1. Latest News
  2. Submit Press Release

Live webinar Excel Spreadsheet Compliance with 21 CFR 11 byAngela Bazigos

This course will describe the regulatory and business requirements for Excel spreadsheets, using examples from FDA recommendations. It will then cover the design and installation of those Excel Spreadsheets, to ensure the integrity of the data,

Aug. 31, 2011 - PRLog -- Why should you 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 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 environments.

Areas Covered in the Session

1. Requirements for Excel Spreadsheets
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

Who will Benefit

•   Quality Managers
•   Quality Engineers
•   Small business owners
•   Internal and external auditors
•   Management Reps
•   FDA inspectors
•   Consultants
About Speaker
Angela Bazigos is the CEO of Touchstone Technologies Silicon Valley, Inc. an FDA Compliance company. She has almost 30 years experience in the Life sciences industry and has applied for patents aimed at speeding up Software Compliance. She is a member of the SQA CVIC (Society of Quality Assurance Computer Validation Initiative Committee), DIA and RAPS and teaches classes on 21 CFR 11, Computer Systems Validation, Compliance Strategy and Project Management. More recently, Ms. Bazigos was selected to co-author Computerized Systems In Clinical Research / Current Data Quality and Data Integrity Concepts with FDA, DIA and Academia

Price List: Live : $189.00 Corporate live : $499.00 Recorded : $249.00, CD:$299.00

For any assistance contact us at support@compliance2go.com or call us at 877.782.4696


--- End ---

Click to Share

Contact Email:
***@compliance2go.com Email Verified
Location:Houston - Texas - United States
Tags:Compliance Training, Conference, E-learning, Education, Event, Fda, Web Seminar, Webinar, Compliance2go, Medical Device
Verified Account Email Address

Disclaimer:   Issuers of the press releases are solely responsible for the content of their press releases. PRLog can't be held liable for the content posted by others.   Report Abuse

Latest Press Releases By “


Trending News...

Like PRLog?
Click to Share