Risk Based Approach to 21 CFR 11 ER/ES & Validation of Computer Systems

01:00 PM EDT | 10:00 AM PDT | 12:00 PM CDT Duration 90 Minutes

Webinar Includes : All the training handouts , Certificate by the Speaker ,Q/A and 90 Mins Live Webinar

"Hear By Angela Bazigos who recently quoted in Wall Street Journal for using training to bring regulatory compliance to the Boardroom"

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:

Description

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.

Areas Covered

1. What is 21 CFR 11 and Computer Systems Validation

2. The FDA’s perspective (also, other regulatory agencies)

3. How to implement 21 CFR 11 and Computer Systems Validation

4. Special Topics: Excel, Cloud and Business Continuity

5. Project Management for 21 CFR 11

6. Quality Assurance for 21 CFR 11

7. 483s and Warning Letters for Computer Systems Validation and how to Respond to them

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

Industries who can attend

This 90-minute online course is intended for professionals in the Medical Device, Biotechnology,Pharmaceutical Industry. Although not presently stated in the draft , the same guide could be used by FDA Regulated Industries personnel


Speaker Profile

Angela Bazigos

Angela Bazigos.CEO of Touchstone Technologies Inc. She has 40 years of experience in the Life Sciences & Healthcare Industries. Experience combines Quality Assurance, Regulatory Compliance, Business Administration, Information Technology, Project Management, Clinical Lab Science, Microbiology, Food Safety, Turnarounds and Business Development. Past employers / clients include Roche, Novartis, Genentech & PriceWaterhouseCoopers. Positions include Chief Compliance Officer at Morf Media. Co-authored & prototyped 21 CFR 11 guidance with FDA.  Co-authored Computerized Systems in Clinical Research w/ FDA. Patent on speeding up software compliance. Recently quoted in Wall Street Journal for using training to bring regulatory compliance to the Boardroom. National Trainer for Society of Quality Assurance. Comments / collaborates with FDA on new guidance documents. Former President of Pacific Regional Chapter of Society of Quality Assurance. Stanford’s Who’s Who for Life Sciences.

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