Project Management For Computer Systems Validation
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.
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.
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.
Webinar Includes:
Q/A Session with the Expert to ask your question
PDF print only copy of PowerPoint slides
90 Minutes Live Presentation
Areas Covered in the Session
- FDA Inspections - background
- Causes of Form 483 / Warning Letter
- Some recent results of companies failing to respond appropriately
- Best Practices for Responding to 483
- Best Practices for Responding to Warning Letter
- What to do if the responses fail
Who will benefit: (Titles)
Project Managers
IT Management
Business Process Owners
Quality Managers
Quality Engineers
GxP
Consultants
About Speaker
Angela Bazigos is the CEO of Touchstone Technologies Silicon Valley, Inc. “Your Passport to Compliance”. She has 30 years experience in the Lifescience industry spanning Project Management, Quality Assurance and Regulatory Affairs and has a patent aimed at speeding up Software Compliance. She is a member of the SQA CVIC (Society of Quality Assurance Computer Validation Initiative Committee), DIA and RAPS and consults to many Pharma / Biotech / Medical Device and CRO’s on compliance matters, including strategy, submissions, quality assurance and remediations following action by the FDA. She teaches classes on Compliance, 21 CFR 11, Computer Systems Validation, and Project Management. 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 Lifescience industry.