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Validity : 20th Apr'24 to 30th Apr'24
Project Management for Computer Systems Validation
- Basics of Project Management
- Basics of Computer Systems Validation
- Project Planning for a Computer Systems Validation Project
- Common Pitfalls and How to Avoid them
Overview of the webinar
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.
Who should attend?
- 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
Why should you attend?
Per the CDRH, 20% of product recalls in the medical device industry are due to faulty software!!! Yet, these humans, 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 the 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.
Faculty - Mz.Angela Bazigos
Angela Bazigos, is the CEO of Touchstone Technologies, Inc. She has 40 years of experience working in hospitals and Pharma industry. Her background includes companies like Roche, Novartis, Genentech and PricewaterhouseCoopers in GLP, GCP, GMP, Medical Device and Data Integrity Roles. She has held positions such as Chief Compliance Officer, QA Director and has acted on behalf CEO for communications with FDA.
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 Life Science Investment Groups as well as to Pharma / Biotech / Medical Device companies on compliance matters, including strategy, submissions, quality assurance and remediation following action by the FDA. Has contributed to prototyping of 21 CFR 11 & CSV before promulgation to industry.
Ms. Bazigos co-authored Computerized Systems in Clinical Research / Current Data Quality and Data Integrity Concepts with FDA, DIA and Academia. She holds a patent in speeding up software validation. She has been 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 contributions to the Life Sciences industry.