Mastering Verification & Validation: Building a Compliant V&V Plan Aligned With FDA, ISO 13485 & ISO 14971
Ensure Regulatory Compliance With A Robust, Audit-Ready V&V Strategy!
Instructor :
John E Lincoln
Webinar ID:
13890
Date: APR 16, 2025 (WED)
Start Time: 10 AM PT - 11:30 AM PT
Duration: 90 Mins.
What you will learn
-
- Build A Risk-Based Master Validation Plan From Scratch
- Differentiate Product, Process, And Equipment Validation Requirements
- Apply DQ, IQ, OQ, PQ Protocols Effectively And Efficiently
- Integrate ISO 14971 Tools Into Validation Planning
- Align Validation Activities With FDA’s Current Regulatory Expectations
- Identify And Prepare Key Software Validation Documentation
- Incorporate 21 CFR Part 11 Into Your V&V ….
-
- Build A Risk-Based Master Validation Plan From Scratch
- Differentiate Product, Process, And Equipment Validation Requirements
- Apply DQ, IQ, OQ, PQ Protocols Effectively And Efficiently
- Integrate ISO 14971 Tools Into Validation Planning
- Align Validation Activities With FDA’s Current Regulatory Expectations
- Identify And Prepare Key Software Validation Documentation
- Incorporate 21 CFR Part 11 Into Your V&V Framework
- Avoid Common Validation Pitfalls That Trigger FDA Observations
Course Description
With increasing scrutiny from the FDA and a surge in high-profile recalls, it’s clear that many life science companies face critical gaps in their cGMP compliance—particularly around Verification and Validation (V&V) planning.
This training addresses these challenges head-on by guiding participants through the creation of a comprehensive, risk-based Master Validation Plan (MVP) aligned with FDA, ISO 13485, and ISO 14971 requirements.
Participants will explore how to structure a V&V strategy that connects directly to hazard analysis and risk management frameworks, ensuring all validation efforts are not just complete—but meaningful.
Through clear, actionable insights, this course will cover:
-
- Key components of a Master Validation Plan and how to align them with ISO 14971 principles
- The role and integration of Design Qualification (DQ), Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ)
- Efficient allocation of limited resources (personnel, time, budget) while maintaining compliance
- Use of validation matrices to streamline V&V efforts across product, process, equipment, and software
- Incorporation of QMS elements and 21 CFR Part 11 compliance in the planning process
Whether you’re building your V&V framework from scratch or optimizing an existing one, this course provides the strategic foundation needed to ensure nothing critical falls through the cracks.
Enroll Now!
With increasing scrutiny from the FDA and a surge in high-profile recalls, it’s clear that many life science companies face critical gaps in their cGMP compliance—particularly around Verification and Validation (V&V) planning.
This training addresses these challenges head-on by guiding participants through the creation of a comprehensive, risk-based Master Validation Plan (MVP) aligned with FDA, ISO 13485, and ISO 14971 requirements.
Participants will explore how to structure a V&V strategy that connects directly to hazard analysis and risk management frameworks, ensuring all validation efforts are not just complete—but meaningful.
Through clear, actionable insights, this course will cover:
-
- Key components of a Master Validation Plan and how to align them with ISO 14971 principles
- The role and integration of Design Qualification (DQ), Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ)
- Efficient allocation of limited resources (personnel, time, budget) while maintaining compliance
- Use of validation matrices to streamline V&V efforts across product, process, equipment, and software
- Incorporation of QMS elements and 21 CFR Part 11 compliance in the planning process
Whether you’re building your V&V framework from scratch or optimizing an existing one, this course provides the strategic foundation needed to ensure nothing critical falls through the cracks.
Enroll Now!
Why you should attend
Many companies spend millions on V&V activities—yet still fall short of meeting FDA and ISO expectations. Why?
Because poor upfront planning and disconnected risk strategies often result in gaps that lead to compliance failures, costly recalls, or product delays.
This course empowers you to get ahead of those risks with practical, expert-led guidance on building a unified, risk-based V&V plan from the start.
You’ll gain:
-
- A clear understanding of regulatory expectations and how to meet them efficiently
- Insights into common V&V pitfalls and how to avoid them
- Tools to align your validation efforts with ISO 14971 hazard analysis and risk management
- Strategies to maximize outcomes within limited budgets and resources
If you’re responsible for product quality, regulatory compliance, or validation planning, this training will help you deliver safer products, reduce compliance risks, and boost audit readiness.
Register Today!
Many companies spend millions on V&V activities—yet still fall short of meeting FDA and ISO expectations. Why?
Because poor upfront planning and disconnected risk strategies often result in gaps that lead to compliance failures, costly recalls, or product delays.
This course empowers you to get ahead of those risks with practical, expert-led guidance on building a unified, risk-based V&V plan from the start.
