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Overview: Computer Systems Validation (CSV) also known as Software Validation is all-pervasive in 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, unless one knows how to implement CSV, 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. In addition, the FDA has stepped up 21 CFR 11 inspections that include CSV. Consequently, the number of 483s / Warning Letters due to CSV continue to be on the rise. It is estimated that 1 in 5 of 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 patient privacy issues such as HIPAA Costs of not understanding CSV are enormous: One 2013 incorrect implementation of CSV resulted in fines of up to $3Billion. Software Projects requiring CSV often overrun by several months. Corrections to a CSV 483 can result in costs of $250,000 and often multiple issues are found. In this Seminar attendees will Learn: 1. CSV in the Life Sciences Industry: What it is, where to find requirements in other guidances including 21 CFR 11 & Annex 11, how it fits in with ICH Q9 and ICH Q10 2. How to implement CSV 3. How Cloud, , Patient Confidentiality are impacted 4. CSV & Business Continuity 5. How to have a successful FDA inspection 6. 483s & Warning Letters and how to respond to CSV related citation Industries: • Pharmaceuticals • Biotech • Medical Device • Radiological Health • Blood Products • Companion Animals • Food • Cosmetics Course Outline: Day One; Lecture 1: Introduction / Background • Introductions / Participants' Understanding / Participants' Objectives for the Course (Please come prepared to discuss) • Overview of Life Sciences Lifecycle (ICH Q10) and how CSV fits into it • Detecting CSV in predicate rules / guidances • CSV in 21 CFR 11 / Annex 11 • The FDA,s 21 CFR 11 Add-On Inspections ________________________________________ Lecture 2: CSV at a High Level • CSV: It's Easy!! Really!! • CSV components and deliverables • CSV & ICH Q9 (Risk Assessment) ________________________________________ Lecture 3: CSV Detailed Study • Validation Plan • Requirements Specifications • Functional Specifications • Exercise on how to create requirement. Day Two Lecture 4: CSV Detailed Study (Cont'd) • Design Specifications • Software Configuration and Build • Traceability Matrix • Verification and Testing • Validation Report • Validation Registry • CSV for Excel and other spreadsheets ________________________________________ Lecture 5: CSV implementation in Cloud • Regulatory Compliance for the Cloud ________________________________________ Lecture 6: Business Continuity • Implementing Business Continuity for CSV ________________________________________ Lecture 7: Project Management & QA • Project Management for CSV • How to audit CSV projects Who Will Benefit: • VP of IT • Director of IT • Quality Managers • Project Managers (for CSV / IT) • Validation Specialists • Database Administrators • System Administrators • Directors / Senior Directors of Discovery • Directors / Senior Directors of Development • Directors / Senior Directors of Commercialization • Document Managers • Training Managers About Speaker – Angela Bazigos, is the CEO of Touchstone Technologies Silicon Valley, Inc. "Your Passport to Compliance". She has 30 years of experience in the Lifesciences industry spanning Project Management, Quality Assurance and Regulatory Affairs and has a patent aimed at speeding up Software Compliance. Ms Bazigos is a member of the SQA CVIC (Society of Quality Assurance Computer Validation Initiative Committee), ASQ, DIA and RAPS and consults to investment groups on Lifesciences investments as well as Pharma / Biotech / Medical Device companies on compliance matters, including strategy, submissions, quality assurance and remediations following action by the FDA. Date, Venue & Price: Location : Chicago IL 6th & 7th February 2014 9 AM to 6 PM EST Venue: Courtyard Chicago Downtown/River North Price: $1,295.00 Register now and save $200. (Early Bird) Until January 20, Early Bird Price: $1,295.00 From January 21 to February 04, Regular Price: $1,495.00 Address: 30 East Hubbard Chicago, Illinois 60611 USA Location : Los Angeles CA 20th & 21st March 2014 9 AM to 6 PM PDT Venue: DoubleTree by Hilton Hotel Los Angeles Downtown Price: $1,295.00 Register now and save $200. (Early Bird) Until February 25, Early Bird Price: $1,295.00 From February 26 to March 18, Regular Price: $1,495.00 Address: 120 South Los Angeles Street, Los Angeles, California, 90012, USA Contact Information: Event Coordinator Toll free: 1800 447 9407 Fax: 302 288 6884 Email: support@globalcompliancepanel.com Website: https://www.globalcompliancepanel.com Event Link - http://bit.ly/L8O0ZA LIVE CHAT SUPPORT - http://www.globalcompliancepanel.com/chat/client.php GlobalCompliancePanel NetZealous LLC 161 Mission Falls Lane, Suite 216, Fremont, CA 94539, USA.
Related Articles -
Computer Systems Validation, 21 CFR 11, ICH Q9 and ICH Q10, US Conferences, US Seminars, FDA Training, Verification vs. Validation, CSV 483,
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