2-day In-person Seminar on Verification vs. Validation - Product, Process, Software and QMS

GlobalCompliancePanel to hold two-day, in-person seminar in Las Vegas on the topic, “Verification vs. Validation –Product, Process, Software and QMS” on May 2 and 3, 2013(Thursday & Friday).

Online PR News – 04-April-2013 – Fremont – From:
NetZealous LLC,
161| Mission Falls Lane| Suite 216, Fremont| CA 94539
Ph: 800-447-9407
Website: http://www.globalcompliancepanel.com/
Venue, date and timings: The venue for this seminar is the Hilton Grand Vacations Suites at the Flamingo,3575 Las Vegas Boulevard South, Las Vegas, Nevada, 89109. The seminar will be on May 2 and 3, from 9 A.M to 6 P.M PDT.
What the seminar is about:
The speaker, John E. Lincoln, will conduct this two-day course on company Master Validation Plan for key inputs and CGMP deficiencies. The FDA has come up with a newer and tougher regulatory stance. This course addresses this. It proceeds to give participants an understanding of how to prepare a “risk based” document and use it in a resource constrained environment.
The expert will then go on to demonstrate “Product Risk Based V&V” by sufficient, targeted and documented risk-based V&V test case elements/scripts. More importantly, the speaker will help participants understand and evaluate the elements of V and V in relation to ISO 14971 and ICH Q9 for hazard analysis and product risk management.
This seminar will help participants:
a) Determine key “milestones” and “tasks” in a project;
b) Locate and document key subject “inputs”;
c) Compile “generic” Master and Individual Validation Plans;
d) Learn the key element of a Product V&V File/Protocol;
e) Develop Process and/or Production/Test Equipment V&V Files/Protocols;
f) Get a grasp of basic Test Case construction;
g) Understand sample sizes and their justification;
h) Learn the key elements of Software V&V expected by the FDA and how to document;
i) Deal with hardware and software vendors, sales and marketing
j) Consider a field-tested software V&V documentation “model”
Participants will also understand how to compile QMS Electronic Records and Electronic Signatures V&Vs to satisfy 21 CFR Part 11 through the use of practical application in two hands-on sessions.
About the Speaker:
John E. Lincoln, 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.
This is the agenda of this seminar:
Day 1
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
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
For whom:
This seminar will benefit professionals in/among the following areas:
1. Senior and middle management and staff
2. Regulatory Affairs
3. Quality Assurance or Quality Control Professionals
4. QA/QC
5. IT/IS
6. R&D
7. Production Management
8. Manufacturing Engineers
9. Process Engineers
10. Software Engineers
11. Project Managers
12. Hardware and software vendors, sales and marketing
13. Any professional tasked with V&V responsibilities
About GlobalCompliancePanel:
GlobalCompliancePanel (GCP) is a specialized offering from NetZealous LLC, a Technology and Business Process Solutions and Services Company registered in Fremont, CA. It is a fountainhead for Continuous Professional Education, compliance training and consulting. GCP offers a broad range of high quality regulatory and compliance-related services relating to Medical Devices, Pharmaceutical, FDA, Food, PCI industries, and SOX. Some of the Governing Areas its webinars cover are GxP (Manufacturing / Clinical / Lab), EU and ISO.
These seminars are an extension of online trainings, at which GCP has conducted around 700 webinars since inception on a variety of topics for these industries /verticals. More than 30,000 professionals have benefited from these trainings. GlobalCompliancePanel’s trainings are focused, flexible and tailored to the client’s need.
This is the next in a series of regulatory and compliance related seminars that GlobalCompliancePanel has been organizing all over the US. Its previous seminars have met with resounding success. GlobalCompliancePanel’s seminars have helped participants reach their career milestones. In bringing globally renowned experts in the field of regulatory compliance and executives in the industry together, GlobalCompliancePanel fosters a learning experience. With trainings that are focused and relevant, GlobalCompliancePanel seeks to serve as a bridge in the area of continuous professional education for regulatory and compliance-related fields.
Price:$1,495.00 per participant. Discounts are available for group participation in the following manner:
For two attendees: 10% discount
For three to six attendees: 20% discount
For seven to 10 attendees: 25% discount
For more than 10 attendees: 30% discount
To avail the above group discounts, all the participants should register by making a single payment.
Please note the registration will be closed two days (48 hours) prior to the start date of the seminar.
Call our representative on 1800 447 9407 to have your seats confirmed.
Contact Information:

Event Coordinator
Toll free: 1800 447 9407
Fax: 302 288 6884
Email: support@globalcompliancepanel.com
Website: https://www.globalcompliancepanel.com
LIVE CHAT SUPPORT- http://www.globalcompliancepanel.com/chat/client.php
NetZealous LLC,
161| Mission Falls Lane| Suite 216, Fremont| CA 94539