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

DUBLIN, May 25, 2022--(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

About ResearchAndMarkets.com

ResearchAndMarkets.com is the world's leading source for international market research reports and market data. We provide you with the latest data on international and regional markets, key industries, the top companies, new products and the latest trends.

View source version on businesswire.com: https://www.businesswire.com/news/home/20220525005780/en/

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