Validation Mastery: 2-Day Intensive Training on GAMP 5 & 21 CFR Part 11

Future-Proof Your Clinical Trials with Expert-Led Validation & Compliance Strategies!

Instructor :
Carolyn Troiano

Webinar ID:
12134

Date: NOV 07 (THU) - NOV 08 (FRI), 2024

Start Time: 8 AM PT- 2 PM PT

Duration: 12 Hrs.

What will you learn

    • FDA Oversight Of Computer Systems And Compliance Objectives Explained
    • Introduction To GAMP 5, CSV, And SDLC Methodologies For Validation
    • Understanding 21 CFR Part 11 And Electronic Records Compliance
    • System Evaluation, Risk Management, And Classification Based On GAMP 5
    • Building A Project Management Plan For Clinical System Validation
    • Leveraging Vendors And External Resources For Validation Success
    • Incorporating BPR And OCM Principles For Process Improvement
    • Ongoing System Validation, Change Control, And ….
    • FDA Oversight Of Computer Systems And Compliance Objectives Explained
    • Introduction To GAMP 5, CSV, And SDLC Methodologies For Validation
    • Understanding 21 CFR Part 11 And Electronic Records Compliance
    • System Evaluation, Risk Management, And Classification Based On GAMP 5
    • Building A Project Management Plan For Clinical System Validation
    • Leveraging Vendors And External Resources For Validation Success
    • Incorporating BPR And OCM Principles For Process Improvement
    • Ongoing System Validation, Change Control, And Disaster Recovery Planning
    • FDA Trends, Audit Preparation, And Future Direction For Clinical Systems

Course Description

In today’s fast-paced clinical research environment, FDA compliance is critical for the computer systems used to collect, analyze, and report clinical trial data.

These systems, regulated under Good Clinical Practices (GCPs), must undergo thorough validation to ensure they meet the FDA’s stringent standards.

This 2-Day Masterclass will guide you through the FDA’s Computer System Validation (CSV) process, ensuring your clinical trial systems are compliant and audit-ready. You’ll learn how to apply GAMP 5 system classification guidelines to categorize systems effectively and optimize validation efforts based on risk, system type, and technology.

By the end of this course, you will:

    • Master the FDA’s CSV requirements and learn how to ensure your systems meet GCP standards.
    • Understand how to balance validation costs with system risk to optimize your investment.
    • Use GAMP 5 guidelines to classify systems, helping you determine the appropriate level of validation for different technologies.
    • Learn best practices for managing and validating clinical trial systems to minimize risk and maintain compliance.

Through real-world examples and expert-led sessions, you’ll gain actionable insights to streamline your validation process and stay ahead of regulatory changes.

Enroll Now!

In today’s fast-paced clinical research environment, FDA compliance is critical for the computer systems used to collect, analyze, and report clinical trial data.

These systems, regulated under Good Clinical Practices (GCPs), must undergo thorough validation to ensure they meet the FDA’s stringent standards.

This 2-Day Masterclass will guide you through the FDA’s Computer System Validation (CSV) process, ensuring your clinical trial systems are compliant and audit-ready. You’ll learn how to apply GAMP 5 system classification guidelines to categorize systems effectively and optimize validation efforts based on risk, system type, and technology.

By the end of this course, you will:

    • Master the FDA’s CSV requirements and learn how to ensure your systems meet GCP standards.
    • Understand how to balance validation costs with system risk to optimize your investment.
    • Use GAMP 5 guidelines to classify systems, helping you determine the appropriate level of validation for different technologies.
    • Learn best practices for managing and validating clinical trial systems to minimize risk and maintain compliance.

Through real-world examples and expert-led sessions, you’ll gain actionable insights to streamline your validation process and stay ahead of regulatory changes.

Enroll Now!

Why you should attend

In today’s rapidly evolving regulatory landscape, FDA compliance for clinical trial systems is more crucial than ever.

Ensuring that your computer systems are validated and meet FDA’s stringent Good Clinical Practice (GCP) standards can make the difference between a successful trial and costly setbacks.

This 2-day Virtual Seminar is designed to equip you with the essential knowledge and practical skills to navigate the complexities of Computer System Validation (CSV) for clinical trials.

By attending this course, you will:

    • Stay ahead of FDA requirements for clinical trial systems and validation, ensuring you remain compliant with the latest regulations.
    • Master the System Development Life Cycle (SDLC) methodology, learning how to apply it effectively in your validation efforts.
    • Reduce risk and optimize validation costs by utilizing GAMP 5 system classification and risk-based approaches to validation.
    • Gain insights into best industry practices and common pitfalls to avoid during system validation.
    • Learn how to develop and implement a robust validation strategy that supports the ongoing governance, archival, and retirement of clinical trial systems.

