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Summary: GlobalCompliancePanel will organize a RAPS-preapproved two-day, in-person seminar in Chicago, IL on the topic, “Computer System Validation –Reduce Costs and Avoid 483s” on February 6 and 7, 2014 (Thursday & Friday). Angela Bazigos, CEO of Touchstone Technologies Silicon Valley, Inc. will be the speaker at this two-day session. The course, “Computer System Validation –Reduce Costs and Avoid 483s “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 Courtyard Chicago Downtown/River North 30 East Hubbard Chicago, Illinois 60611. (Ph: 312-329-2500) The seminar will be on February 6 and 7, 2014, from 9 AM to 6 PM EST. What the seminar is about: This seminar is about what those in the medical devices industry can do to avoid 483’s/Warning Letters from the FDA. Computer Systems Validation (CSV), also known as Software Validation, is a prime element of the Life Sciences Industry. It is a requirement of all the predicate rules, as well as 21 CFR 11 and Annex 11. The latter impact all areas of ICH Q9 and ICH Q10. However, it is often very hard to detect the requirement for CSV, and very hard to determine what needs to be done, to meet domestic and/or international regulations or business continuity requirements, if one does not know how to implement CSV. On top of this, to add to the already complicated scenario, the FDA has stepped up 21 CFR 11 inspections that include CSV. As a result, the number of 483s/Warning Letters due to CSV continues to be on the rise. It is estimated that 20 percent of all Medical Device Recalls are due to incorrect CSV. Currently, there are many outstanding Official Actions by Regulatory Authorities (e.g. 483s, Warning Letters, etc.) that include citations for CSV. This is expected to further escalate as technology advances and companies need to consider Cloud Technologies and, as well as in view of patient privacy issues such as HIPAA Not understanding CSV can lead to enormous costs: One incorrect implementation of CSV in 2013 resulted in fines of up to a whopping $3 billion. There are several bottlenecks associated with noncompliant CSV: Software Projects requiring CSV often overrun by several months, and corrections to a CSV 483 can result in costs of $250,000 and often multiple issues are found. More importantly, CSV is the pathway to other discovery, development and commercialization of products, and so, CSV failure can lead to failure of those efforts, as well. This seminar will be a valuable tool in helping professionals understand the ways by which they can ensure CSV and prevent About the Speaker: Angela Bazigos is the CEO of Touchstone Technologies Silicon Valley, Inc. an FDA Compliance company. She has almost 30 years’ experience in the Life Sciences industry and has applied for patents aimed at speeding up Software Compliance. She is a member of the SQA CVIC (Society of Quality Assurance Computer Validation Initiative Committee), DIA and RAPS and conducts classes on 21 CFR 11, Computer Systems Validation, Compliance Strategy and Project Management. More recently, Ms. Bazigos was selected to co-author Computerized Systems in Clinical Research/Current Data Quality and Data Integrity Concepts with FDA, DIA and Academia. Angela Bazigos has been accepted into the prestigious ranks of Stanford Who's Who as a result of her remarkable work in the biotechnology industry. Throughout her brilliant professional career, Angela has routinely exhibited the passion, vision and dedication necessary to be successful in the business world. The agenda: The seminar will have the following agenda: Course Description: Day 1 Lecture 1: Introduction/Background o Introductions/Participants' Understanding/Participants' Objectives for the Course (Please come prepared to discuss) o Overview of Life Sciences Lifecycle (ICH Q10) and how CSV fits into it o Detecting CSV in predicate rules/guidances o CSV in 21 CFR 11/Annex 11 o The FDA’s 21 CFR 11 Add-On Inspections Lecture 2: CSV at a High Level o CSV: It's Easy!! Really!! o CSV components and deliverables o CSV & ICH Q9 (Risk Assessment) Lecture 3: CSV Detailed Study o Validation Plan o Requirements Specifications o Functional Specifications o Exercise on how to create requirements Day 2 Lecture 4: CSV Detailed Study (Cont'd) o Design Specifications o Software Configuration and Build o Traceability Matrix o Verification and Testing o Validation Report o Validation Registry o CSV for Excel and other spreadsheets Lecture 5: CSV implementation in Cloud o Regulatory Compliance for the Cloud Lecture 6: Business Continuity o Implementing Business Continuity for CSV Lecture 7: Project Management & QA o Project Management for CSV o How to audit CSV projects Lecture 8: 483s & Warning Letters o What are 483s & Warning Letters (and other Regulatory Citations) o How to Respond to CSV related citations following an inspection For whom: This seminar will benefit: o VP of IT o Director of IT o Quality Managers o Project Managers (for CSV/IT) o Validation Specialists o Database Administrators o System Administrators o Directors/Senior Directors of Discovery o Directors/Senior Directors of Development o Directors/Senior Directors of Commercialization o Document Managers o Training Managers It will be of use in the following industries: o Pharmaceuticals o Biotech o Medical Device o Radiological Health o Blood Products o Companion Animals o Food o Cosmetics o Tobacco o Academia 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 20: Early Bird Price: $1,295.00 From January 21 to February 4: 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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