Validation Strategy Development Workshop

Our Validation Strategy Development Workshop is designed to help engineering, quality, and regulatory teams establish a clear, compliant, and efficient roadmap for validation across the product or process lifecycle. Whether launching a new system, equipment, or process—or remediating legacy validation gaps—this workshop guides teams through the structured approach required to determine what to validate, how to validate it, and how to ensure traceable alignment with your Quality Management System (QMS) and regulatory expectations (FDA 21 CFR 820, ISO 13485, and EU MDR).

Participants gain hands-on experience defining scope, determining validation types, and mapping validation deliverables that ensure full lifecycle traceability and defendability during audits or inspections.

Customizable Options

Each workshop is tailored to your organization’s current maturity and validation needs. Choose from three delivery formats:

Training Session (Foundational)

Learn the principles of validation lifecycle management and how IQ, OQ, PQ, and SAT fit within it.

Understand requirements for documentation hierarchy, data integrity, and regulatory expectations.

Ideal for teams new to validation or expanding into regulated markets.

Sample Walkthrough (Applied Learning)

Review a sample validation project or mock scenario using templates and examples.

Practice determining validation scope and deliverables.

Ideal for cross-functional teams refining their internal processes before applying them to real equipment or systems.

Real Guided Walkthrough (Company-Specific Implementation)

Collaboratively build your validation strategy using your actual equipment, system, or process.

Facilitated by our validation consultant to identify required deliverables, clarify testing boundaries, and ensure traceability.

Teams leave with a draft or fully defined Validation Master Plan (VMP), gap assessment, and actionable roadmap

Session Length Options

While we are flexible and can customize your session lengths, here are the most popular formats, catered to your team’s needs and depth of exploration:

Format	Duration	Ideal For	Focus
Two-Day Intensive	16 hours	Cross-functional teams building or remediating a full validation program	End-to-end validation planning, documentation draft, and integration with QMS
Full-Day Workshop	8 hours	Teams developing or revising validation strategy for specific systems	Application-based discussion and documentation planning
Half-Day Workshop	4 hours	Teams needing alignment on core validation principles	Validation types, documentation flow, and traceability structure

Key Workshop Components

Each session is modular and can be adapted to your organization’s needs and systems.

1. Validation Fundamentals

Overview of validation lifecycle (concept → retirement)
Distinguishing between Verification and Validation
Understanding Regulatory Drivers: ISO 13485, 21 CFR 820, EU MDR Annex I, GAMP 5
Identifying when validation is required (equipment, software, process, utilities, cleaning, analytical, etc.)

2. Determining the Right Validation Type

Participants will learn how to determine whether a system requires:

Installation Qualification (IQ) – confirming installation meets design and specification requirements
Operational Qualification (OQ) – verifying the system operates as intended within defined limits
Performance Qualification (PQ) – demonstrating consistent performance in real-world conditions
Site Acceptance Testing (SAT) and/or Factory Acceptance Testing (FAT) – determining whether pre- and post-installation testing is applicable or sufficient

Teams evaluate which stages (IQ, OQ, PQ, SAT, FAT, or combinations) are needed based on:

Risk level and intended use
Complexity and novelty of equipment
Supplier validation evidence
Change control triggers and requalification criteria

3. Validation Planning & Documentation Hierarchy

Developing a Validation Master Plan (VMP) to define validation strategy and governance
Building or updating Standard Operating Procedures (SOPs) to align with current best practices
Creating or revising Work Instructions (WKI) for execution consistency
Establishing a Validation Traceability Matrix (VTM) linking requirements to testing
Defining Engineering Studies (e.g., tolerance studies, temperature mapping, software challenge tests) to support validation rationale

4. Process Mapping & Risk Integration

Conducting process mapping to identify validation touchpoints and dependencies
Integrating FMEA or risk-based thinking to prioritize validation scope
Mapping user requirements to design and functional specifications

5. Execution & Maintenance Strategy

Determining when and how to leverage vendor documentation (FAT, SAT, IQ protocols)
Establishing change control and revalidation triggers
Implementing lifecycle management: requalification frequency, deviation handling, and periodic review
Defining objective evidence collection methods for audit readiness

6. Deliverables and Takeaways

By the end of the workshop, your team will have:

A Validation Scope & Strategy Summary tailored to your system(s)
A draft or refined Validation Master Plan (VMP) outline
A deliverables checklist for IQ, OQ, PQ, SAT/FAT, and supporting documentation
Template examples for protocols, reports, and trace matrices
An implementation roadmap for SOP/WKI updates and process improvements

What Will Participants Learn?

Participants will learn how to:

Identify and justify which validation stages (IQ, OQ, PQ, SAT, FAT) are required and why
Develop a compliant validation documentation structure linked to QMS and risk management files
Plan and coordinate validation activities across engineering, QA, and manufacturing
Integrate vendor, design, and process data into defensible validation evidence
Align validation deliverables to audit expectations and regulatory standards

Optional Add-Ons

Post-Workshop Validation Review: Follow-up consultation to review your first validation package.
Template Customization Package: Tailored SOP, WKI, and protocol templates aligned to your QMS.
Team Certification: Certificate of completion for individuals or departments completing the full workshop.

Get a Quote

Every organization's compliance journey is different — your quote should be too.

Share a few details about your project at contact@heurnova.com, and we'll prepare a customized quote.

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