Project Management for Computer Systems Validation and 21 CFR 11 / Annex 11

Product Id : FDA87
Instructor : Angela Bazigos
Jan 09, 2018 1:00 PM ET | 12:00 PM CT | 10:00 AM PT | 90 Minutes

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Overview:

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.

In this Session speaker explain the Basics of Project Management and Computer Systems Validation, 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.

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 class 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.

Learning Objectives:

  • 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 Owner
  • Quality Managers
  • Quality Engineers
  • GxP
  • Consultants
Speaker Profile:

Angela Bazigos is the CEO of Touchstone Technologies Inc. She has degrees in Microbiology and Computing and 40 years of experience in the Life Sciences, Healthcare & Public Health Services. Experience combines Quality Assurance, Regulatory Compliance, Business Administration, Information Technology, Project Management, Clinical Lab Science, Microbiology, Food Safety & Turnarounds. Past employers / clients include Royal Berkshire Hospital, Roche, Novartis, Genentech, PriceWaterhouseCoopers & Stanford Hospital. Positions include Chief Compliance Officer : http://morflearning.com/angelabazigos/, Director of QA and MIS Director.  Co-authored & prototyped 21 CFR 11 guidance with FDA.  Co-authored Computerized Systems in Clinical Research w/ FDA & DIA:

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/

Includes training 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 LifeSciences: http://www.stanfordwhoswho.com/Angela.Bazigos.7144112.html#overview  


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