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Overview: The Problem: 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. More importantly, CSV is a foundation to other discovery, development & commercialization of products and CSV failure includes failure of those efforts. In this Seminar attendees will learn: This Hands-On course will provide the attendees with both a strategic and a tactical understanding of how CSV fits into all aspects of the Life Sciences Industry and how to implement CSV to ensure successful inspections. It will address the following topics: 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? How to implement CSV How Cloud, Patient Confidentiality are impacted CSV & Business Continuity How to have a successful FDA inspection 483s & Warning Letters and how to respond to CSV related citations Course Outline: Day 1 – Agenda 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 requirements Day 2 – Agenda 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 Lecture 8: 483s & Warning Letters What are 483s & Warning Letters (and other Regulatory Citations) How to Respond to CSV related citations following an inspection Who Should Attend? - 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 Industries: Pharmaceuticals Biotech Medical Device Radiological Health Blood Products Companion Animals Food Cosmetics Tobacco Academia ABOUT SPEAKER – Angela Bazigos CEO, Touchstone Technologies Silicon Valley 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. She teaches classes on Compliance, 21 CFR 11, Computer Systems Validation, and Project Management both to investor groups and industry. Location1: Chicago IL 06th & 07th, February 2014 9:00 AM- 6:00PM EST Venue: WILL BE ANNOUNCED SOON Price: $1,295.00 Discount: Register now and save $200. (Early Bird) Until January 20, Early Bird Price: $1,295.00 from January 21 to February04, Regular Price: $1,495.00 Location2: Los Angeles CA 20th & 21st March 2014 9:00 AM- 6:00PM PDT Venue: WILL BE ANNOUNCED SOON Price: $1,295.00 Discount: Register now and save $200. (Early Bird) Until February25, Early Bird Price: $1,295.00 from February26 to March18, Regular Price: $1,495.00 Contact Information: Event Coordinator Phone: 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 Event Link: http://bit.ly/JXfNv2 NetZealous LLC, DBA GlobalCompliancePanel, 161 Mission Falls Lane, Suite 216, Fremont, CA 94539, USA Phone: 1800 447 9407
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Computer System Validation, US Conferences, US Seminars, Software Validation, 21 CFR 11, FDA Training, HIPAA Training, FDA inspection, Regulatory Tra,
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