Instructor :
Carolyn Troiano

Webinar ID:
11792

In today’s fast-evolving clinical research environment, ensuring your computer systems comply with FDA regulations is critical to your trial’s success.

The FDA governs the computer systems used to collect, analyze, transfer, and report data for clinical trials, essential for obtaining drug approval. This webinar will provide you with a comprehensive roadmap to meet the FDA’s Computer System Validation (CSV) requirements for clinical trials—without the guesswork.

FDA oversight of clinical trial systems is based on a Predicate Rule, commonly known as “Good Clinical Practices” (GCPs). If you’re responsible for ensuring your organization’s systems are compliant and audit-ready, this course is essential.

What You’ll Gain from This Course:

By attending, you’ll be able to:

• Master FDA requirements for clinical trial Computer System Validation (CSV) and ensure your systems meet current regulatory expectations.
• Apply the System Development Life Cycle (SDLC) approach to effectively validate your systems while minimizing risk.
• Leverage GAMP 5 classification and risk methodologies to categorize systems and develop the right validation strategy for each.
• Build and implement a robust validation program tailored for clinical trial systems, ensuring smooth execution from planning to system retirement.
• Manage the entire validation process, from creating FDA-compliant documentation to monitoring systems that are already in production.
• Understand roles and responsibilities in validating clinical trial systems and how to lead your team to compliance success.
• Evaluate cost vs. compliance risk effectively, ensuring you make the right decisions for your clinical trial systems.
• Utilize good project management principles, incorporating business process re-engineering and organizational change management for streamlined operations.
• Develop key policies and procedures to support the smooth functioning of clinical trial systems, even after they’re in production.
• Work effectively with vendors and other external resources to apply the best industry practices, avoiding common pitfalls.
• Stay ahead of the curve with the latest FDA trends in oversight and audits of clinical trial systems, so you’ll always be prepared.

Why This Course is Critical Now

As clinical trials become increasingly digitalized, the FDA’s focus on data integrity and computer system validation is more intense than ever. The risks of non-compliance are high—delays in trials, regulatory fines, or worse, project shutdowns.

With the FDA’s guidance on CSV becoming stricter in 2024, it’s vital to have a clear understanding of how to validate your systems efficiently and keep them in compliance throughout their lifecycle.

The cost of validation can seem daunting, but by understanding GAMP 5 guidelines and risk-based system classification, you’ll ensure that your validation efforts are proportional to the system’s risk and usage, avoiding over-validation and unnecessary costs.

This course will empower you with the knowledge, tools, and best practices to confidently manage the validation process and keep your clinical trial systems in top shape.

Join Now!

In today’s fast-evolving clinical research environment, ensuring your computer systems comply with FDA regulations is critical to your trial’s success.

The FDA governs the computer systems used to collect, analyze, transfer, and report data for clinical trials, essential for obtaining drug approval. This webinar will provide you with a comprehensive roadmap to meet the FDA’s Computer System Validation (CSV) requirements for clinical trials—without the guesswork.

FDA oversight of clinical trial systems is based on a Predicate Rule, commonly known as “Good Clinical Practices” (GCPs). If you’re responsible for ensuring your organization’s systems are compliant and audit-ready, this course is essential.

What You’ll Gain from This Course:

By attending, you’ll be able to:

• Master FDA requirements for clinical trial Computer System Validation (CSV) and ensure your systems meet current regulatory expectations.
• Apply the System Development Life Cycle (SDLC) approach to effectively validate your systems while minimizing risk.
• Leverage GAMP 5 classification and risk methodologies to categorize systems and develop the right validation strategy for each.
• Build and implement a robust validation program tailored for clinical trial systems, ensuring smooth execution from planning to system retirement.
• Manage the entire validation process, from creating FDA-compliant documentation to monitoring systems that are already in production.
• Understand roles and responsibilities in validating clinical trial systems and how to lead your team to compliance success.
• Evaluate cost vs. compliance risk effectively, ensuring you make the right decisions for your clinical trial systems.
• Utilize good project management principles, incorporating business process re-engineering and organizational change management for streamlined operations.
• Develop key policies and procedures to support the smooth functioning of clinical trial systems, even after they’re in production.
• Work effectively with vendors and other external resources to apply the best industry practices, avoiding common pitfalls.
• Stay ahead of the curve with the latest FDA trends in oversight and audits of clinical trial systems, so you’ll always be prepared.

