OVERVIEW: SPREADSHEET APPLICATIONS SUCH AS MS EXCE 2012 - 21 CFR Part 11 Compliance for Excel Spreadsheets

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OVERVIEW: SPREADSHEET APPLICATIONS SUCH AS MS EXCE 2012 - 21 CFR Part 11 Compliance for Excel Spreadsheets - Webinar By GlobalCompliancePanel

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Category Online Traning,21 CFR 11,FDA Part 11,Excel Spreadsheets

Deadline: October 02, 2012 | Date: October 02, 2012

Venue/Country: Wilmington, U.S.A

Updated: 2012-09-10 15:11:05 (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 experience in the Lifescience industry spanning Project Management, Quality Assurance and Regulatory Affairs and has a patent 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 consults to many Pharma / Biotech / Medical Device and CRO’s 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. 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. Angela Bazigos has been accepted into the prestigious ranks of Stanford Who's Who as a result of her remarkable work in the biotechnology industry. Throughout her brilliant professional career, Angela has routinely exhibited the passion, vision and dedication necessary to be successful in the business world.

Webinar By GlobalCompliancePanel

Price List:

Live : $245.00

Corporate live : $495.00

Recorded : $295.00

Phone: 800-447-9407

Fax: 302-288-6884

webinarsglobalcompliancepanel.com

http://www.globalcompliancepanel.com

1000 N West Street | Suite 1200 | Wilmington | DE | USA | 19801

Event Link - http://bit.ly/RBZLDg

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