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Verification vs. Validation - Product, Process, Software and QMS From GlobalCompliancePanel

Education

(Free Press Release) GlobalCompliancePanel, a leading regulatory and compliance training gateway, will host a two-day, in-person seminar on the topic, “Verification vs. Validation - Product, Process, Software and QMS” on January 17 and 18 at Hilton Grand Vacations Suites at the Flamingo, Las Vegas, Nevada. John E. Lincoln, Medical Device and Regulatory Affairs consultant will be the speaker at this seminar.

Verification vs. Validation - Product, Process, Software and QMS From GlobalCompliancePanel


      

 

Course Agenda:

The FDA has new and tougher regulatory requirements for a company’s Master Validation Plan for major key inputs and CGMP deficiencies. This seminar will address these. It seeks to demonstrate "Product Risk Based V&V" by sufficient, targeted and documented risk-based V&V test case elements/scripts. It will help participants evaluate these elements against ISO 14971 and ICH Q9 for hazard analysis and product risk management.

In arriving at its goal, this seminar will evaluate aspects such as 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,software VT&Vet al, all to make sure that key FDA requirements are not overlooked. This course will alsoconsider QMS and 21 CFR Part 11, whose practical application will be made during the two days of interactive training.

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Course Description:

Day 1 - 17th January 2013

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 - 18th January 2013

Lecture 9: Software V&V documentation "model"

Lecture 10: Software V&V protocols - "black box", "white box"

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

Lecture 12: Summary of morning discussion

Lecture 13: Group activity on 1) hardware/equipment, and 2) software V&V protocols

Lecture 14: Review of group activity and Q&A

Lecture 15: Course summary discussion

Lecture 16: Summary of morning discussion

Lecture 17: Group activity on the MVPs

Lecture 18: Review of group activity and Q&A

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Purpose of the seminar

This session helps participants:

o Understand Verification and Validation, differences and how they work together;

o Discuss recent regulatory expectations;

o Know how to document a "risk-based" rationale, and use it in a resource-constrained environment;

o Determine key "milestones" and "tasks" in a project;

o Locate and document key subject "inputs";

o Compile "generic" Master and Individual Validation Plans;

o Learn the key element of a Product V&V File/Protocol;

o Understand how to develop Process and/or Production/Test Equipment V&V Files/Protocols;

o Get a grasp of basic Test Case construction;

o Understand sample sizes and their justification;

o Learn the key elements of Software V&V expected by the FDA and how to document;

o Deal with hardware and software vendors, sales and marketing

o Consider a field-tested software V&V documentation "model";

o See how to compile QMS Electronic Records and Electronic Signatures V&Vs to satisfy 21 CFR Part 11.

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About the Speaker:

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.

John has also managed pilot production, regulatory affairs, product development/design control, 510(k) submissions and risk management per ISO 14971 and implemented projects. With over 28 years of experience in the FDA-regulated medical products industry, he has worked from start-ups to Fortune 100 companies, including Abbott Laboratories, Hospira, and Tyco/Mallinckrodt.

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Who will benefit:

This workshop will provide valuable assistance to all regulated companies that need to review and modify their Master Validation Planning and V&V activities/plan(s).This information addresses medical devices, pharmaceutical, diagnostic, and biologics requirements and implementation. The employees who will benefit include:

o Senior and middle management and staff

o Regulatory Affairs

o Quality Assurance or Quality Control Professionals

o QA/QC

o IT/IS

o R&D

o Production Management

o Manufacturing Engineers

o Process Engineers

o Software Engineers

o Project Managers

o Hardware and software vendors, sales and marketing

o Any professional tasked with V&V responsibilities

DATE AND VENUE:

January 17 and 18, 2013

Seminar Timings: 9am to 6pm EST

Venue:Hilton Grand Vacations Suites at the Flamingo

Address: 3575 Las Vegas Boulevard South, Las Vegas, Nevada, 89109

Price –$ 1495;

Group discounts available in the following pattern:

Send two attendees: Get a discount of 10%

Send three to six attendees: Get a discount of 20%

Send seven to 10 attendees: Get a discount of 25%

Send 10 attendees or more off: Get a discount of 30%

To avail the above group discounts, all the participants should register by making a single payment.Please contact Customer Care at 1800 447 9407

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Contact Information:

Event Coordinator

Toll free: 1800 447 9407

Fax: 302 288 6884

Email: This e-mail address is being protected from spambots. You need JavaScript enabled to view it

Website:https://www.globalcompliancepanel.com/

GlobalCompliancePanel

NetZealous

USA Livermore Common, Fremont,

CA 94539, USA

Phone: 1800 425 9407

 




Verification vs. Validation - Product, Process, Software and QMS From GlobalCompliancePanel

Source: Press Release

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