Pricing
2. FDA Part 11 Validation Guidance 3. Compliance Problems with Spreadsheets 4. Design Specifications for 21 CFR 11 compliance 5. How does the FDA Design and Use spreadsheets 6. Documentation for Part 11 7. Future Trends in 21 CFR 11 compliance for Excel Spreadsheets
Live ( Single registration ) : $189.00 Group ( Max 10 Attendee): $249.00 On Demand (Recording available):$289
.About Speaker
Angela Bazigos has been accepted into the prestigious ranks of Stanford Whos Who as a result of her remarkable work in the biotechnology industry. Throughout her brilliant professional career, Angela has routinely exhibited the passion, vision and dedication necessary to be successful in the business world. Angela Bazigos is the CEO of Touchstone Technologies Silicon Valley, Inc. Your Passport to Compliance. She has 30 years experience in the Life Sciences industry spanning project management, Quality Assurance and Regulatory Affairs. She has applied for patents aimed at speeding up Software Compliance and FDA Audits. Angela is a member SQA (Society of Quality Assurance) as well as of the SQA CVIC (Computer Validation Initiative Committee), DIA and RAPS. She provides consulting services to Pharma, Biotech, Medical Device and CRO industries on compliance matters, including strategy, submissions, quality assurance, computer systems validation, and remediations following action by the FDA. She also 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 also on the board for UC Berkeleys Haas Business School for Executive Education in Life Sciences.
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