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Just Added!
Tuesday, February 13


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





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

By Audiopence
124 followers
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DATE AND TIME

February 13 · 7pm - February 14 · 11pm CET


LOCATION

Online




REFUND POLICY

Contact the organizer to request a refund.



ABOUT THIS EVENT

 * 1 day 4 hours
 * Mobile eTicket

Description

This session is scheduled for the 13th and 14th of Feb 2024. The webinar will
start from 1.00 pm EST to 5.00 pm EST on both days.

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


AGENDA

 * Introductions; Housekeeping Announcements; Workbook Walk-Through
 * V&V Planning; The Master Validation Plan; The Individual Validation Plan
 * Break and Q & A
 * “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”
 * Break and Q & A
 * 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
 * Course Highlights and Q & A


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





TAGS

 * Online Events
 * Things To Do Online
 * Online Classes
 * Online Other Classes
 * #product
 * #software
 * #validation
 * #equipment
 * #verification


ABOUT THE ORGANIZER

Organized by
Audiopence
124 followers
 * Contact
 * Follow



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$699 – $1,999
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