21 CFR 11 Compliance for Excel Spreadsheets

Live Webinar

  • 90 minutes

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. FDA continues to enforce Part 11 through its new Part 11 inspection and enforcement program. Just in the last 3 years, FDA issued more than 30 warning letters with Part 11 violations.

Join this session by expert speaker Angela Bazigos, where she will outline the FDA requirements for Excel spreadsheets used in regulated environments and provide guidance on 21 CFR Part 11 validation.

Session Highlights:

  • Requirements for Excel Spreadsheets

  • FDA Part 11 Validation Guidance

  • Compliance Problems with Spreadsheets

  • Design Specifications for 21 CFR 11 compliance

  • Documentation for Part 11

  • Future Trends in 21 CFR 11 compliance for Excel Spreadsheets

Why You Should Attend:

Spreadsheet Applications such as MS Excel are frequently used in 21 CFR 11 compliant environments, but they were not specifically designed for regulated environments and their development is not optimized for 21 CFR 11 compliance. However, the FDA expects that spreadsheets are compliant and lack of compliance can result in a warning letter.

Who Should Attend:

  • Regulatory VP

  • Quality VPs

  • IT VPs

  • Regulators

  • Regulatory Affairs professionals: Quality Managers, Quality Engineers, Small business

  • Owners, GxP Consultants

  • Pharma, Biotech, Medical Device, Anyone involved with FDA

*You may ask your Question directly to our expert during the Q&A session.

** You can buy On-Demand and view it as per your convenience.

Angela Bazigos

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.

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