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. 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.

1. Contact Us : +1-416-915-4458
We Empower, You Comply!
21 CFR 11 Compliance for Excel Spreadsheets
Thursday, April 11, 2013 10:00 AM PDT | 01:00 PM EDT
Duration : 90 Minutes Speaker | Angela Bazigos
To register for this webinar please visit our website www.compliancetrainings.com
Webiar Description:
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.
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.
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
To register for this webinar please visit our website www.compliancetrainings.com

2. Speaker Profile:
Angela Bazigos is the CEO of Touchstone Technologies Silicon Valley and has
almost 30 years experience in life science. She has received a patent for speeding
up software compliance and has applied for patents aimed at speeding up
software compliance and FDA software audits. She has co-authored
“Computerized Systems in Clinical Research” with the FDA, DIA and Academia and
teaches classes in project management, computer systems validation, quality
assurance and IT. She is the Vice President of the Pacific
Regional Chapter of Society of Quality Assurance and writes articles for the SQA journal. She is also a
member of DIA, RAPS and CVIC. She was recently inducted into Stanford’s Who’s Who for contributions to
the Life Sciences industry.