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MODULE 3: PLANNING BEFORE TESTING: VMP, CATEGORISATION AND RISK

What is this course about?

Who is this mini-course for?

Teaching goals

SLIDE 1 — THE RISK ASSESSMENT WITH TOMORROW'S DATE

Signed After the Fact

SLIDE 2 — PLAN, CATEGORISE, ASSESS RISK

Decide the Rigour Before You Earn the Right to Test

SLIDE 3 — CASE STUDY: WHAT CATEGORY IS THIS?

"It's Just Configuration"

SLIDE 4 — DOING IT CORRECTLY

Plans That Hold Up

SLIDE 5 — KNOWLEDGE CHECK AND TAKEAWAYS

Prove It

Part C — Top five takeaways

Transition

Part A — Quiz (5 questions; use Q1, Q2 and Q5 on screen for the 5-minute cut)

Q1. A risk assessment is dated after the first protocol execution. The testing itself was thorough. What is the core problem?

Q2. A configured commercial product has 600 lines of site-written script performing a GxP calculation. What is the most defensible treatment?

Q3. Which acceptance criterion is adequate?

Q4. What is the correct relationship between GAMP®5 categorisation and testing depth?

Q5. A validation plan has no "out of scope" section. Why does this matter?

Survey/Feedback

Part B — Reflection

10-POINT AUDIT CHECKLIST — MODULE 3

Welcome to "Validation Planning, Risk Assessment, and GAMP 5 System Categorization," a highly specialized course designed for professionals in regulated industries who need to master the foundational elements of computer system validation (CSV). Before you even begin testing, the rigor of your validation effort must be clearly defined and documented.

Welcome to "Validation Planning, Risk Assessment, and GAMP 5 System Categorization," a highly specialized course designed for professionals in regulated industries who need to master the foundational elements of computer system validation (CSV). Before you even begin testing, the rigor of your validation effort must be clearly defined and documented. This course dives deep into the critical planning phases that dictate the success, efficiency, and compliance of your validation projects. You will explore the intricacies of Validation Master Plans (VMP), GAMP® 5 system categorization, and risk assessments. Through real-world case studies—like determining if 600 lines of site-written script is truly "just configuration"—and practical examples of common industry pitfalls (such as signing risk assessments after the fact), you will learn how to build validation plans that hold up under strict audit scrutiny. We will cover how to establish defensible acceptance criteria, understand the correct relationship between GAMP 5 categorization and testing depth, and discover why defining what is "out of scope" is just as important as defining what is in scope. Complete with a comprehensive 10-point audit checklist, interactive quizzes, and actionable takeaways, this course ensures you have the confidence and knowledge to plan, categorize, and assess risk correctly before you earn the right to test.

CSV Module 3: Validation Planning, Risk Assessment, and GAMP 5 System Categorization

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            <p>Effective computerized system validation relies entirely on the foundational planning established before a single test script is executed. This course provides a comprehensive examination of validation planning, risk assessment methodologies, and GAMP 5 system categorization. For validation specialists, QA reviewers, and IT application owners, understanding how to properly define the scope and rigor of validation efforts is critical to maintaining regulatory compliance. A robust validation plan serves as the strategic roadmap, ensuring that all subsequent activities are justified, traceable, and aligned with stringent industry standards.</p>

<p>Throughout this curriculum, participants will explore the critical sequence of validation activities, emphasizing the absolute necessity of conducting risk assessments and defining system categories prior to testing. By analyzing real-world scenarios—such as the compliance pitfalls of retroactive risk assessments and the complexities of systems erroneously dismissed as "just configuration"—project managers, engineering staff, and business SMEs will learn to construct validation plans that withstand rigorous audit scrutiny. The program culminates in targeted knowledge checks, actionable takeaways, and a comprehensive 10-point audit checklist designed to reinforce defensible compliance strategies and ensure that all stakeholders fully comprehend the documentation they are tasked with approving.</p>
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