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 3. VERIFICATION AND VALIDATION - PRODUCT, EQUIPMENT / PROCESS, SOFTWARE AND QMS


VERIFICATION AND VALIDATION - PRODUCT, EQUIPMENT / PROCESS, SOFTWARE AND QMS

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AGENDA

DAY 1 (10 AM to 4 PM)
 * 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)



DAY 2 (10 AM to 4 PM)
 * 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


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About The Course:

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

Who Should Attend:

 * 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



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V&V Verification Validation Medical Devices training equipment validation course
process verification seminar
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