Why This Course is Critical Now

As clinical trials become increasingly digitalized, the FDA’s focus on data integrity and computer system validation is more intense than ever. The risks of non-compliance are high—delays in trials, regulatory fines, or worse, project shutdowns.

With the FDA’s guidance on CSV becoming stricter in 2024, it’s vital to have a clear understanding of how to validate your systems efficiently and keep them in compliance throughout their lifecycle.

The cost of validation can seem daunting, but by understanding GAMP 5 guidelines and risk-based system classification, you’ll ensure that your validation efforts are proportional to the system’s risk and usage, avoiding over-validation and unnecessary costs.

This course will empower you with the knowledge, tools, and best practices to confidently manage the validation process and keep your clinical trial systems in top shape.

Join Now!

Are you ready to ensure your clinical trial systems are FDA-compliant and avoid costly missteps?

This two-day virtual seminar goes beyond the basics to equip you with the cutting-edge strategies and tools needed to confidently validate your systems and keep them audit-ready.

Here’s what you’ll gain by attending:

• Master the FDA’s expectations for computer system validation, from assessing risk to delivering FDA-compliant documentation.
• Learn how to apply the System Development Life Cycle (SDLC) methodology step-by-step, ensuring your systems meet FDA standards throughout their lifecycle.
• Explore best practices and real-world examples for validating all types of clinical trial systems—whether they’re in-house, configurable, or custom-designed.
• Gain insights into ongoing system maintenance, including governance, archival, and retirement, ensuring your systems remain compliant even after implementation.
• Discover how to integrate project management, business process re-engineering, and organizational change management principles into the validation process to streamline operations.
• Learn from real-world pitfalls others have faced and how to avoid them, keeping your projects on track and under budget.

This is not just another seminar—it’s an opportunity to future-proof your compliance strategy and take your clinical trials to the next level.

Enroll Now!

Are you ready to ensure your clinical trial systems are FDA-compliant and avoid costly missteps?

This two-day virtual seminar goes beyond the basics to equip you with the cutting-edge strategies and tools needed to confidently validate your systems and keep them audit-ready.

Here’s what you’ll gain by attending:

• Master the FDA’s expectations for computer system validation, from assessing risk to delivering FDA-compliant documentation.
• Learn how to apply the System Development Life Cycle (SDLC) methodology step-by-step, ensuring your systems meet FDA standards throughout their lifecycle.
• Explore best practices and real-world examples for validating all types of clinical trial systems—whether they’re in-house, configurable, or custom-designed.
• Gain insights into ongoing system maintenance, including governance, archival, and retirement, ensuring your systems remain compliant even after implementation.
• Discover how to integrate project management, business process re-engineering, and organizational change management principles into the validation process to streamline operations.
• Learn from real-world pitfalls others have faced and how to avoid them, keeping your projects on track and under budget.

This is not just another seminar—it’s an opportunity to future-proof your compliance strategy and take your clinical trials to the next level.

Enroll Now!

Looking for a customized version of this training tailored specifically to your team’s needs and delivered at your convenience?

• • Contact us at support@compliancemeet.com to explore your options!
  • We offer tailored sessions that focus on your specific areas of interest, available online or in-person to fit your schedule.

Day 01 (8:00 AM – 2:00 PM PT): 6 hours each day

1. FDA Oversight of Computer Systems Used in Regulated Industries
   • Understanding the role of the FDA in overseeing clinical trial systems.
2. Introduction to GxPs and Focus on GCPs
   • Defining Good Clinical Practices (GCPs) and their relevance to CSV.
3. FDA Audit and Inspection Objectives
   • Insights into FDA’s audit focus and what they look for during inspections.
4. Company Compliance Objectives
   • Aligning your organization’s objectives with FDA requirements.
5. Introduction to Clinical Data Systems (CDS)
   • Defining types of clinical data systems and understanding their role in trials.
6. System Evaluation, Scoring, and Selection Process
   • How to evaluate and select the right clinical trial systems.
7. Industry Trends in Clinical Data Systems
   • Exploring current trends and technologies in system usage.
8. Introduction to Computer System Validation (CSV)
   • Understanding the FDA’s Guidance for CSV and its evolution.
9. 21 CFR Part 11 Overview
   • Comprehending the regulation for electronic records and signatures.

