Expert-Led FDA Compliance Training on Master Validation Plan Essentials
Course Overview
Recent FDA Warning Letters and high-profile product recalls have revealed significant cGMP deficiencies across the life science industry. One of the most common gaps is the absence of a robust, risk-based company-wide Validation and Verification (V&V) strategy.
This course provides a detailed, practical approach to developing an effective Master Validation Plan (MVP) that aligns with FDA and EU (Annex 15) expectations. You will learn how to evaluate your plan against ISO 14971 risk management principles to ensure all validation activities are risk-based, traceable, and audit-ready.
Key topics include:
- How to design and structure a Master Validation Plan that meets FDA, EMA, and ISO standards.
- Using Design Qualification (DQ), Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) — or their ASTM E2500 equivalents — efficiently, even with limited resources (time, budget, personnel).
- Building a practical V&V matrix that connects product, process, equipment, and software validation, ensuring no regulatory requirement is overlooked.
- Understanding the FDA definition of “risk-based validation” and how to document it effectively in your V&V test reports.
- Integrating QMS, cGMP, and 21 CFR Part 11 requirements to support a compliant, inspection-ready validation system.
- Identifying the supporting systems and documentation necessary for sustainable validation compliance.
This training equips professionals with the knowledge and tools to design validation programs that are scientifically sound, risk-based, and compliant with global regulatory expectations.
Webinar Takeaways: What You’ll Learn
By attending this Master Validation Plan – The Unwritten Requirements webinar, participants will gain practical, regulatory-driven insights into how to build and maintain a compliant validation system aligned with FDA and EU (Annex 15) expectations.
You will learn how to:
- Understand the difference between Verification and Validation (V&V) and align with current FDA and EU regulatory expectations.
- Develop and structure a comprehensive Master Validation Plan (MVP) that meets GMP and QMS standards.
- Differentiate Product Validation from Process, Equipment, and Facility Validation activities.
- Apply recent FDA guidance to ensure effective process and equipment qualification.
- Define and document “Requirements” — the foundation of V&V and validation traceability.
- Use DQ, IQ, OQ, PQ (or their equivalents) effectively for risk-based validation.
- Incorporate ISO 14971 and ICH Q9 principles for product risk management.
- Understand the 10 key documents for software validation and integrate cybersecurity considerations.
- Implement 21 CFR Part 11 requirements for electronic records and electronic signatures.
- Utilize test case templates and documentation formats that meet global compliance expectations.
Training Agenda
Intro 5 mins
1: VMP, The Unwritten Requirements ~75 mins 70 slides
- Verification and Validation – defined
- VMP Planning and the VMP
- Individual Validation Plan / Test Report
- Requirements
- DQ, IQ, OQ, PQs: Test Cases, Examples
- Determine the number of PQs – no “rule of threes”
- Software V&V documentation
Break/Q&A 10 mins
2: Risk ~40 mins 46 slides
- Mandatory ISO 14971 and ICH Q9
- What Risk Is, and Isn’t
- The Risk Management File
- Narrative; Hazards List, FTA, D-, P-, and U-FMECAs
3: Use Engineering ~40 mins 40 slides
- Used “as needed”
- IEC 62366-1, -2
- A Human Factors / Use Engineering “Process”
- The 9 Stages
- The UE File
Q&A ~10 mins(and Summation)
End
Note: Slide numbers per section are approximate.
Who Will Benefit
This course is designed for professionals responsible for product, process, software, and system validation in regulated industries, including:
- Senior Management – in pharmaceuticals, medical devices, biologics, and dietary supplements
- Quality Assurance (QA)
- Regulatory Affairs (RA)
- Research & Development (R&D)
- Engineering
- Production and Operations
- Consultants and other professionals tasked with validation responsibilities
Participants will gain practical insights to develop a comprehensive Master Validation Plan that addresses both documented and unwritten regulatory expectations, ensuring audit readiness and compliance.
This live training seminar includes the following for each registered attendee:
- A copy of the presentation slides by download
- A certificate of participation for attendee training records
- 3 Hrs Live Online Instructor Led Training
-
Q/A Session
Hear from Our Learners: Real Success Stories
⭐️⭐️⭐️⭐️⭐️
This course completely changed how we approach validation planning. It revealed the unwritten expectations auditors look for and gave practical strategies to create a robust, audit-ready Master Validation Plan."
– Senior Validation Engineer, Pharmaceutical Company
⭐️⭐️⭐️⭐️⭐️
The course gave me a clear roadmap for creating a Master Validation Plan that satisfies both documented and unwritten regulatory expectations. Highly practical and immediately applicable."
– QA Manager, Biotech
✅ Frequently Asked Questions (FAQ)
1. Who should attend?
Professionals responsible for product, process, software, and system validation, including QA/QC, regulatory affairs, R&D, engineering, production, and senior management.
2. What will I learn?
How to create a Master Validation Plan that addresses both documented and unwritten regulatory expectations and ensures audit readiness.
3. Is prior experience required?
No, though familiarity with validation principles and quality systems is helpful.
Faculty John E Lincoln
Principal, J E Lincoln and Associates
John E. Lincoln is a leading FDA compliance and regulatory affairs consultant with over 41 years of experience in FDA-regulated industries and 27 years as Principal of J. E. Lincoln and Associates LLC. He is recognized globally for his expertise in cGMP compliance, quality assurance, and medical device validation.
Throughout his career, John has partnered with pharmaceutical, biotechnology, and medical device companies — from startups to Fortune 100 organizations — across the U.S., Canada, Mexico, Europe (France, Germany, Sweden), and Asia (China, Taiwan).
His consulting specialties include:
- FDA Quality System Regulation (QSR) compliance and QMS remediation
- Process, product, and software validation (including 21 CFR Part 11 systems)
- ISO 13485 and ISO 14971 risk management implementation
- Design Control, Design History File (DHF), and Technical File development
- Regulatory submissions, including FDA 510(k) filings and responses to FDA audit observations
John has held leadership roles in Manufacturing Engineering, Quality Assurance, Quality Engineering, Regulatory Affairs, and R&D, progressing to Director and Vice President levels.
As a recognized FDA industry expert and speaker, he has:
- Authored peer-reviewed journal articles and five chapters in the RAPS textbook on validation
- Delivered global workshops, seminars, and webinars on FDA cGMP, validation, and risk management
- Helped hundreds of organizations achieve FDA and ISO compliance through practical, hands-on training
