Verification and Validation - Product, Equipment / Process, Software and Qms

Verification and Validation - Product, Equipment / Process, Software and Qms is organized by Eventura World and will be held from Jun 27 - 28, 2022.

Course Director: JOHN E. LINCOLN

About the Course:
Develop / review a company's Master Validation Plan for major cGMP deficiencies. Address the U.S. FDA's newer and tougher regulatory stance. One major failing is lack of sufficient or targeted risk-based V&V planning:

• Start with a Master Validation Plan;
• Evaluate its elements against ISO 14971 and ICH Q9 for hazard analysis and product risk management;
• The Individual V&V Plan;
• V&V Project Management;
• “Risk-based” per ISO 14971, ICH Q9, and/or GAMP/JETT;
• Two key input analysis tools;
• Change control and “drawing a line in the sand”;
• Develop meaningful V&V Files and Protocols for:
1. Products;
2. Process;
3. Production Equipment;
4. Monitoring and Test Equipment;
5. Software;
6. Quality Management System – 21 CFR 11, Electronic Records / Signatures;
• The roles of different V&V protocols;
• How to employ equipment / process DQs, IQs, OQs, and PQs, or their equivalents,
• V&V against a background of limited company resources;
• The FDA's 11-element software matrix simplifies "as-product", in-product", process and equipment, et al, software VT&V;
• Assure key U.S.FDA and comparable EU MDD / ISO requirements are not overlooked;
• The QMS and 21 CFR Part 11, “Electronic Records / Signatures” V&V;
• Hands-on examples and activities show real-world implementation of useful principles, tools and templates;

Seminar Objectives:
• Understand Verification and Validation, differences and how they work together
• Develop a “Working Definition” of V&V, Qualification, and related terms
• Discuss recent regulatory expectations
• How to document a “risk-based” rationale, and use it in a resource-constrained environment
• Determine key “milestones” and “tasks” in a project; device sample provided
• Locate and document key subject “inputs”
• Compile “generic” Master and Individual Validation Plans
• Lean the key element of a Product V&V File / Protocol
• How to develop Process and/or Production / Test Equipment V&V Files / Protocols
• Basic Test Case / Script construction
• Sample sizes and their justification
• Lean the key 11 elements of Software V&V expected by the FDA and how to document
• See how to compile QMS Electronic Records and Electronic Signatures V&Vs per 21 CFR 11 and related CGMPs

10:00 AM - 04:00 PM
Day 1:
V&V Planning; The Master Validation Plan; The Individual Validation Plan

“Risk-based” -- Evaluate its elements against ISO 14971 and ICH Q9 for hazard analysis and product risk management – File Narrative, Hazard Analysis, FTA, 3 FMECAs (Design, Process, Use[r], and a possible 4 th , Software); also GAMP / JETT approaches

V&V Project Management – “Milestones” and “Tasks”

Two key input analysis tools – The Process Map / Flow Chart, and the Cause and Effect Diagram (templates supplied)

Change control and “drawing a line in the sand”

Elements of a V&V File / Protocol:
• Intro / Purpose / Scope
• Protocol Material / Equipment
• DQ or Requirements Specs
• ASTM2500
• IQ (or equivalent)
• OQ (or equivalent)
• PQs (or equivalent)

10:00 AM - 04:00 PM:
Day 2:
Develop and Employ Meaningful V&V Files and Protocols for:
• Products;
• Process;
• Production Equipment;
• Monitoring and Test Equipment;
• Software;
• Quality Management System – 21 CFR 11, Electronic Records / Signature

The FDA’s 11-element software matrix simplifies "as-product", in-product", process and equipment software V&V – what they mean, how to research and how to document

The QMS, ERP and 21 CFR Part 11 V&V – “Cloud” Issues; “White box” and “Black box” Testing; Basic Test Case Development

V&V, Senior Management / IP and Limited Company Resources

U.S. FDA Audit Issues and “Responsible” Documentation

Interactive Discussions and Q&A Session