Instructor :
Carolyn Troiano

Webinar ID:
13741

The FDA’s regulatory landscape is evolving, and data-driven decision-making is at its core. However, many organizations remain trapped in a compliance-first mindset, focusing on regulatory checklists instead of quality-driven best practices.

Is your organization fully leveraging automation, digital technologies, and risk-based approaches to enhance compliance efficiency?

This expert-led training unpacks the latest FDA trends in Computer System Validation (CSV) and introduces the Computer System Assurance (CSA) approach—a risk-based, patient-centric framework that aligns compliance with quality and innovation.

Key Focus Areas:

• • Understanding FDA’s Shift
    • • Explore the agency’s evolving stance on compliance versus quality and how it impacts industry practices.

• • CSV vs. CSA
    • • Compare the traditional waterfall approach with the risk-based CSA methodology and its benefits.

• • Automation & Agile in Compliance
    • • Discover why many organizations underutilize automation, digital tools, and agile methodologies—and how to change that.

• • GAMP5 Best Practices
    • • Learn how incremental, iterative, and evolutionary approaches can streamline validation efforts.

• • Strategic Implementation
    • • Identify what’s needed for a robust Quality Management System (QMS) and disciplined teams to successfully adopt these changes.

This interactive webinar will feature real-world case studies, comparative analysis of agile vs. waterfall methodologies, and practical insights into modernizing compliance strategies.

Stay ahead of regulatory expectations—gain the knowledge to transform your CSV approach today!

Enroll Now!

The FDA’s regulatory landscape is evolving, and data-driven decision-making is at its core. However, many organizations remain trapped in a compliance-first mindset, focusing on regulatory checklists instead of quality-driven best practices.

Is your organization fully leveraging automation, digital technologies, and risk-based approaches to enhance compliance efficiency?

This expert-led training unpacks the latest FDA trends in Computer System Validation (CSV) and introduces the Computer System Assurance (CSA) approach—a risk-based, patient-centric framework that aligns compliance with quality and innovation.

Key Focus Areas:

• • Understanding FDA’s Shift
    • • Explore the agency’s evolving stance on compliance versus quality and how it impacts industry practices.

• • CSV vs. CSA
    • • Compare the traditional waterfall approach with the risk-based CSA methodology and its benefits.

• • Automation & Agile in Compliance
    • • Discover why many organizations underutilize automation, digital tools, and agile methodologies—and how to change that.

• • GAMP5 Best Practices
    • • Learn how incremental, iterative, and evolutionary approaches can streamline validation efforts.

• • Strategic Implementation
    • • Identify what’s needed for a robust Quality Management System (QMS) and disciplined teams to successfully adopt these changes.

This interactive webinar will feature real-world case studies, comparative analysis of agile vs. waterfall methodologies, and practical insights into modernizing compliance strategies.

Stay ahead of regulatory expectations—gain the knowledge to transform your CSV approach today!

Enroll Now!

Regulatory expectations are evolving, and sticking to outdated compliance methods can put your organization at risk.

The FDA is intensifying its focus on data integrity, risk-based validation, and automation, yet many companies struggle to move beyond traditional, documentation-heavy approaches.

This course is designed to help you stay compliant, improve efficiency, and drive innovation in your validation practices.

Key Benefits of Attending:

• • Stay Ahead of FDA Expectations
    • • Understand the latest FDA guidance on Computer System Assurance (CSA) and how it differs from traditional Computer System Validation (CSV).

• • Enhance Compliance Through Automation
    • • Learn how modern digital tools and automated testing can streamline validation and reduce compliance burdens.

• • Implement Agile Methodologies for Validation
    • • Move beyond the rigid waterfall model to a more flexible, risk-based approach that aligns with quality and efficiency.

• • Strengthen Your Quality Management System (QMS) 
    • • Gain insights into best practices for validation, system governance, and ongoing compliance.

This interactive training will give you the strategies, tools, and confidence to adopt modern compliance approaches while meeting regulatory requirements.

Don’t just keep up—lead the way in digital compliance!

Register Today!

Regulatory expectations are evolving, and sticking to outdated compliance methods can put your organization at risk.

The FDA is intensifying its focus on data integrity, risk-based validation, and automation, yet many companies struggle to move beyond traditional, documentation-heavy approaches.

This course is designed to help you stay compliant, improve efficiency, and drive innovation in your validation practices.

Key Benefits of Attending:

• • Stay Ahead of FDA Expectations
    • • Understand the latest FDA guidance on Computer System Assurance (CSA) and how it differs from traditional Computer System Validation (CSV).

• • Enhance Compliance Through Automation
    • • Learn how modern digital tools and automated testing can streamline validation and reduce compliance burdens.

• • Implement Agile Methodologies for Validation
    • • Move beyond the rigid waterfall model to a more flexible, risk-based approach that aligns with quality and efficiency.

• • Strengthen Your Quality Management System (QMS) 
    • • Gain insights into best practices for validation, system governance, and ongoing compliance.

This interactive training will give you the strategies, tools, and confidence to adopt modern compliance approaches while meeting regulatory requirements.

Don’t just keep up—lead the way in digital compliance!

Register Today!

1. Introduction to FDA Compliance & GxP Systems

• • Understanding GxP (Good Practice) Systems and their role in compliance
  • Identifying regulated vs. non-regulated systems
  • FDA’s evolving approach to technology and software validation

2. Modernizing Computer System Validation (CSV)

• • Aligning CSV practices with the latest FDA expectations
  • Shifting from traditional compliance to quality-focused validation
  • Common pitfalls in CSV and how to avoid them

3. Agile Software Development Life Cycle (SDLC) for Validation

• • Agile vs. Waterfall: Key differences and best use cases
  • Implementing agile methodologies for efficient validation
  • Leveraging incremental, iterative, and evolutionary approaches

4. Cloud Computing & SaaS Validation

• • FDA’s perspective on cloud-based systems and SaaS solutions
  • Best practices for cloud validation and compliance
  • Managing data integrity risks in cloud environments

5. Optimizing Validation Documentation & System Maintenance

• • Efficient documentation strategies for CSV and CSA
  • Reducing compliance burdens while maintaining regulatory readiness
  • Cost-effective approaches for ongoing system maintenance

6. Ensuring Data Integrity in a Rapidly Advancing Tech Landscape

• • Understanding FDA’s stance on data integrity and governance
  • Implementing risk-based strategies to preserve data accuracy and security
  • Common data integrity challenges and how to mitigate them

7. Regulatory Influences & Best Practices for Compliance

• • Key factors shaping FDA decision-making and industry regulations
  • Industry-proven best practices for risk-based validation
  • How to develop robust policies and procedures for compliance

8. Interactive Q&A Session

• • Addressing participant questions and real-world scenarios
  • Clarifying key concepts and practical implementation 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 Compliance & GxP Systems

• • Understanding GxP (Good Practice) Systems and their role in compliance
  • Identifying regulated vs. non-regulated systems
  • FDA’s evolving approach to technology and software validation

2. Modernizing Computer System Validation (CSV)

• • Aligning CSV practices with the latest FDA expectations
  • Shifting from traditional compliance to quality-focused validation
  • Common pitfalls in CSV and how to avoid them

3. Agile Software Development Life Cycle (SDLC) for Validation

• • Agile vs. Waterfall: Key differences and best use cases
  • Implementing agile methodologies for efficient validation
  • Leveraging incremental, iterative, and evolutionary approaches

4. Cloud Computing & SaaS Validation

• • FDA’s perspective on cloud-based systems and SaaS solutions
  • Best practices for cloud validation and compliance
  • Managing data integrity risks in cloud environments

5. Optimizing Validation Documentation & System Maintenance

• • Efficient documentation strategies for CSV and CSA
  • Reducing compliance burdens while maintaining regulatory readiness
  • Cost-effective approaches for ongoing system maintenance

6. Ensuring Data Integrity in a Rapidly Advancing Tech Landscape

• • Understanding FDA’s stance on data integrity and governance
  • Implementing risk-based strategies to preserve data accuracy and security
  • Common data integrity challenges and how to mitigate them

7. Regulatory Influences & Best Practices for Compliance

• • Key factors shaping FDA decision-making and industry regulations
  • Industry-proven best practices for risk-based validation
  • How to develop robust policies and procedures for compliance

8. Interactive Q&A Session

• • Addressing participant questions and real-world scenarios
  • Clarifying key concepts and practical implementation 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!

• • Regulatory Compliance Professionals In Life Sciences Industry
  • Quality Assurance Specialists Managing Validation Processes
  • IT And Validation Engineers Handling GxP Systems
  • CSV And CSA Experts Seeking FDA Compliance Updates
  • Pharmaceutical And Biotech Professionals Overseeing System Validation
  • Medical Device Manufacturers Navigating FDA Regulatory Requirements
  • Software Developers And Testers Working On Validated Systems
  • Clinical And Laboratory Professionals Ensuring Data Integrity Compliance

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

• • Regulatory Compliance Professionals In Life Sciences Industry
  • Quality Assurance Specialists Managing Validation Processes
  • IT And Validation Engineers Handling GxP Systems
  • CSV And CSA Experts Seeking FDA Compliance Updates
  • Pharmaceutical And Biotech Professionals Overseeing System Validation
  • Medical Device Manufacturers Navigating FDA Regulatory Requirements
  • Software Developers And Testers Working On Validated Systems
  • Clinical And Laboratory Professionals Ensuring Data Integrity Compliance