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Net Zealous

USA Seminar 2013 at Las Vegas

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

John E. Lincoln On 17th and 18th January, 2013 at Las Vegas

About GlobalCompliancePanel: GlobalCompliancePanel is a training source that delivers diverse, high quality regulatory & compliance trainings. These trainings are simple while being relevant and cost-effective while being convenient. GlobalCompliancePanel imparts knowledge of best practices across a broad range of user-friendly mediums such as webinars, seminars, conferences and tailored, individualized consulting. These help organizations and professionals implement compliance programs that meet regulatory demands and put business processes in place. Through our trainings, we bring together the regulators or experts on regulation on the one hand, with the community that needs to learn or be aware of those regulations, on the other. Our services benefit the Medical Devices, Pharmaceutical, Bio Technology, Food Safety, Financial Accounting Standards, and IT Control & PCI Industries. Our clientele includes companies such as J&J, Pfizer, Sanofi Aventis, Pall Corp, Abbott, Merck, Bayer, and Roche, some of which are Fortune 500 companies. Professionals who undergo trainings from GlobalCompliancePanel exhibit a vastly improved quality of life in which there is increased productivity and professional growth. Some 30,000 professionals have gained from more than 500 training courses we have conducted till now.

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USA Seminar 2013 at Las Vegas James E. Russell Director of Regulatory Affairs, RJR Consulting Inc

About Speaker: John E. Lincoln is Principal of J. E. Lincoln and Associates LLC, a consulting company with over 30 years experience in U.S. FDA-regulated industries, 16 of which as a full-time consultant. John has worked with companies from start-up to Fortune 100, in the U.S., Mexico, Canada, France, Germany, Sweden, China and Taiwan. He specializes in quality assurance, regulatory affairs, QMS problem remediation and FDA responses, new / changed product 510(k)s, process / product / equipment V&V including QMS and software validations, ISO 14971 product risk management files / reports, Design Control / Design History Files, Technical Files. He's held positions in Manufacturing Engineering, QA, QAE, Regulatory Affairs, to the level of Director and VP (R&D). In addition, John has prior experience in military, government, electronics, and aerospace. He has published numerous articles in peer reviewed journals, conducted workshops and webinars worldwide on V &V, CAPA, 510(k)s, risk analysis / management, FDA / GMP audits, root cause analysis, and others. John is a graduate of UCLA.

Venue Date and Venue: January 7th and 8th, 2013 at Las Vegas


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USA Seminar 2013 at Las Vegas Overview: Review the company Master Validation Plan for major key inputs and CGMP deficiencies. Address the FDA's newer and tougher regulatory stance. Prove "Product Risk Based V&V" by sufficient, targeted and documented risk-based V&V test case elements / scripts. Evaluate its elements against ISO 14971 and ICH Q9 for hazard analysis and product risk management. Evalute 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. 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. The QMS and 21 CFR Part 11 are considered. Make practical application in two hands-on sessions. Seminar Content: Day 1 - 17th January 2013

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

Conference Timings: 9am to 6 pm EST Day 2 - 18th January 2013

Lecture 9: Software V&V documentation "model"

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

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

Lecture 3: Product / Device V&V Lecture 4: TSoftware V&V

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

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

Lecture 12: Summary of morning discussion

Lecture 6: Summary of morning discussion

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

Lecture 7: Group activity on the MVPs Lecture 8: Review of group activity and Q&A

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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USA Seminar 2013 at Las Vegas What you get:

Pricing List:

1. 2. 3. 4. 5. 6. 7. 8.

Learning Objectives Participation certificates Interactive sessions with the US expert Post event email assistance to your queries. Special price on future purchase of web based trainings. Special price on future consulting or expertise services. Special price on future seminars by GlobalCompliancePanel. Seminar Kit – includes presentation handout, ID card, brochure, trainings catalog, notepad and pen. 9. Networking with industry's top notch professionals

1. Price for One Delegate pass $1695 (Between December 18th to January 16th)

-------------------------------------2. Early bird price for one Delegate pass $1495 (Between November 26th to December 17th)

-------------------------------------3. For discounts on multiple registrations, contact customer care at 1800 447 9407

Companies that will benefit:  Drug and Biologics Companies

Professionals who will benefit:

 PAT Teams

 Executives/Managers within Dietary

 Process Development

Supplement or Natural Product companies

Payment Options:

 Regulatory Compliance Professionals in

Credit Card: Use the Link to make Payment by Visa/Master/American Express card click on the register now link  Check: Kindly make the check payable to NetZealous DBA GlobalCompliancePanel and mailed to 1000 N West Street, Suite 1200, Wilmington, DE 19801  PO: Please drop an email to or call the our toll free 1800 447 9407 for the invoice and you may fax the PO to 302 288 6884  Wire Transfer: Please drop an email to or call our toll free 1800 447 9407 for the wire transfer information

the Supplements or Natural Products area  Quality Assurance or Quality Control

Professionals  Dietary Supplement or Natural Product

Manufacturers & Distributors  Sales/Marketing Personnel in the

Supplement or Natural Product Industries

Contact Information: Event Coordinator Toll free: 1800 447 9407 Fax: 302 288 6884 Email: GlobalCompliancePanel NetZealous 1000 N West Street, Suite 1200, Wilmington, DE 19801..

Kindly get in touch with us for any help or information. Look forward to meeting you at the seminar Team GlobalCompliancePanel

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

This course will review the company Master Validation Plan for major key inputs and CGMP deficiencies. It will address the FDA's newer and t...

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