11. System Development Life Cycle (SDLC) Framework
    • Key SDLC phases: requirements, design, testing, implementation, and retirement.

12. Requirements Traceability Matrix (RTM)
    • Importance of RTM as a critical validation deliverable.

13. GAMP 5 Classification and System Categories
    • Using GAMP 5 to classify systems and develop validation strategies.

14. System Risk Assessment and Management
    • Evaluating, mitigating, and managing risk throughout the SDLC

15. Building a Validation Project Management Plan
    • Creating a robust project management strategy for validation.

17. Validation Strategy and Execution
    • Steps to effectively validate clinical trial systems.

18. Roles, Responsibilities, and External Resources
    • Defining roles and leveraging vendor resources.

19. Incorporating Business Process Re-engineering (BPR) and Organizational Change Management (OCM)
    • Streamlining processes and managing organizational change.

20. Identifying Early Adopters, Laggards, and Resisters
    • Strategies to effect long-lasting organizational change.

Day 02 (8:00 AM – 2:00 PM PT): 6 hours each day

1. Example: Implementing and Validating a Clinical Data System
   • Real-world case study of building and executing a validation strategy.
2. Managing Projects Using CSV, SDLC, and Best Practices
   • Managing projects with a focus on testing and validation documentation.
3. System Acceptance and Release
   • Key steps to achieve system acceptance and successful deployment.
4. Policies, Procedures, and Training
   • Establishing necessary policies and procedures, and training strategies.
5. Ongoing Validation Maintenance and System Retirement
   • How to maintain system validation and retire systems securely.
6. Ongoing Monitoring and Change Control
   • Monitoring the system in a validated state, managing change control processes.
7. Disaster Recovery (DR) and Business Continuity Planning (BCP)
   • Strategies for disaster recovery and ensuring business continuity.
8. System and Data Governance Board
   • Defining the role of the Governance Board, including its charter and responsibilities.
9. FDA’s Strategy, Trends, and Future Outlook
   • Understanding FDA’s evolving focus on clinical data systems and preparing for future audits.

10. Wrap-Up and Q&A

• • Final thoughts and questions from participants

BONUS:

1. PDF copy of the presentation handout for your future reference.
2. Soft copy of the certificate of completion on request.
3. Q&A Session with the Presenter: Get your pressing questions answered verbally, via chat or email

Looking for a customized version of this training tailored specifically to your team’s needs and delivered at your convenience?

• • Contact us at support@compliancemeet.com to explore your options!
  • We offer tailored sessions that focus on your specific areas of interest, available online or in-person to fit your schedule.

Day 01 (8:00 AM – 2:00 PM PT): 6 hours each day

1. FDA Oversight of Computer Systems Used in Regulated Industries
   • Understanding the role of the FDA in overseeing clinical trial systems.
2. Introduction to GxPs and Focus on GCPs
   • Defining Good Clinical Practices (GCPs) and their relevance to CSV.
3. FDA Audit and Inspection Objectives
   • Insights into FDA’s audit focus and what they look for during inspections.
4. Company Compliance Objectives
   • Aligning your organization’s objectives with FDA requirements.
5. Introduction to Clinical Data Systems (CDS)
   • Defining types of clinical data systems and understanding their role in trials.
6. System Evaluation, Scoring, and Selection Process
   • How to evaluate and select the right clinical trial systems.
7. Industry Trends in Clinical Data Systems
   • Exploring current trends and technologies in system usage.
8. Introduction to Computer System Validation (CSV)
   • Understanding the FDA’s Guidance for CSV and its evolution.
9. 21 CFR Part 11 Overview
   • Comprehending the regulation for electronic records and signatures.

11. System Development Life Cycle (SDLC) Framework
    • Key SDLC phases: requirements, design, testing, implementation, and retirement.

12. Requirements Traceability Matrix (RTM)
    • Importance of RTM as a critical validation deliverable.

13. GAMP 5 Classification and System Categories
    • Using GAMP 5 to classify systems and develop validation strategies.

