Verification vs. Validation

2-day In-person Seminar: Location: Las Vegas NV | March 27-28, 2014 Net Zealous About GlobalCompliancePanel: GlobalCompliancePanel is a training source that delivers diverse, high quality regulatory & compliance trainings. These trainings are simple while being relevant and cost- e f f e c t i v e w h i l e b e i n g c o n v e n i e n t . 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. www.globalcompliancepanel.com All rights are reserved © GlobalCompliancePanel. Our services benef i t 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. Profess iona ls who undergo t ra in ings f rom 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 By: Consultant, Medical device and Regulatory affairs, John E Lincoln, Verification vs. Validation - Product Process Software and QMS About 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. www.globalcompliancepanel.com All rights are reserved © GlobalCompliancePanel. Day One ( 9 AM to 6 PM) Day Two ( 9 AM to 6 PM) 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 Course Outline: John E Lincoln Consultant, Medical device and Regulatory affairs, 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 Overview: 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. This course's aim is to prove "Product Risk Based V&V" by sufficient, 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. 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; 1. Learning Objectives 2. Participation certificates 3. Interactive sessions with the US expert 4. Post event email assistance to your queries. 5. Special price on future purchase of web based trainings. 6. Special price on future consulting or expertise services. 7. Special price on future seminars by GlobalCompliancePanel. 8. Seminar Kit – includes presentation handout, ID card, brochure, trainings catalog, notepad and pen. 9. Networking with industry's top notch professionals Who Will Benefit: ? 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 Price for One Delegate pass Price: $1,295.00 Register now and save $200. (Early Bird) Until March 10, Early Bird Price: $1,295.00 From March 11 to March 25, Regular Price: $1,495.00 March 27-28, 2014 | Las Vegas NV **Please note the registration will be closed 2 days (48 Hours) prior to the date of the seminar. Payment Options: ? 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 161 Mission Falls Lane, Suite 216, Fremont, CA 94539, USA ? PO: Please drop an email to support@globalcompliancepanel.com 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 support@globalcompliancepanel.com or call our toll free 1800 447 9407 for the wire transfer information Contact Information: Event Coordinator Toll free: 1800 447 9407 Fax: 302 288 6884 Email: support@globalcompliancepanel.com NetZealous LLC, DBA GlobalCompliancePanel 161 Mission Falls Lane, Suite 216, Fremont, CA 94539, USA Kindly get in touch with us for any help or information. Look forward to meeting you at the seminar Team GlobalCompliancePanel www.globalcompliancepanel.com All rights are reserved © GlobalCompliancePanel. www.globalcompliancepanel.com All rights are reserved © GlobalCompliancePanel. Registration :Form Please use this form to register online, using your American Express, Visa or MasterCard. To get discounts on group attendance, please call us on +1-800-447-9407 Call us on or fax your PO to 302 288 6884+1-800-447-9407 Please pay your check issued from the payee to NetZealous LLC, our parent company, and mail it to NetZealous, 161 Mission Falls Lane, Suite 216, Fremont, CA 94539, USA Please call us at or email us at Please ?ll this form out and include +1-800-447-9407 support@globalcompliancepanel.com attendee and payment details in it and fax it to 302 288 6884 Terms and Conditions Your registration for this seminar is bound by terms and conditions spelt out here. Please call or mail us if you have any clari?cations or doubts on this issue. Cancellations and Substitutions If you wish to cancel your attendance at our seminar, the person who has registered for this seminar has to submit written cancellations through fax or email at least 10 calendar days before the date of commencement of the event. This will entitle her/him to a full refund minus a $150 administration fee. No cancellation request will be accepted or entertained and no refunds will be issued for requests made outside the stipulated period. A request to this effect has to be sent by email or fax more than ten days before the commencement date of the seminar. After receiving this request, we will issue a credit for the amount paid with a deduction of administration fees of $150. This credit note will be transferred to a future GlobalCompliancePanel event, and a credit note will be issued towards this. You are allowed to make substitutions at any time till the start of the event. 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