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  Verification and Validation - Product, Equipment / Process, Software, QMS+
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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;

Learning 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


Day 1

09:00 AM Introduction (personal / course information)

 09:30 AM  Session 1 – Master V& V Planning (ends with a short break)

  • V&V; “Working” Definitions
  • Key Areas in Product Validation
  • Key Equipment, Process, Software and QMS V&V Activities
  • The Master Validation Plan
  • Requirements
  • Protocols / Test Cases; Proving (V&V) the Requirements
  • DQ, IQ, OQ, PQs, and PPQs
  • The Test Report
  • Life Cycles; Regulatory “Hot Buttons”

 11:00 AM Session 2 – Human Factors Engineering (ends with a short break}

  • IEC 62366-1 and -2
  • The “Interface”
  • The 9 Stages of Usability / Human Factors Engineering
  • The UE/HF File

 12:00 Noon Session 3 - Data Integrity and Cybersecutrity

  • Data Integrity / GDP
  • Cybersecurity

 01:00 PM End, Day 1

Day 2

09:00 AM Session 4 – Software / Firmware V&V (ends with a short break)

  • Documentation – The 11 Elements
  • V&V “Models” – For the 4 Types of SW Validations
  • 21 CFR Part 11, “Electronic Records / Signatures”
  • Legacy, Hybrid, New and ER / ES Systems
  • Life Cycle and “Cloud” Considerations
  • Types of Testing
  • Test Case Examples
  • A “Typical” Test Report
  • GAMP® 4 & 5
  • IEC 62304

 10:30 AM Session 5 – Product Risk Management (ends with a short break)

  • Patient Hazard / Risk Management per ISO 14971:2019
  • Risk – What?
  • QMS / System Level
  • Device / Product Level
  • File / Review (Benefit / Risk)
  • Narrative / Descriptive Information
  • Hazards
  • FTA
  • D-, P-, U-FME[C]A + Normal
  • The Product Risk Management File / Report / Review

 12:00 Noon Session 6 – Project Management

  • Work Breakdown Structure
  • Gantt
  • CPM
  • PERT
  • Usage in FDA-regulated industries; Examples

 12:50 PM Conclusion

  • Documentation Hierarchy
  • Course summary
  • Final Q & A

 01:00 PM End, Day 2

All time in PDT

Who will Benefit

This seminar will provide valuable assistance to all regulated companies that need to review and modify their Master Validation Planning and Plan(s). While this information is focused on Medical Devices, its principles apply to personnel / companies in the Pharmaceutical, Diagnostic, and Biologics fields. The employees who will benefit include:

  • Senior and middle management and staff
  • Regulatory Affairs
  • QA/QC
  • IT/IS
  • R&D
  • Production Management
  • Manufacturing Engineers
  • Process Engineers
  • Software Engineers
  • Project Managers
  • Hardware and software vendors, sales and marketing

FDA Faculty John E. Lincoln

Faculty John E. Lincoln

Medical Devices / Regulatory Consultant; also pharma and dietary supplements

Saint George, Utah

John E. Lincoln is Principal of J. E. Lincoln and Associates LLC, a consulting company, with over 32 years experience in U.S. FDA-regulated industries, 18 of which as a full time independent FDA-regulated industry consultant. Mr. Lincoln 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 / CGMP audits and problem remediation and FDA responses, new / changed product 510(k)s, process / product / equipment including QMS and software validations, ISO 14971 product risk management files / reports, Design Control / Design History Files, Technical Files. He’s held positions in Manufacturing Engineering, QA, QAE, Regulatory Affairs, to the level of Director and VP (R&D).

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