Key Benefits of Attending:

    • Comprehensive Training: Deep-dive into the phases, documentation, and deliverables required for FDA-compliant validation, including examples of in-house and custom systems.
    • Real-World Application: Learn from case studies and practical examples to apply CSV concepts directly to your clinical systems.
    • Improve Efficiency: Discover how to integrate project management, business process re-engineering, and organizational change management principles to streamline validation.
    • Maintain Compliance: Understand how to monitor and govern a validated system throughout its lifecycle, ensuring ongoing FDA compliance.
    • Advance Your Career: Equip yourself with up-to-date knowledge and skills that will enhance your ability to manage and validate clinical trial systems—key for advancing in regulatory or quality roles.

Upon completing this course, you will:

    • Understand FDA’s CSV requirements and the validation process for clinical trial systems.
    • Apply the System Development Life Cycle (SDLC) methodology to structure your validation strategy.
    • Use GAMP 5 guidelines to classify and validate systems based on risk and technology.
    • Create and maintain FDA-compliant documentation and validation processes.
    • Monitor and govern your clinical trial systems to ensure long-term compliance.
    • Incorporate project management and change management principles to improve your validation processes.
    • Leverage external resources and vendors to apply the best practices in system validation.
    • Stay up-to-date on FDA trends and audit expectations for clinical trial systems.

By attending this course, you’ll gain the tools, confidence, and expertise needed to tackle the challenges of clinical trial system validation. Don’t miss this opportunity to strengthen your compliance strategy and advance your career!

Join Now!

In today’s rapidly evolving regulatory landscape, FDA compliance for clinical trial systems is more crucial than ever.

Ensuring that your computer systems are validated and meet FDA’s stringent Good Clinical Practice (GCP) standards can make the difference between a successful trial and costly setbacks.

This 2-day Virtual Seminar is designed to equip you with the essential knowledge and practical skills to navigate the complexities of Computer System Validation (CSV) for clinical trials.

By attending this course, you will:

    • Stay ahead of FDA requirements for clinical trial systems and validation, ensuring you remain compliant with the latest regulations.
    • Master the System Development Life Cycle (SDLC) methodology, learning how to apply it effectively in your validation efforts.
    • Reduce risk and optimize validation costs by utilizing GAMP 5 system classification and risk-based approaches to validation.
    • Gain insights into best industry practices and common pitfalls to avoid during system validation.
    • Learn how to develop and implement a robust validation strategy that supports the ongoing governance, archival, and retirement of clinical trial systems.

Key Benefits of Attending:

    • Comprehensive Training: Deep-dive into the phases, documentation, and deliverables required for FDA-compliant validation, including examples of in-house and custom systems.
    • Real-World Application: Learn from case studies and practical examples to apply CSV concepts directly to your clinical systems.
    • Improve Efficiency: Discover how to integrate project management, business process re-engineering, and organizational change management principles to streamline validation.
    • Maintain Compliance: Understand how to monitor and govern a validated system throughout its lifecycle, ensuring ongoing FDA compliance.
    • Advance Your Career: Equip yourself with up-to-date knowledge and skills that will enhance your ability to manage and validate clinical trial systems—key for advancing in regulatory or quality roles.

Upon completing this course, you will:

    • Understand FDA’s CSV requirements and the validation process for clinical trial systems.
    • Apply the System Development Life Cycle (SDLC) methodology to structure your validation strategy.
    • Use GAMP 5 guidelines to classify and validate systems based on risk and technology.
    • Create and maintain FDA-compliant documentation and validation processes.
    • Monitor and govern your clinical trial systems to ensure long-term compliance.
    • Incorporate project management and change management principles to improve your validation processes.
    • Leverage external resources and vendors to apply the best practices in system validation.
    • Stay up-to-date on FDA trends and audit expectations for clinical trial systems.

By attending this course, you’ll gain the tools, confidence, and expertise needed to tackle the challenges of clinical trial system validation. Don’t miss this opportunity to strengthen your compliance strategy and advance your career!

Join Now!

