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GlobalCompliancePanel to organize webinar on “Excel Spreadsheet Validation for FDA 21 CFR Part 11”

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(Free Press Release) Angela Bazigos, the CEO of Touchstone Technologies Silicon Valley, Inc., will be the Speaker at a webinar that GlobalCompliancePanel, a leading regulatory and compliance continuing education training provider, will organize on August 8. The topic of this webinar is, “Excel Spreadsheet Validation for FDA 21 CFR Part 11”.

GlobalCompliancePanel to organize webinar on “Excel Spreadsheet Validation for FDA 21 CFR Part 11”


      

Description:

One irony of Spreadsheet Applications such as MS Excel is that they are frequently used in 21 CFR 11 compliant environments despite the fact that they were not specifically designed for regulated environments. Further, their development is not optimized for 21 CFR 11 compliance.

Yet, the FDA requires that spreadsheets should be compliant, absence of which can result in a Warning Letter. Another requirement is that validation of Excel Spreadsheet Applications is required as part of a 21 CFR 11 compliant environment.

How do manufacturers resolve this situation? This is what this session is all about. It will help participants understand ways by which they can ensure 21 CFR Part 11 compliance for Excel spreadsheets.

This webinar will cover the following sessions:

o Requirements for Excel Spreadsheets

o FDA Part 11 Validation Guidance

o Compliance Problems with Spreadsheets

o Design Specifications for 21 CFR 11 compliance

o How does the FDA Design and Use spreadsheets

o Documentation for Part 11

o Future Trends in 21 CFR 11 compliance for Excel Spreadsheets

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When: August 8, 10:00 AM PDT | 01:00 PM EDT

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By whom:

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 conducts 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.

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.

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For whom:

The webinar will benefit

o Quality Managers

o Quality Engineers

o Small business owners

o Internal and external auditors

o Management Reps

o FDA inspectors

o Consultants

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Duration: 90 minutes

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To enroll for this webinar, contact

This e-mail address is being protected from spambots. You need JavaScript enabled to view it

Ph: 800-447-9407

Fax: 302-288-6884

For More Details: http://bit.ly/1bg0F8L

 




GlobalCompliancePanel to organize webinar on “Excel Spreadsheet Validation for FDA 21 CFR Part 11”

Source: Press Release

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