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Angela Bazigos



Project Management for Computer Systems Validation

Product Id : IT1058       Category : Information Technology

90 Minutes

Description :

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. 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 detailed webinar 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 in a more effective manner.
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Areas Covered in the Session :
  • Basics of Project Management
  • 21 CFR 11 and Computer Systems Validation (CSV)
  • Project Planning for a Computer Systems Validation Project
  • CSV Deliverables
  • Hiddent CSV Deliverables
  • Metrics & Gantt Charts
  • Common Pitfalls and How to Avoid them
  • The 10 Deadly Sins!!
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Who Will Benefit:
  • Project Managers
  • IT Management
  • Business Process Owners
  • Quality Managers
  • Quality Engineers
  • GxP
  • Consultants
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For Live – How it works:
  • Login Information with Password to join the session, 24 hours prior to the webinar
  • Presentation Handout in .pdf format
  • Presentation from the Speaker
  • Q&A session with the Speaker
  • Feedback form
  • Certificate of Attendance
For Recording – What you will receive:
  • Login Information with Password to view the webinar, 24 hours after the Live webinar (link valid for 6 months)
  • Presentation Handout in .pdf format
  • Recorded session of the presentation from the Speaker
  • Feedback form
  • Certificate of Attendance (optional)
Speaker Profile
Angela Bazigos, is the CEO of Touchstone Technologies Silicon Valley, Inc. "Knowledge is Power". She has 35 years of experience in the Lifesciences industry spanning GLP, GCP, GMP, Medical Devices & 21 CFR 11 and has a patent aimed at speeding up Software Compliance.

Ms. Bazigos is a Past President of PRCSQA, a member of the SQA CVIC, ASQ, DIA and RAPS. She works closely with the FDA on behalf of her clients. She consults to LifeScience Investment Groups as well as to Pharma / Biotech / Medical Device companies on compliance matters, including strategy, submissions, quality assurance and remediations following action by the FDA.

More recently, Ms. Bazigos co-authored Computerized Systems in Clinical Research / Current Data Quality and Data Integrity Concepts with FDA, DIA and Academia. She was on the board for UC Berkeley's Business School for Executive Education in Life Sciences and is now on the Stanford Who's Who Registry for her contributions to the Lifesciences industry.
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