2-day In-person Seminar Ticket
Sale Date Ended
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. 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, 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.
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:
Day 1 – Agenda
Lecture 1: Introduction / Background
Lecture 2: CSV at a High Level
Lecture 3: CSV Detailed Study
Lecture 4: CSV Detailed Study (Cont'd)
Day 2 – Agenda
Lecture 5: CSV Detailed Study (Cont'd)
Lecture 6: Special Topics
Lecture 7: Project Management for CSV
Lecture 4: Quality Assurance for CSV
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.
DATE, VENUE & PRICE:
Location: Mumbai| June 5th and 6th 2014| 9 AM to 6 PM
Venue: The LaLiT Mumbai
Venue Address: Sahar Airport Road, Andheri East, Mumbai - 400059
In Rupees:INR 18,000
In Dollars: $ 300
Register now and save 2000 (Early Bird)
Until May 15, Early Bird Price: INR 18,000
From May16 to June 03, Regular Price: INR 20,000
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