Verification and Validation - Product, Equipment / Process, Software and QMS
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
As Various parts of the world are still battling the Coronavirus (COVID-19), we are conducting the class 100% online.
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Team
John E. Lincoln
John E. Lincoln, is Principal of J. E. Lincoln and Associates LLC, a consulting company with over 36 years experience in U.S. FDA-regulated industries, 22 of which are as an independent consultant. John has worked with companies from start-up to Fortune 100, in the U.S., Mexico, Canada, France, Germany, Sweden, China and Taiwan. He specializes in quality assurance, regulatory affairs, QMS problem remediation and FDA responses, new / changed product 510(k)s, process / product / equipment QMS and software validations, ISO 14971 product risk management files / reports, Design Control / Design History Files, Technical Files, CAPA systems and analysis. He’s held positions in Manufacturing Engineering, QA, QAE, Regulatory Affairs, to the level of Director and VP (R&D). In addition, John has prior experience in military, government, electronics, and aerospace. He has published numerous articles in peer reviewed journals, conducted workshops and webinars worldwide on CAPA, 510(k)s, risk analysis / management, FDA / GMP audits, validation, root cause analysis, and others. He writes a recurring column for the Journal of Validation Technology. John is a graduate of UCLA.
Seminar Description
ABOUT THE COURSE
- 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
Agenda
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)
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
Registration Options
2-Day Seminar on Verification and Validation - Product, Equipment / Process, Software and QMS
- Date: 6/27/2022 10:00 AM
- Location Online Event
