2-day In-person Seminar on Validation and 21 CFR Part 11 Compliance of Computer Systems at Mumbai

Event Details

Time: June 5, 2014 at 9am to June 6, 2014 at 6pm
Location: The LaLiT Mumbai
Street: Sahar Airport Road, Andheri East, Mumbai - 400059
City/Town: Mumbai
Website or Map: http://bit.ly/1sodjYi
Phone: 1800 425 9409
Event Type: seminar, pharma, medical, clinical, health, compliance, regulatory, fda
Organized By: GlobalCompliancePanel
Latest Activity: May 9, 2014

Export to Outlook or iCal (.ics)

0 members like this

Event Description

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. 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.

The Seminar:

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: