Instructor :
John E Lincoln

Webinar ID:
11427

As we move further into 2025, verification and validation (V&V) of regulated software remain under intense scrutiny from the U.S. FDA and global regulatory bodies.

Ensuring your products, processes, and systems meet the latest compliance standards is not just important—it’s mission-critical.

In this 60-minute expert-led webinar, you’ll gain a comprehensive roadmap for mastering V&V practices across products, processes, and QMS software. This session distills complex regulations into actionable steps, helping you align with the most current guidelines and avoid costly compliance pitfalls.

Key Topics Covered:

• • Latest regulatory updates from the FDA and global agencies for 2025.
  • Essential frameworks, including:
    • • GAMP (Good Automated Manufacturing Practice)
      • 21 CFR Part 11 for electronic records and signatures
      • IEC 62304 for software lifecycle processes
      • ISO 14971 and ICH Q9 for risk management frameworks

• • How to plan, execute, and document effective software validations.
  • The importance of risk-based validation in meeting regulatory expectations.
  • Practical strategies to implement V&V principles within existing workflows.

Equip yourself with the latest insights and best practices to build robust validation processes that stand up to regulatory scrutiny in 2025 and beyond.

Prepare for the future—secure your compliance now!

Register Today to master V&V.

As we move further into 2025, verification and validation (V&V) of regulated software remain under intense scrutiny from the U.S. FDA and global regulatory bodies.

Ensuring your products, processes, and systems meet the latest compliance standards is not just important—it’s mission-critical.

In this 60-minute expert-led webinar, you’ll gain a comprehensive roadmap for mastering V&V practices across products, processes, and QMS software. This session distills complex regulations into actionable steps, helping you align with the most current guidelines and avoid costly compliance pitfalls.

Key Topics Covered:

• • Latest regulatory updates from the FDA and global agencies for 2025.
  • Essential frameworks, including:
    • • GAMP (Good Automated Manufacturing Practice)
      • 21 CFR Part 11 for electronic records and signatures
      • IEC 62304 for software lifecycle processes
      • ISO 14971 and ICH Q9 for risk management frameworks

• • How to plan, execute, and document effective software validations.
  • The importance of risk-based validation in meeting regulatory expectations.
  • Practical strategies to implement V&V principles within existing workflows.

Equip yourself with the latest insights and best practices to build robust validation processes that stand up to regulatory scrutiny in 2025 and beyond.

Prepare for the future—secure your compliance now!

Register Today to master V&V.

In healthcare and life sciences landscape, software plays a critical role in the development and operation of medical devices, pharmaceutical processes, and quality management systems.

As innovation accelerates—from medical imaging systems to thought-controlled devices—ensuring compliance with regulatory standards has never been more urgent.

However, with greater software utilization comes intense scrutiny from the U.S. FDA and other global regulators. Nearly all software quality issues originate during the design, testing, and validation phases.

Regulatory bodies are becoming more adept at identifying shortcomings in verification and validation (V&V) processes, making robust and compliant practices an absolute necessity.

Why This Webinar is a Must-Attend:

• • Ensure Compliance with FDA Standards:
    • • Gain insights into the FDA’s preferred documentation models for ERP systems, in-device software, process controls, and cGMP data management.

• • Avoid Costly Mistakes:
    • • Learn how to mitigate compliance risks by addressing V&V challenges in design, testing, and validation phases.

• • Adapt to Increased Regulatory Oversight:
    • • Stay ahead of auditors by aligning your practices with 21 CFR Part 11, EU Annex 11, and other key regulations.

• • Improve Product Safety and Quality:
    • • Understand how effective V&V directly impacts the safety, efficacy, and reliability of your medical products.

• • Advance Your Career:
    • • Build expertise in risk-based validation and regulatory compliance—skills that are in high demand across the industry.

This webinar is ideal for professionals in medical devices, pharmaceuticals, biologics, and dietary supplements looking to enhance their software V&V practices and keep pace with evolving compliance requirements.

Equip yourself with the tools and knowledge needed to succeed in this highly regulated, resource-constrained environment.

Enroll now to stay ahead in the race for innovation and compliance!

Join Now!

In healthcare and life sciences landscape, software plays a critical role in the development and operation of medical devices, pharmaceutical processes, and quality management systems.

As innovation accelerates—from medical imaging systems to thought-controlled devices—ensuring compliance with regulatory standards has never been more urgent.

However, with greater software utilization comes intense scrutiny from the U.S. FDA and other global regulators. Nearly all software quality issues originate during the design, testing, and validation phases.

Regulatory bodies are becoming more adept at identifying shortcomings in verification and validation (V&V) processes, making robust and compliant practices an absolute necessity.

Why This Webinar is a Must-Attend:

• • Ensure Compliance with FDA Standards:
    • • Gain insights into the FDA’s preferred documentation models for ERP systems, in-device software, process controls, and cGMP data management.

• • Avoid Costly Mistakes:
    • • Learn how to mitigate compliance risks by addressing V&V challenges in design, testing, and validation phases.

• • Adapt to Increased Regulatory Oversight:
    • • Stay ahead of auditors by aligning your practices with 21 CFR Part 11, EU Annex 11, and other key regulations.

• • Improve Product Safety and Quality:
    • • Understand how effective V&V directly impacts the safety, efficacy, and reliability of your medical products.

• • Advance Your Career:
    • • Build expertise in risk-based validation and regulatory compliance—skills that are in high demand across the industry.

