VERIFICATION AND VALIDATION - PRODUCT, EQUIPMENT / PROCESS, SOFTWARE AND QMS 2022
Dates: JUNE 27 - 28, 2022
Time (Eastern Time US): 10 AM to 4 PM
Time (Central Europe): 4 PM to 10 PM
Duration: 2 DAYS
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:
Products;
Process;
Production Equipment;
Monitoring and Test Equipment;
Software;
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
WHO SHOULD ATTEND
Regulatory Affairs Departments
Quality Assurance Departments
Quality Control Departments
IT/IS Departments
Research and Development Departments
Production Departments
Manufacturing Departments
Engineering Departments
Process Engineers
Software Engineers
Project Managers
Hardware and software vendors, sales and marketing
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
