2-Day Virtual Seminar on Verification and Validation - Product, Equipment / Process, Software and QMS (June 27-28, 2022) - ResearchAndMarkets.com

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"
• 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

• 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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