14. System Risk Assessment and Management
    • Evaluating, mitigating, and managing risk throughout the SDLC

15. Building a Validation Project Management Plan
    • Creating a robust project management strategy for validation.

17. Validation Strategy and Execution
    • Steps to effectively validate clinical trial systems.

18. Roles, Responsibilities, and External Resources
    • Defining roles and leveraging vendor resources.

19. Incorporating Business Process Re-engineering (BPR) and Organizational Change Management (OCM)
    • Streamlining processes and managing organizational change.

20. Identifying Early Adopters, Laggards, and Resisters
    • Strategies to effect long-lasting organizational change.

Day 02 (8:00 AM – 2:00 PM PT): 6 hours each day

1. Example: Implementing and Validating a Clinical Data System
   • Real-world case study of building and executing a validation strategy.
2. Managing Projects Using CSV, SDLC, and Best Practices
   • Managing projects with a focus on testing and validation documentation.
3. System Acceptance and Release
   • Key steps to achieve system acceptance and successful deployment.
4. Policies, Procedures, and Training
   • Establishing necessary policies and procedures, and training strategies.
5. Ongoing Validation Maintenance and System Retirement
   • How to maintain system validation and retire systems securely.
6. Ongoing Monitoring and Change Control
   • Monitoring the system in a validated state, managing change control processes.
7. Disaster Recovery (DR) and Business Continuity Planning (BCP)
   • Strategies for disaster recovery and ensuring business continuity.
8. System and Data Governance Board
   • Defining the role of the Governance Board, including its charter and responsibilities.
9. FDA’s Strategy, Trends, and Future Outlook
   • Understanding FDA’s evolving focus on clinical data systems and preparing for future audits.

10. Wrap-Up and Q&A

• • Final thoughts and questions from participants

BONUS:

1. PDF copy of the presentation handout for your future reference.
2. Soft copy of the certificate of completion on request.
3. Q&A Session with the Presenter: Get your pressing questions answered verbally, via chat or email

Maximize The Learning Experience in A Group Setting!

This seminar is designed for professionals working in FDA-regulated industries, including pharmaceuticals, medical devices, biologics, animal health, organ donation, and tobacco.

It is particularly relevant for those involved in research and development, clinical sample manufacturing, packaging, labeling, distribution, clinical testing, adverse events management, and post-marketing surveillance.

You should attend this seminar if you are responsible for planning, executing, or managing the implementation of clinical trial systems governed by FDA regulations, or if you are involved in maintaining or supporting such systems. This course will be beneficial for:

• Data “Owners”
• Data “Stewards”
• IT Analysts, Developers, and Testers
• QC/QA Managers and Analysts
• Clinical Data Managers and Scientists
• Analytical Chemists
• Compliance and Audit Managers
• Laboratory Managers
• Automation Analysts
• Computer System Validation Specialists
• GMP Training Specialists
• Business Stakeholders and Subject Matter Experts
• Business System/Application Testers

Additionally, this seminar is ideal for consultants working in the life sciences industry who are engaged in computer system implementation, validation, and compliance.

Maximize The Learning Experience in A Group Setting!

This seminar is designed for professionals working in FDA-regulated industries, including pharmaceuticals, medical devices, biologics, animal health, organ donation, and tobacco.

It is particularly relevant for those involved in research and development, clinical sample manufacturing, packaging, labeling, distribution, clinical testing, adverse events management, and post-marketing surveillance.

You should attend this seminar if you are responsible for planning, executing, or managing the implementation of clinical trial systems governed by FDA regulations, or if you are involved in maintaining or supporting such systems. This course will be beneficial for:

• Data “Owners”
• Data “Stewards”
• IT Analysts, Developers, and Testers
• QC/QA Managers and Analysts
• Clinical Data Managers and Scientists
• Analytical Chemists
• Compliance and Audit Managers
• Laboratory Managers
• Automation Analysts
• Computer System Validation Specialists
• GMP Training Specialists
• Business Stakeholders and Subject Matter Experts
• Business System/Application Testers

Additionally, this seminar is ideal for consultants working in the life sciences industry who are engaged in computer system implementation, validation, and compliance.