Description

Expert-Led FDA Compliance Training on Master Validation Plan Essentials

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.

Learning Objectives

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.

Agenda

1: VMP, The Unwritten Requirements

• 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

2: Risk

• 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

• Used “as needed”
• IEC 62366-1, -2
• A Human Factors / Use Engineering “Process” 
• The 9 Stages
• The UE File

Q&A

Key Points

• 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.

Who Should Attend

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.