Areas Covered

DAY 01(8:00 AM – 2:00 PM PT)

  • FDA oversight of computer systems used in regulated industries
    • “GxPs” defined
    • Focus on “GCPs”
    • FDA audit and inspection objectives
    • Company compliance objectives
  • Introduction to Clinical Data Systems (CDS)
    • Defining the types of systems
    • System evaluation, scoring and selection process overview
    • Discussion of industry trends in system usage
  • Introduction to Computer System Validation (CSV)
    • FDA’s Guidance for Computerized System Validation (1983)
    • Evolution of validation
    • 21 CFR Part 11 (electronic records/electronic signatures; 1987)
    • Industries (pharmaceutical, medical device, biotechnology, tobacco, organ donation)
  • System Development Life Cycle (SDLC) framework and validation
    • SDLC phases (requirements, design, testing, implementation, acceptance, release to production, change control, retirement)
    • SDLC deliverables, timing, and documentation
    • The Requirements Traceability Matrix (RTM) – a key validation deliverable of interest to FDA
  • GAMP 5 and system classification
    • GAMP 5 system categories and criteria
    • Using GAMP 5 to develop an approach to CSV for a clinical data system
    • Evolving technology – driving a mobile application across a data lake and into the cloud
  • System risk assessment and management
    • Clinical data system inventory
    • Risk assessment, mitigation and prioritization
    • Monitoring and managing system risk throughout a clinical data system’s SDLC
  • Building a solid project management plan to corral a clinical data system validation effort
    • Validation strategy and planning
    • Clinical data system implementation and validation execution
    • Validation documentation
    • System and data “owners” and “custodians”
    • Roles and responsibilities
    • Leveraging the vendor or other external resource
  • Incorporating business process re-engineering principles into the clinical data system validation effort
    • Clinical process mapping
    • Seeking opportunities for improvement
    • Building improvement into the project plan
  • Incorporating Organizational Change Management (OCM) principles into the clinical data system validation effort
    • Assessing the organization’s “appetite” for change
    • Identifying “early adopters,” “laggards,” and “resisters”
    • Effecting long-lasting change

 

DAY 02 (8:00 AM – 2:00 PM PT)

  • Example – implementing and validating a clinical data system
    • Situation overview
    • Building a strategy
    • Managing the project using the CSV principles, SDLC methodology and good project management practices
    • SDLC phases, deliverables and templates
    • Incorporating BPR and OCM practices
    • Focus on testing as key area of FDA scrutiny
    • Wrapping up the documentation package
    • Clinical data system acceptance and release
    • Policies and procedures
    • Training – timing and best approach
    • Turnover to support
    • Ongoing validation maintenance
    • System retirement and data archival
  • Ongoing monitoring and management of a clinical data system in a validated state throughout the SDLC
    • Operations and maintenance
    • System and data backup and archival
    • Change control board and best practices (high on FDA’s list for scrutiny)
    • Periodic review and assessment for revalidation
    • Policies and procedures (IT and user)
    • Ongoing training and OCM
    • Disaster Recovery (DR) planning and execution
    • Business Continuity Planning (BCP) and execution
  • System and Data Governance Board
    • Board Charter
    • Sponsorship
    • Roles and responsibilities
    • Meetings and status reporting
  • FDA’s strategy and direction – the “swinging pendulum”
    • Recent trends in FDA findings related to clinical data systems
    • Factors influencing FDA audit and inspection
    • What does the future look like?
  • Wrap-up/ Q&A

BONUS:

    1. PDF copy of the presentation handout for your future reference.
    2. Soft copy of the certificate of completion on request.

DAY 01(8:00 AM – 2:00 PM PT)

  • FDA oversight of computer systems used in regulated industries
    • “GxPs” defined
    • Focus on “GCPs”
    • FDA audit and inspection objectives
    • Company compliance objectives
  • Introduction to Clinical Data Systems (CDS)
    • Defining the types of systems
    • System evaluation, scoring and selection process overview
    • Discussion of industry trends in system usage
  • Introduction to Computer System Validation (CSV)
    • FDA’s Guidance for Computerized System Validation (1983)
    • Evolution of validation
    • 21 CFR Part 11 (electronic records/electronic signatures; 1987)
    • Industries (pharmaceutical, medical device, biotechnology, tobacco, organ donation)
  • System Development Life Cycle (SDLC) framework and validation
    • SDLC phases (requirements, design, testing, implementation, acceptance, release to production, change control, retirement)
    • SDLC deliverables, timing, and documentation
    • The Requirements Traceability Matrix (RTM) – a key validation deliverable of interest to FDA
  • GAMP 5 and system classification
    • GAMP 5 system categories and criteria
    • Using GAMP 5 to develop an approach to CSV for a clinical data system
    • Evolving technology – driving a mobile application across a data lake and into the cloud
  • System risk assessment and management
    • Clinical data system inventory
    • Risk assessment, mitigation and prioritization
    • Monitoring and managing system risk throughout a clinical data system’s SDLC
  • Building a solid project management plan to corral a clinical data system validation effort
    • Validation strategy and planning
    • Clinical data system implementation and validation execution
    • Validation documentation
    • System and data “owners” and “custodians”
    • Roles and responsibilities
    • Leveraging the vendor or other external resource
  • Incorporating business process re-engineering principles into the clinical data system validation effort
    • Clinical process mapping
    • Seeking opportunities for improvement
    • Building improvement into the project plan
  • Incorporating Organizational Change Management (OCM) principles into the clinical data system validation effort
    • Assessing the organization’s “appetite” for change
    • Identifying “early adopters,” “laggards,” and “resisters”
    • Effecting long-lasting change

