Instructor :
Carolyn Troiano

Webinar ID:
13902

Over the past 30 years, the FDA’s approach to computer system validation (CSV) has shaped the compliance framework across regulated industries such as pharmaceuticals, biotechnology, and medical devices.

With the release of its Technology Modernization Action Plan (TMAP), the FDA is setting a bold new course—one that reflects the complexities of today’s digital ecosystem.

This course delves into how TMAP transforms the FDA’s collaboration with industry stakeholders, moving beyond traditional validation to encompass emerging technologies like cloud computing, Software as a Service (SaaS), and automated systems.

It highlights the growing emphasis on data integrity, not only for structured systems but also for unstructured data—including documents, spreadsheets, and multimedia files.

Through this expert-led session, participants will gain clarity on:

• • The core objectives and structure of FDA’s TMAP
  • Evolving expectations for computerized system compliance
  • The extended scope of data integrity, covering new data formats
  • How TMAP impacts risk management, validation strategies, and audit readiness
  • Key insights into aligning modern IT environments with regulatory compliance

This is an essential primer for teams looking to align their digital infrastructure with the FDA’s modernization goals—while ensuring system reliability, patient safety, and long-term compliance.

Enroll Now!

Over the past 30 years, the FDA’s approach to computer system validation (CSV) has shaped the compliance framework across regulated industries such as pharmaceuticals, biotechnology, and medical devices.

With the release of its Technology Modernization Action Plan (TMAP), the FDA is setting a bold new course—one that reflects the complexities of today’s digital ecosystem.

This course delves into how TMAP transforms the FDA’s collaboration with industry stakeholders, moving beyond traditional validation to encompass emerging technologies like cloud computing, Software as a Service (SaaS), and automated systems.

It highlights the growing emphasis on data integrity, not only for structured systems but also for unstructured data—including documents, spreadsheets, and multimedia files.

Through this expert-led session, participants will gain clarity on:

• • The core objectives and structure of FDA’s TMAP
  • Evolving expectations for computerized system compliance
  • The extended scope of data integrity, covering new data formats
  • How TMAP impacts risk management, validation strategies, and audit readiness
  • Key insights into aligning modern IT environments with regulatory compliance

This is an essential primer for teams looking to align their digital infrastructure with the FDA’s modernization goals—while ensuring system reliability, patient safety, and long-term compliance.

Enroll Now!

As the FDA accelerates its digital transformation through the Technology Modernization Action Plan (TMAP), professionals in regulated industries face increasing pressure to adapt their validation practices and safeguard data integrity—all while navigating a rapidly shifting compliance landscape.

This training goes beyond theory to deliver practical strategies you can implement immediately. You’ll gain:

• • A clear understanding of how TMAP impacts CSV requirements
  • Tools to build a risk-based validation framework aligned with System Development Life Cycle (SDLC) principles
  • Insights into maintaining systems in a continuously validated state
  • Actionable guidance on handling data integrity concerns that often trigger Form 483s and Warning Letters

Whether you’re preparing for an upcoming FDA inspection or updating your compliance strategy, this session provides real-world insights and expert-tested approaches that will keep your systems audit-ready and future-proof.

Join Now!

As the FDA accelerates its digital transformation through the Technology Modernization Action Plan (TMAP), professionals in regulated industries face increasing pressure to adapt their validation practices and safeguard data integrity—all while navigating a rapidly shifting compliance landscape.

This training goes beyond theory to deliver practical strategies you can implement immediately. You’ll gain:

• • A clear understanding of how TMAP impacts CSV requirements
  • Tools to build a risk-based validation framework aligned with System Development Life Cycle (SDLC) principles
  • Insights into maintaining systems in a continuously validated state
  • Actionable guidance on handling data integrity concerns that often trigger Form 483s and Warning Letters

Whether you’re preparing for an upcoming FDA inspection or updating your compliance strategy, this session provides real-world insights and expert-tested approaches that will keep your systems audit-ready and future-proof.

Join Now!

