Global

CompliancePanel

Knowledge, a Way Forward

2-day In-person Seminar:

Verification vs. Validation - Product Process Software and QMS

Las Vegas, NV

October 15th & 16th, 2015

9:00 AM to 6:00 PM

Course " Verication vs. Validation - Product Process Software and QMS " has been pre-approved by RAPS as eligible for up
to 12 credits towards a participant's RAC recertication upon full completion.

John E Lincoln
Consultant, Medical device and Regulatory affairs,
John E. Lincoln is a medical device and regulatory affairs consultant. He has helped companies to implement or modify their
GMP systems and procedures, product risk management, U.S. FDA responses. In addition, he has successfully designed,
written and run all types of process, equipment and software qualications/validations, which have passed FDA audit or
submission scrutiny, and described in peer-reviewed technical articles, and workshops, world wide. John has also managed
pilot production, regulatory affairs, product development/design control, 510(k) submissions, risk management per ISO
14971, and projects; with over 28 years of experience in the FDA-regulated medical products industry - working with startups to Fortune 100 companies, including Abbott Laboratories, Hospira, Tyco/Mallinckrodt. He is a graduate of UCLA.

Overview
This course will review the company Master Validation Plan for major key inputs and CGMP deciencies. It will address the
FDA's newer and tougher regulatory stance. This course's aim is to prove "Product Risk Based V&V" by sufcient, targeted
and documented risk-based V&V test case elements/scripts. It will teach participants to evaluate its elements against ISO
14971 and ICH Q9 for hazard analysis and product risk management.

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CompliancePanel

Knowledge, a Way Forward

Agenda:
DAY ONE

DAY TWO

Master Validation Planning and the Master

Validation Plan(s)

Software V&V documentation "model"

Software V&V protocols - "black box", "white box"

Product, Process / Equipment Hardware V&V

Electronic Records and Electronic Signatures
(Part 11)

Product / Device V&V

Summary of morning discussion

Software V&V
Quality Management System / 21 CFR Part 11

Group activity on 1) hardware / equipment, and

2) software V&V protocols

V&V

Review of group activity and Q&A

Summary of morning discussion
Course summary discussion
Group activity on the MVPs
Summary of morning discussion
Review of group activity and Q&A
Group activity on the MVPs
Review of group activity and Q&A

Why Should Attend

Understand Verication 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 justication;
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

Who Will Benet:

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 benet include:
Senior and middle management and staff
Regulatory Affairs
Quality Assurance or Quality Control Professionals
QA/QC
IT/IS

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Pricing List

Knowledge, a Way Forward

Group participations

Price for One Delegate pass Price:

2 Attendees to get offer

10%

$ 1,895.00

3 to 6 Attendees to get offer

20%

Register Now

7 to 10 Attendees to get offer

25%

10+ Attendees to get offer

30%

**Please note the registration will be closed 2 days (48 Hours) prior to
the date of the seminar.

What you will get

Learning Objectives
Participation certificates

Payment Option
Credit Card: Use the Link to make Payment by
Visa/Master/American Express card click on the
register now link

Interactive sessions with the US expert

Post event email assistance to your queries.

Check: Kindly make the check payable to

NetZealous DBA GlobalCompliancePanel and
mailed to 161 Mission Falls Lane, Suite 216,

Special price on future purchase of web

Fremont, CA 94539, USA

based trainings.
Special price on future consulting or expertise
services.
Special price on future seminars by
GlobalCompliancePanel.

PO: Please drop an email to

support@globalcompliancepanel.com or call the
our toll free +1-800-447-9407 for the invoice and
you may fax the PO to 302 288 6884

Seminar Kit includes presentation handout,

Wire Transfer: Please drop an email to

ID card, brochure, trainings catalog, notepad

support@globalcompliancepanel.com or call our

and pen.

toll free +1-800-447-9407 for the wire transfer

Networking with industry's top notch professionals

information

Contact Information: Event Coordinator

Kindly get in touch with us for any help or information.

NetZealous LLC, DBA GlobalCompliancePanel

Look forward to meeting you at the seminar

161 Mission Falls Lane, Suite 216, Fremont, CA 94539, USA

GlobalCompliancePanel

Toll free: +1-800-447-9407

Fax: 302 288 6884
Email: support@globalcompliancepanel.com