You’ll gain:
-
- A clear understanding of regulatory expectations and how to meet them efficiently
- Insights into common V&V pitfalls and how to avoid them
- Tools to align your validation efforts with ISO 14971 hazard analysis and risk management
- Strategies to maximize outcomes within limited budgets and resources
If you’re responsible for product quality, regulatory compliance, or validation planning, this training will help you deliver safer products, reduce compliance risks, and boost audit readiness.
Register Today!
Areas Covered
1. Regulatory Landscape and Expectations
-
- Understanding the difference between Verification vs. Validation
- Overview of current FDA expectations and recent industry trends
2. Master Validation Plan (MVP) Essentials
-
- Core components and structure of a compliant Master Validation Plan
- Integrating ISO 13485 and ISO 14971 into your MVP
3. Product vs. Process and Equipment Validation
-
- Key distinctions between product validation and process/equipment validation
- Real-world implications of FDA’s latest guidance on process, equipment, and facility validation
4. Effective Use of Qualification Protocols
-
- When and how to apply DQ (Design Qualification), IQ (Installation Qualification), OQ (Operational Qualification), and PQ (Performance Qualification)
- Adapting qualification protocols to resource-constrained environments
5. Risk Management Integration
-
- Leveraging ISO 14971 and ICH Q9 for product risk assessment
- Using risk tools to strengthen validation strategies
6. Software Validation Essentials
-
- The 11 critical documents needed for software validation
- Suggested test case formats for effective documentation
7. Compliance With 21 CFR Part 11
-
- Practical steps to incorporate Part 11 electronic records and signatures compliance into your V&V plan
BONUS:
-
- PDF copy of the presentation handout for your future reference.
- Soft copy of the certificate of completion on request.
- Q&A Session with the Presenter: Get your pressing questions answered verbally, via chat or email.
1. Regulatory Landscape and Expectations
-
- Understanding the difference between Verification vs. Validation
- Overview of current FDA expectations and recent industry trends
2. Master Validation Plan (MVP) Essentials
-
- Core components and structure of a compliant Master Validation Plan
- Integrating ISO 13485 and ISO 14971 into your MVP
3. Product vs. Process and Equipment Validation
-
- Key distinctions between product validation and process/equipment validation
- Real-world implications of FDA’s latest guidance on process, equipment, and facility validation
4. Effective Use of Qualification Protocols
-
- When and how to apply DQ (Design Qualification), IQ (Installation Qualification), OQ (Operational Qualification), and PQ (Performance Qualification)
- Adapting qualification protocols to resource-constrained environments
5. Risk Management Integration
-
- Leveraging ISO 14971 and ICH Q9 for product risk assessment
- Using risk tools to strengthen validation strategies
6. Software Validation Essentials
-
- The 11 critical documents needed for software validation
- Suggested test case formats for effective documentation
7. Compliance With 21 CFR Part 11
-
- Practical steps to incorporate Part 11 electronic records and signatures compliance into your V&V plan
BONUS:
-
- PDF copy of the presentation handout for your future reference.
- Soft copy of the certificate of completion on request.
- Q&A Session with the Presenter: Get your pressing questions answered verbally, via chat or email.
Who is this course for
Everybody benefits from watching this. Even better when done as a group!
-
- Quality Assurance And Quality Control Professionals
- Regulatory Affairs And Compliance Team Members
- Validation And Verification Specialists In Life Sciences
- R&D And Product Development Managers
- Manufacturing And Process Engineering Personnel
- Medical Device And Biotech Industry Professionals
- Pharmaceutical Operations And QA Leadership Teams
- Professionals Preparing For FDA Or ISO Audits
Everybody benefits from watching this. Even better when done as a group!
-
- Quality Assurance And Quality Control Professionals
- Regulatory Affairs And Compliance Team Members
- Validation And Verification Specialists In Life Sciences
- R&D And Product Development Managers
- Manufacturing And Process Engineering Personnel
- Medical Device And Biotech Industry Professionals
- Pharmaceutical Operations And QA Leadership Teams
- Professionals Preparing For FDA Or ISO Audits
Instructor Profile
John E. Lincoln is a medical device and regulatory affairs consultant. He has helped companies to implement or modify their GMP systems and procedures, product risk management, U.S. FDA responses. In addition, he has successfully designed, written and run all types of process, equipment and software qualifications/validations, which have passed FDA audit or submission scrutiny, and described in peer-reviewed technical articles, and workshops, world wide.
John has also managed pilot production, regulatory affairs, product development/design control, 510(k) submissions, risk management per ISO 14971, and projects; with over 28 years of experience in the FDA-regulated medical products industry – working with start-ups to Fortune 100 companies, including Abbott Laboratories, Hospira, Tyco/Mallinckrodt. He is a graduate of UCLA.
