Many organizations already have validation plans in place, yet inspections still surface findings — often from missing links between validation activities, unclear structure or incomplete documentation, weak alignment with risk-based principles, and expectations that the regulations imply but never state outright. These gaps can translate into inspection observations and project delays.

This 3-hour session walks through how to build and maintain a Master Validation Plan (MVP) aligned with FDA and EU (Annex 15) expectations. It covers the V&V foundation, how to define and trace “Requirements,” the practical use of DQ/IQ/OQ/PQ, risk management under ISO 14971 and ICH Q9, software validation documentation with Part 11 and cybersecurity, and where Human Factors / Use Engineering (IEC 62366-1/-2) applies. Attendees receive the presentation materials, and a certificate of completion is provided.

After this webinar, attendees will be able to answer -

• How does a Master Validation Plan need to be structured so that validation activities link together and hold up during an FDA inspection?
• What are the expectations that inspectors apply but that the regulations don’t spell out explicitly?
• Where is the line between Verification and Validation, and between Product, Process, Equipment, and Facility validation?
• How should DQ, IQ, OQ, and PQ be applied on a risk basis — and how do you justify the number of PQ runs without defaulting to a “rule of threes”?
• How do ISO 14971 and ICH Q9 principles factor into product risk management within the plan?
• What documentation does software validation require, and how do 21 CFR Part 11 and cybersecurity considerations fit in?

Agenda at a glance:

• Part 1 — VMP and the Unwritten Requirements (~75 min): V&V defined, VMP planning, individual validation plans and test reports, Requirements, DQ/IQ/OQ/PQ with examples, determining the number of PQs, and software V&V documentation.
• Part 2 — Risk (~40 min): ISO 14971 and ICH Q9, what risk is and isn’t, the Risk Management File, hazards list, FTA, and FMECAs.
• Part 3 — Use Engineering (~40 min): when it applies, IEC 62366-1/-2, the Human Factors process and its 9 stages, and the UE File.
• Q&A and summation (~10 min). Section timings and slide counts are approximate.

This webinar benefits the following agencies -

The session is built around FDA cGMP expectations and EU GMP Annex 15, and references ISO 14971, ICH Q9, IEC 62366-1/-2, and 21 CFR Part 11. It is relevant to organizations operating under FDA and EU regulatory frameworks for pharmaceuticals, medical devices, biologics, and dietary supplements.

Who should attend?

Professionals responsible for product, process, software, and system validation in FDA- and EU-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 others with validation responsibilities