1. Introduction to FDA Technology Modernization

• • Overview of the FDA’s Technology Modernization Action Plan (TMAP)
  • Key initiatives underway and what’s planned for the near future
  • Implications of modernization on regulated industries

2. Understanding GxP Systems and Their Compliance Role

• • How to identify and classify GxP-relevant systems
  • Importance of GxP documentation that meets FDA standards

3. Modern Approaches to Computer System Validation (CSV)

• • Current FDA expectations for CSV
  • Applying the System Development Life Cycle (SDLC) for validation
  • Transitioning to agile validation models and automated testing for continuous validation

4. Validating Emerging Technologies

• • Effective validation strategies for cloud computing and Software as a Service (SaaS)
  • Adapting traditional validation frameworks for modern IT environments

5. Best Practices in Documentation and Lifecycle Maintenance

• • Comprehensive documentation across the system lifecycle:
    • • Requirements, design, development, testing, operations

• • Efficient and compliant approaches to maintain systems in a validated state

6. Data Integrity and Risk-Based Compliance

• • Ensuring data integrity for both structured and unstructured data types
  • Policies and procedures for ongoing compliance and risk mitigation
  • Understanding regulatory trends that influence FDA’s inspection focus

7. Implementing Industry Best Practices

• • Leveraging risk-based approaches for sustainable validation and data integrity
  • Practical insights for audit readiness and regulatory success

8. Interactive Q&A Session

• • Get expert answers to your specific compliance and validation challenges

BONUS:

1. 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.

1. Introduction to FDA Technology Modernization

• • Overview of the FDA’s Technology Modernization Action Plan (TMAP)
  • Key initiatives underway and what’s planned for the near future
  • Implications of modernization on regulated industries

2. Understanding GxP Systems and Their Compliance Role

• • How to identify and classify GxP-relevant systems
  • Importance of GxP documentation that meets FDA standards

3. Modern Approaches to Computer System Validation (CSV)

• • Current FDA expectations for CSV
  • Applying the System Development Life Cycle (SDLC) for validation
  • Transitioning to agile validation models and automated testing for continuous validation

4. Validating Emerging Technologies

• • Effective validation strategies for cloud computing and Software as a Service (SaaS)
  • Adapting traditional validation frameworks for modern IT environments

5. Best Practices in Documentation and Lifecycle Maintenance

• • Comprehensive documentation across the system lifecycle:
    • • Requirements, design, development, testing, operations

• • Efficient and compliant approaches to maintain systems in a validated state

6. Data Integrity and Risk-Based Compliance

• • Ensuring data integrity for both structured and unstructured data types
  • Policies and procedures for ongoing compliance and risk mitigation
  • Understanding regulatory trends that influence FDA’s inspection focus

7. Implementing Industry Best Practices

• • Leveraging risk-based approaches for sustainable validation and data integrity
  • Practical insights for audit readiness and regulatory success

8. Interactive Q&A Session

• • Get expert answers to your specific compliance and validation challenges

BONUS:

1. 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.

Everybody benefits from watching this. Even better when done as a group!

• • Quality Assurance And Compliance Professionals In Life Sciences
  • Regulatory Affairs Managers Handling FDA Submissions
  • IT Professionals Managing Validated GxP Systems
  • Validation Engineers Working On CSV And SDLC
  • Data Integrity And Risk Management Specialists
  • Pharmaceutical And Biotech Manufacturing Team Leaders
  • Clinical And Laboratory System Compliance Managers
  • Consultants Supporting Regulated IT Environments

Everybody benefits from watching this. Even better when done as a group!

• • Quality Assurance And Compliance Professionals In Life Sciences
  • Regulatory Affairs Managers Handling FDA Submissions
  • IT Professionals Managing Validated GxP Systems
  • Validation Engineers Working On CSV And SDLC
  • Data Integrity And Risk Management Specialists
  • Pharmaceutical And Biotech Manufacturing Team Leaders
  • Clinical And Laboratory System Compliance Managers
  • Consultants Supporting Regulated IT Environments