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.
Phone: 800-447-9407 email@example.com 2-day In-person Seminar on Verification vs. Validation - Product, Process, Software and QMS Location: Las Vegas | January 17th & 18th, 2013 | 9 AM to 6 PM EST Register Now Course "Verification vs. Validation - Product, By John E. Lincoln Process, Software and QMS" has been pre-approved Price: $1,295.00 (for 1 attendee) by RAPS as eligible for up to 12 credits towards a Register now and save $200. (Early Bird) participant's RAC recertification upon full completion. Course Outline: Day 1: John E Lincoln Lecture 1: Master Validation Planning and the Master Validation Consultant, Medical device Plan(s) and Regulatory Lecture 2: Product, Process / Equipment Hardware V&V affairs, Lecture 3: Product / Device V&V Lecture 4: TSoftware V&V Lecture 5: Quality Management System / 21 CFR Part 11 V&V John E. Lincoln is Principal of J. Lecture 8:Summary of morning discussion E. Lincoln and Associates LLC, a consulting company. John, a Lecture 7: Group activity on the MVPs graduate of UCLA, is a medical Lecture 8: Review of group activity and Q&A device and Regulatory Affairs consultant. He has helped Course Outline: Day 2: companies to implement or modify their GMP systems and Lecture 9: Software V&V documentation "model" procedures, product risk management and U.S. FDA Lecture 10: Software V&V protocols - "black box", "white box" responses. In addition, he has Lecture 11: Electronic Records and Electronic Signatures (Part 11) successfully designed, written and run all types of process, equipment and software Lecture 12: Summary of morning discussion qualifications/validations, which Lecture 13:Group activity on 1) hardware / equipment, and 2) have passed FDA audit or submission scrutiny, and have software V&V protocols been described in peer-reviewed Lecture 14:Review of group activity and Q&A technical articles and workshops worldwide. 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. Who Will Benefit: l Senior and middle management and staff l Regulatory Affairs l Quality Assurance or Quality Control Professionals venue WILL BE ANNOUNCED SOON l QA/QC l IT/IS l R&D Register Now l Production Management l Manufacturing Engineers l Process Engineers l Software Engineers l Project Managers l Hardware and software vendors, sales and marketing l Any professional tasked with V&V responsibilities It would be really nice if you can circulate this mail to all your deserving colleagues who can immensely benefit from this program. For more information, please contact the event coordinator. We look forward to seeing you at the webinar. Best regards, Event-coordinator GlobalCompliancePanel About GlobalCompliancePanel GlobalCompliancePanel is an online knowledge fulfillment community portal & it has put together a new model for online compliance training by creating a single window of learning opportunities for compliance professionals & providing a forum for expert speakers/panelists to render their services through simplified online training delivery mechanisms. Our commitment is give compliance regulatory training, showcasing of best industry practices & quality enrichment training sessions in a most cost effective manner. Compliance professionals can benefit from a wide range of training sessions, giving a diverse choice of events & all sessions being either Live or recorded stream or in the form of audio CDs. GlobalCompliancePanel portal ensures a secure & cost effective online environment and also support your E-learning and development on/through our website. Keep track of all webinars arranged for your industry through notifications & event calendars being mailed to your inbox. GlobalCompliancePanel opens new doors of learning opportunities for professionals. GlobalCompliancePanel www.globalcompliancepanel.com Livermore Common, Fremont, CA 94539, USA Phone: 800-447-9407 or Fax your PO to: 302-288-6884 If you do not wish to receive this training alerts from GlobalCompliancePanel Click Unsubscribe
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