Project Management for Computer Systems Validation
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This document outlines a webinar led by Angela Bazigos, focusing on project management and compliance with 21 CFR 11 for computerized systems validation in the life sciences industry. The session aims to help participants manage projects within regulatory frameworks effectively, addressing common pitfalls and strategies for success. Bazigos, an experienced professional in the field, highlights the importance of proper validation to avoid costly software-related product recalls.
Project Management for Computer Systems Validation
- 1. Contact Us : +1-416-915-4458 We Empower, You Comply! Webiar Description: Areas Covered in the Session : Who Will Benefit: Speaker Profile: quality assurance and remediations following action by the FDA. She teaches classes on Compliance, 21 CFR 11, Computer Systems Validation, and Project Management both to investor groups and industry. More recently, Ms. Bazigos co-authored Computerized Systems in Clinical Research / Current Data Quality and Data Integrity Concepts with FDA, DIA and Academia. She is on the board for UC Berkeley’s Business School for Executive Education in Life Sciences and on the Stanford Who’s Who Registry for contributions to the Life science industry. 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 2 hours 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. To register for this webinar please visit our website www.compliancetrainings.com Project Management for Computer Systems Validation Angela Bazigos is the CEO of Touchstone Technologies Silicon Valley, Inc. “Your Passport to Compliance”. She has 30 years of experience in the Life sciences industry spanning Project Management, Quality Assurance and Regulatory Affairs and has a patent aimed at speeding up Software Compliance. Ms. Bazigos is the president of PRCSQA (Pacific Regional Chapter of the Society of Quality Assurance) a member of the SQA CVIC (Society of Quality Assurance Computer Validation Initiative Committee), ASQ, DIA and RAPS and consults to Pharma / Biotech / Medical Device companies as well as investment groups on compliance matters, including strategy, submissions, Thursday, November 7, 2013 Duration : 120 Minutes 09:00 AM PDT | 12:00 PM EDT Speaker | Angela Bazigos > 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!! To register for this webinar please visit our website www.compliancetrainings.com > Project Managers > IT Management > Business Process Owners > Quality Managers > Quality Engineers > GxP > Consultants