Master Validation Plan for FDA cGMP Compliance

Master Validation Plan Essentials Course Description

Build a complete, compliant, and inspection-ready Master Validation Plan (MVP) aligned with FDA expectations—including the critical elements that are often not explicitly documented but still expected during audits.

Why This Training Matters

Many organizations have validation plans in place—but during inspections, gaps are frequently identified due to:

• Missing links between validation activities
• Incomplete documentation or unclear structure
• Lack of alignment with risk-based validation principles
• Failure to address expectations not explicitly stated in regulations

These gaps can lead to inspection observations, delays, and compliance risks.

What You’ll Get

🔴 Live Expert-Led Training
Gain practical, real-world insights from industry experts in a live format.

💬 Interactive Q&A Sessions
Ask questions and get instant answers during the session.

📘 Course Materials Included
Access slides and resources for ongoing reference.

🎓 Professional Certificate
Receive a recognized certificate upon completion.

Register now to strengthen your validation strategy and improve compliance readiness

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.