Project Management for Computer Systems Validation

Why Should You Attend:

Per the CDRH, 20% of product recalls in the medical device industry are due to faulty software!!! Yet, these human, financial and reputation capital expensive issues, can be averted with computerized systems validation and 21 CFR 11 compliance. The Project Manager for a Validated Computerized System, has to deliver on time and on budget, but with the added risk of having to meet regulatory compliance, often causing project overruns, regulatory findings and missed times to market.

This 2-hr training session will explain the basic tenets of project management, the basic tenets of 21 CFR 11 compliance for Computer Systems Validation and will show how to marry the two, to deliver on time and on budget while meeting regulatory compliance requirements.

Areas Covered in the Webinar:

• Basics of Project Management
• Basics of Computer Systems Validation
• Project Planning for a Computer Systems Validation Project
• Common Pitfalls and How to Avoid them
• What is FDA's most current thinking related to computers and electronic records?
• What are the inspection trends?
• What are most frequent recent citations for Part11?
• What are the most frequent deviations for computer system validation?
• How important is risk based Part11 compliance?

Who Will Benefit:

• Project Managers
• IT Management
• Business Process Owners
• Quality Managers
• Quality Engineers
• GxP
• Consultants
• Pharmaceutical Compliance Officers
• Biotech Professionals
• Medical Device Professionals
• Anyone involved with the FDA

Angela Bazigos
CEO, Touchstone Technologies Inc

Angela Bazigos is the CEO of Touchstone Technologies Inc. She has 40 years of experience in the Life Sciences & Healthcare Industries. Experience combines Quality Assurance, Regulatory Compliance, Information Technology, Project Management, Clinical Lab Science, Microbiology, Food Safety and Turnarounds. Past employers / clients include Roche, Novartis, Genentech & PriceWaterhouseCoopers, Public Health Service. Positions include:

• Chief Compliance Officer, http://morflearning.com/angelabazigos/.
• QA Director, Director of MIS. Co-authored & prototyped 21 CFR 11 guidance with FDA.
• Co-authored Computerized Systems in Clinical Research w/ FDA http://www1.diahome.org/~/media/4FA562336EBD46C58CDC43A8B7773095.ashx.
• Patent on speeding up software compliance https://www.google.com/patents/US8266578.
• Recently quoted in Wall Street Journal for using training to bring regulatory compliance to the Boardroom http://blogs.wsj.com/riskandcompliance/2015/07/24/using-training-to-bring-compliance-to-boardrooms/.
• 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 LifeSciences: http://www.stanfordwhoswho.com/Angela.Bazigos.7144112.html#overview.

Topic Background:

Project Management is defined as the planning and organization of an organization's resources in order to move a specific task, event or duty toward completion. However, Validation of Computerized Systems has a very specific set of tasks that are often mismanaged, resulting in missed deadlines, increased costs, and regulatory risk, and missed times to market for a company’s product.

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