Medical Device 2013 - 21 CFR 11 Compliance for Excel Spreadsheets

21 CFR 11 Compliance for Excel Spreadsheets
From: $199
Date and Time: Thursday, 26th September, 2013 | 1:00 P.M. to 3:30 P.M. EDT
Duration of the Training: 120 mins
Speaker: Angela Bazigos
Topic:
21 CFR 11 Compliance for Excel Spreadsheets
Background:
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.
Why should you attend/Description of the topic:
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 be compliant and lack of compliance can result in a warning letter. Consequently, validation of Excel Spreadsheet Applications is required as part of a 21 CFR 11 compliant environment.
Level-Adv/Int/Basic: Basic / Intermediate
Areas Covered in the Session:
- 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
Who will benefit:
- Quality Managers
- Quality Engineers
- Small business owners
- GxP
- Consultants
- Quality VPs
- IT VPs
Target Companies:
Pharma e.g. Pfizer, Roche, GSK; Biotech e.g. Genentech; Medical Device e.g. Medtronic, Stryker; CROs e.g. Covance, Quintiles, Theorem etc.
Target Associations:
RAPS, ISPE, SQA, PMI
Target Audience:
Pharma, Biotech, Medical Device, Anyone involved with FDA
Instructor Profile:
Angela Bazigos is the CEO of Touchstone Technologies Silicon Valley, Inc. “Your Passport to Compliance”. She has 30 years of experience in the Lifesciences industry spanning Project Management, Quality Assurance and Regulatory Affairs and has a patent aimed at speeding up Software Compliance.
Ms Bazigos is the president of PRCSQA (Pacific Regional Chapter of the Society of Quality Assurance) a member of the SQA CVIC (Society of Quality Assurance Computer Validation Initiative Committee), ASQ, DIA and RAPS and consults to Pharma / Biotech / Medical Device companies as well as investment groups 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 Lifescience industry.
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