This webinar is ideal for professionals in medical devices, pharmaceuticals, biologics, and dietary supplements looking to enhance their software V&V practices and keep pace with evolving compliance requirements.

Equip yourself with the tools and knowledge needed to succeed in this highly regulated, resource-constrained environment.

Enroll now to stay ahead in the race for innovation and compliance!

Join Now!

1. Introduction to Verification vs. Validation (V&V)

• • Understand the core distinctions between verification and validation.
  • Learn how the FDA interprets and audits V&V practices.
  • Identify common gaps and errors in compliance assessments.

2. Building an Effective V&V Project Plan

• • Define the essential components of a risk-based, audit-ready V&V plan.
  • Tailor your plan to meet regulatory expectations and project-specific goals.

3. FDA-Preferred V&V Documentation Framework

• • Explore the documentation “model” favored by the FDA.
  • Learn how to structure your records for regulatory durability.

4. The 11 Key FDA V&V Documentation Elements

• • Deep dive into each of the 11 critical elements required by the FDA.
  • Understand how to assemble and maintain compliant documentation.

5. Software Validation for Products, Processes, and Equipment

• • Validate software in:
    • • Medical devices and product systems
      • Manufacturing and production processes
      • Test equipment and automation tools

6. Applying Qualification Protocols (DQ, IQ, OQ, PQ)

• • Learn when and how to apply:
    • • Design Qualification (DQ)
      • Installation Qualification (IQ)
      • Operational Qualification (OQ)
      • Performance Qualification (PQ)

• • Discuss equivalent protocols and industry best practices.

7. Understanding “White Box” vs. “Black Box” Validations

• • Explore testing methodologies:
    • • White box testing for internal software structure.
      • Black box testing for functional, user-facing behavior.

8. Leveraging Global Compliance Standards

• • Incorporate leading frameworks such as:
    • IEC 62304 (Software Lifecycle)
    • GAMP 5 (Automated System Validation)
    • ISO 14971 and ICH Q9 (Risk Management)

• • Strengthen global compliance strategies and cross-border alignment.

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 Verification vs. Validation (V&V)

• • Understand the core distinctions between verification and validation.
  • Learn how the FDA interprets and audits V&V practices.
  • Identify common gaps and errors in compliance assessments.

2. Building an Effective V&V Project Plan

• • Define the essential components of a risk-based, audit-ready V&V plan.
  • Tailor your plan to meet regulatory expectations and project-specific goals.

3. FDA-Preferred V&V Documentation Framework

• • Explore the documentation “model” favored by the FDA.
  • Learn how to structure your records for regulatory durability.

4. The 11 Key FDA V&V Documentation Elements

• • Deep dive into each of the 11 critical elements required by the FDA.
  • Understand how to assemble and maintain compliant documentation.

5. Software Validation for Products, Processes, and Equipment

• • Validate software in:
    • • Medical devices and product systems
      • Manufacturing and production processes
      • Test equipment and automation tools

6. Applying Qualification Protocols (DQ, IQ, OQ, PQ)

• • Learn when and how to apply:
    • • Design Qualification (DQ)
      • Installation Qualification (IQ)
      • Operational Qualification (OQ)
      • Performance Qualification (PQ)

• • Discuss equivalent protocols and industry best practices.

7. Understanding “White Box” vs. “Black Box” Validations

• • Explore testing methodologies:
    • • White box testing for internal software structure.
      • Black box testing for functional, user-facing behavior.

8. Leveraging Global Compliance Standards

• • Incorporate leading frameworks such as:
    • IEC 62304 (Software Lifecycle)
    • GAMP 5 (Automated System Validation)
    • ISO 14971 and ICH Q9 (Risk Management)

• • Strengthen global compliance strategies and cross-border alignment.

BONUS:

1. 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.

Reap the Rewards of This Training Individually or as a Group for Collective Growth!

• • Regulatory Leaders Striving to Ensure Software Compliance and Avoid Audit Risks
  • Quality Assurance Professionals Aiming to Strengthen Risk-Based Validation Processes
  • Compliance Managers Focused on Streamlining Documentation for Regulatory Readiness
  • Department Heads Seeking to Enhance Operational Efficiency Through Effective V&V
  • Software Validation Specialists Solving Complex Challenges in Testing and Validation
  • Training Heads Designing Comprehensive Learning Paths for Technical Teams
  • HR Professionals Supporting Workforce Development in Regulatory Environments
  • Medical Device Manufacturers Addressing Software Compliance Challenges for FDA Approval
  • Pharma and Biotech Professionals Focused on Ensuring CGMP Compliance

Reap the Rewards of This Training Individually or as a Group for Collective Growth!

• • Regulatory Leaders Striving to Ensure Software Compliance and Avoid Audit Risks
  • Quality Assurance Professionals Aiming to Strengthen Risk-Based Validation Processes
  • Compliance Managers Focused on Streamlining Documentation for Regulatory Readiness
  • Department Heads Seeking to Enhance Operational Efficiency Through Effective V&V
  • Software Validation Specialists Solving Complex Challenges in Testing and Validation
  • Training Heads Designing Comprehensive Learning Paths for Technical Teams
  • HR Professionals Supporting Workforce Development in Regulatory Environments
  • Medical Device Manufacturers Addressing Software Compliance Challenges for FDA Approval
  • Pharma and Biotech Professionals Focused on Ensuring CGMP Compliance