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Summary: GlobalCompliancePanel to hold RAPS approved, two-day, in-person seminar in Las Vegas, NV on the topic, “Verification vs. Validation –Product, Process, Software and QMS” on March 27 and 28, 2014 (Thursday & Friday). John E. Lincoln, Medical Device and Regulatory Affairs consultant will be the speaker at this two-day session. This course has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion. 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, 89109-4313. The seminar will be on March 27 and 28, from 9 A.M to 6 P.M. 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. Mr. Lincoln will also evaluate the following: a) different field-tested, U.S. FDA-reviewed V&V protocols, and b) 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. This session will review a matrix that simplifies “as-product”, “in-product”, process and equipment et al and software VT&V, to assure key FDA requirements are not overlooked. 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. This seminar will help participants: a. Understand Verification and Validation, differences and how they work together; b. Discuss recent regulatory expectations; c. Know how to document a "risk-based" rationale, and use it in a resource-constrained environment; d. Determine key "milestones" and "tasks" in a project; e. Locate and document key subject "inputs"; f. Compile "generic" Master and Individual Validation Plans; g. Learn the key element of a Product V&V File/Protocol; h. Understand how to develop Process and/or Production/Test Equipment V&V Files/Protocols; i. Get a grasp of basic Test Case construction; j. Understand sample sizes and their justification; k. Learn the key elements of Software V&V expected by the FDA and how to document; l. Deal with hardware and software vendors, sales and marketing m. Consider a field-tested software V&V documentation "model"; n. See how to compile QMS Electronic Records and Electronic Signatures V&Vs to satisfy 21 CFR Part 11. 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. Agenda 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: a. Senior and middle management and staff b. Regulatory Affairs c. Quality Assurance or Quality Control Professionals d. QA/QC e. IT/IS f. R&D g. Production Management h. Manufacturing Engineers i. Process Engineers j. Software Engineers k. Project Managers l. Hardware and software vendors, sales and marketing m. 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: Register now and save $200. (Early Bird) Until January 15, Early Bird Price: $1,295.00. From January 16 to March 25: Regular Price: $1,495.00 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 that 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 GlobalCompliancePanel NetZealous LLC, 161 Mission Falls Lane Suite 216, Fremont CA 94539
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