SPREADSHEET APPLICATIONS SUCH AS MS EXCEL ARE FREQ 2013 - 21 CFR Part 11 Compliance for Excel Spreadsheets

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SPREADSHEET APPLICATIONS SUCH AS MS EXCEL ARE FREQ 2013 - 21 CFR Part 11 Compliance for Excel Spreadsheets - Webinar By GlobalCompliancePanel

Website http://alturl.com/fqott | Edit Freely

Category Webinar, Health, Pharma, Medical Device, FDA, Clinical

Deadline: May 16, 2013 | Date: May 16, 2013

Venue/Country: California, U.S.A

Updated: 2013-05-09 14:01:35 (GMT+9)

Call For Papers - CFP

Overview: 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

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.

NetZealous LLC,

DBA GlobalCompliancePanel

161 Mission Falls Lane,

Suite 216, Fremont, CA 94539, USA

USA Phone:800-447-9407

Fax: 302-288-6884

webinarsglobalcompliancepanel.com

http://www.globalcompliancepanel.com

Event Link - http://alturl.com/9no9s

Keywords: Accepted papers list. Acceptance Rate. EI Compendex. Engineering Index. ISTP index. ISI index. Impact Factor.
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