DUBLIN--(BUSINESS WIRE)--The "2-Day Seminar on Verification and Validation - Product, Equipment / Process, Software and QMS" training has been added to ResearchAndMarkets.com's offering.
The seminar helps participants to 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"
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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
Key Topics Covered:
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 4th, 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)
DAY 2
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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
The course is suitable for:
- 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
For more information about this training visit https://www.researchandmarkets.com/r/iqh5gn
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