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Seminar on Verification vs. Validation - Product Process Software and QMS  

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By:

Global Compliance Panel   

For:

Senior and middle management and staff, Regulatory Affairs, Quality Assurance or Quality Control Professionals, QA/QC, IT/IS, R&D, Production Management, Manufacturing Engineers, Process Engineers, Software Engineers, Project Managers, Hardware and software vendors, sales and marketing, Any professional tasked with V&V responsibilities

Cost:   

see Registration info for seminar cost, group discount etc.

Seminar Summary:

This course will review the company Master Validation Plan for major key inputs and CGMP deficiencies. It will address the FDA's newer and tougher regulatory stance. (see full course description)

 

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Training Course Syllabus:


Verification vs. Validation - Product Process Software and QMS

Course Description:

This course will evaluate different field-tested, U.S. FDA-reviewed V&V protocols; how to employ equipment/process Requirements Specs / DQs, IQs, OQs, and PQs, or their equivalents per ASTM E2500, all against a background of limited company resources.

It will review a matrix that simplifies "as-product", in-product", process and equipment, et al, software VT&V, to assure key FDA requirements are not overlooked. While considering the QMS and 21 CFR Part 11; this course will make practical application of these same in two hands-on sessions.

Why you should attend:

This session helps participants:
Understand Verification and Validation, differences and how they work together;
Discuss recent regulatory expectations;
Know how to document a "risk-based" rationale, and use it in a resource-constrained environment;
Determine key "milestones" and "tasks" in a project;
Locate and document key subject "inputs";
Compile "generic" Master and Individual Validation Plans;
Learn the key element of a Product V&V File/Protocol;
Understand how to develop Process and/or Production/Test Equipment V&V Files/Protocols;
Get a grasp of basic Test Case construction;
Understand sample sizes and their justification;
Learn the key elements of Software V&V expected by the FDA and how to document;
Deal with hardware and software vendors, sales and marketing
Consider a field-tested software V&V documentation "model";
See how to compile QMS Electronic Records and Electronic Signatures V&Vs to satisfy 21 CFR Part 11.

Agenda:

Day 1 Schedule:

Lecture 1:
Master Validation Planning and the Master Validation Plan(s)

Lecture 2:
Product, Process / Equipment Hardware V&V

Lecture 3:
Product / Device V&V

Lecture 4:
Software V&V

Lecture 5:
Quality Management System / 21 CFR Part 11 V&V

Lecture 6:
Summary of morning discussion

Lecture 7:
Group activity on the MVPs

Lecture 8:
Review of group activity and Q&A

Day 2 Schedule:

Lecture 1:
Software V&V documentation "model"

Lecture 2:
Software V&V protocols - "black box", "white box"

Lecture 3:
Electronic Records and Electronic Signatures (Part 11)

Lecture 4:
Summary of morning discussion

Lecture 5:
Group activity on 1) hardware / equipment, and 2) software V&V protocols

Lecture 6:
Review of group activity and Q&A

Lecture 7:
Course summary discussion

Lecture 8:
Summary of morning discussion

Lecture 9:
Group activity on the MVPs

Lecture 10:
Review of group activity and Q&A

Speaker:

John E Lincoln
Consultant, Medical device and Regulatory affairs,

John E Lincoln is Principal of J. E. Lincoln and Associates LLC, a consulting company. John, a graduate of UCLA, is a medical device and Regulatory Affairs consultant. He has helped companies to implement or modify their GMP systems and procedures, product risk management and U.S. FDA responses. In addition, he has successfully designed, written and run all types of process, equipment and software qualifications/validations, which have passed FDA audit or submission scrutiny, and have been described in peer-reviewed technical articles and workshops worldwide.

Seminar Summary:

This course will review the company Master Validation Plan for major key inputs and CGMP deficiencies. It will address the FDA's newer and tougher regulatory stance. (see full course description)

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