Expert Profile
Angela Bazigos
CEO of Touchstone Technologies Silicon Valley, Inc,
Angela Bazigos is an Angel Investor and the CEO of Touchstone Technologies Silicon Valley, Inc. “Your Passport to Compliance”. She has 30 years’ experience in the Life Science industry spanning Project Management, Quality Assurance and Regulatory Affairs and has a patent aimed at speeding up Software Compliance.
Ms Bazigos is a member of the SQA CVIC (Society of Quality Assurance Computer Validation Initiative Committee), ASQ, DIA and RAPS and consults to investment groups on Life Sciences investments as well as Pharma / Biotech / Medical Device companies 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 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.
Ms Bazigos is a member of the SQA CVIC (Society of Quality Assurance Computer Validation Initiative Committee), ASQ, DIA and RAPS and consults to investment groups on Life Sciences investments as well as Pharma / Biotech / Medical Device companies 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 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.
Live Training by Angela Bazigos
Software is widely used in our industry and selection of new software or upgrade of existing software is one of the activities that crop up every year in an IT department’s task list. Our industry, has the added challenge of being subject to both regulations that add another degree of complexity to this already complex task.
Live Session
Thursday,
May 23, 2013
10:00 AM PDT | 01:00 PM EDT ,
Duration:120
Recorded Training by Angela Bazigos
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.
Recorded Session Access recorded sessions for multiple participants unlimited viewing for 6 months.
Cloud computing has become perhaps the hottest compliance topic related to computer validation and electronic records. The potential economic and resource advantages to using cloud based environments guarantees that management will expect that compliance strategies will be developed that will support decisions to utilize cloud environments to perform regulated activities.
Recorded Session Access recorded sessions for multiple participants unlimited viewing for 6 months.
Regulatory Inspections are performed by various agencies to assure that anyone involved in the lifecycle of a pharmaceutical / biotech / medical device product, abides by the laws and regulations. This affects the entire supply chain.
Recorded Session Access recorded sessions for multiple participants unlimited viewing for 6 months.
In Dec. 2010, the FDA has stepped up enforcement for 21 CFR 11 compliance with spreadsheets being considered as low hanging fruit for FDA inspectional findings.
Recorded Session Access recorded sessions for multiple participants unlimited viewing for 6 months.
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