Dates: JUNE 27 - 28, 2022
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.
Verification and Validation - Product, Equipment / Process, Software and QMS

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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.

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;
  • 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
  • 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
10:00 AM - 04:00 PM
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 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)

10:00 AM - 04:00 PM
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

2-Day Seminar on Verification and Validation - Product, Equipment / Process, Software and QMS

  • Date: 6/27/2022 10:00 AM
  • Location Online Event

Tickets


Ticket Type
Qty
1 Attendee - Live only
$1200.00
0
2 Attendees - Live only
$2200.00
0
3 Attendees - Live only
$3100.00
0
4-10 Attendees - Live only
$4900.00
0
Recording Only - Unlimited Viewers
$3900.00
0

Total

$0.00