 

DAY 02 (8:00 AM – 2:00 PM PT)

  • Example – implementing and validating a clinical data system
    • Situation overview
    • Building a strategy
    • Managing the project using the CSV principles, SDLC methodology and good project management practices
    • SDLC phases, deliverables and templates
    • Incorporating BPR and OCM practices
    • Focus on testing as key area of FDA scrutiny
    • Wrapping up the documentation package
    • Clinical data system acceptance and release
    • Policies and procedures
    • Training – timing and best approach
    • Turnover to support
    • Ongoing validation maintenance
    • System retirement and data archival
  • Ongoing monitoring and management of a clinical data system in a validated state throughout the SDLC
    • Operations and maintenance
    • System and data backup and archival
    • Change control board and best practices (high on FDA’s list for scrutiny)
    • Periodic review and assessment for revalidation
    • Policies and procedures (IT and user)
    • Ongoing training and OCM
    • Disaster Recovery (DR) planning and execution
    • Business Continuity Planning (BCP) and execution
  • System and Data Governance Board
    • Board Charter
    • Sponsorship
    • Roles and responsibilities
    • Meetings and status reporting
  • FDA’s strategy and direction – the “swinging pendulum”
    • Recent trends in FDA findings related to clinical data systems
    • Factors influencing FDA audit and inspection
    • What does the future look like?
  • Wrap-up/ Q&A

BONUS:

    1. PDF copy of the presentation handout for your future reference.
    2. Soft copy of the certificate of completion on request.

Who is this course for

Everybody Benefits from Watching This. Even Better When Done as a Group!

    • Leaders Seeking to Ensure Their Teams Stay Audit-Ready and FDA Compliant
    • Department Heads Looking to Streamline Clinical Data Systems and Improve Efficiency
    • Professionals Eager to Master FDA Requirements and Enhance Career Prospects
    • Training Managers Focused on Creating Effective Learning Paths for Regulatory Compliance
    • HR Professionals Striving to Align Employee Skills with Critical Compliance Needs
    • IT Managers Aiming to Implement and Validate Systems for Long-Term Compliance
    • Quality Assurance Experts Wanting to Reduce Risk and Improve Compliance Processes
    • Project Managers Overseeing Validation Projects and Seeking Effective Tools
    • Compliance Officers Focused on Staying Ahead of FDA Trends and Audits

Everybody Benefits from Watching This. Even Better When Done as a Group!

    • Leaders Seeking to Ensure Their Teams Stay Audit-Ready and FDA Compliant
    • Department Heads Looking to Streamline Clinical Data Systems and Improve Efficiency
    • Professionals Eager to Master FDA Requirements and Enhance Career Prospects
    • Training Managers Focused on Creating Effective Learning Paths for Regulatory Compliance
    • HR Professionals Striving to Align Employee Skills with Critical Compliance Needs
    • IT Managers Aiming to Implement and Validate Systems for Long-Term Compliance
    • Quality Assurance Experts Wanting to Reduce Risk and Improve Compliance Processes
    • Project Managers Overseeing Validation Projects and Seeking Effective Tools
    • Compliance Officers Focused on Staying Ahead of FDA Trends and Audits

Instructor Profile

Carolyn (McKillop) Troiano has more than 40 years of experience in the tobacco, pharmaceutical, medical device and other FDA-regulated industries. She has worked directly, or on a consulting basis, for many of the larger pharmaceutical and tobacco companies in the US and Europe, developing and executing compliance strategies and programs. Carolyn is currently active in the Association of Information Technology Professionals (AITP), and ...

Carolyn (McKillop) Troiano has more than 40 years of experience in the tobacco, pharmaceutical, medical device and other FDA-regulated industries. She has worked directly, or on a consulting basis, for many of the larger pharmaceutical and tobacco companies in the US and Europe, developing and executing compliance strategies and programs. Carolyn is currently active in the Association of Information Technology Professionals (AITP), and Project Management Institute (PMI) chapters in the Richmond, VA area.

During her career, Carolyn worked directly, or on a consulting basis, for many of the larger pharmaceutical companies in the US and Europe. She developed validation programs and strategies back in the mid-1980s, when the first FDA guidebook was published on the subject, and collaborated with FDA and other industry representatives on 21 CFR Part 11, the FDA’s electronic record/electronic signature regulation.

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