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RAPS pre-approved webinar on “21 CFR Part 11 Compliance for Excel Spreadsheets”

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(Free Press Release) GlobalCompliancePanel, a leading regulatory and compliance continuing education training provider, will organize a RAPS pre-approved webinar on the topic, “21 CFR Part 11 Compliance for Excel Spreadsheets” on October 2. Angela Bazigos, CEO of Touchstone Technologies Silicon Valley, Inc., an FDA Compliance company, will be the speaker at this webinar, which earns up to 2.00 RAC credits towards a participant's RAC recertification upon full completion.

RAPS pre-approved webinar on “21 CFR Part 11 Compliance for Excel Spreadsheets”


      

 

Description:Spreadsheet applications are important to 21 CFR Part 11 compliance environments, given their versatility and user experience. The FDA expects these spreadsheets, such as MS Excel, to be compliant with their regulatory requirements, failure of which can result in issuance of warning letters. However, this compliance is not a given, because MS Excel is not inherently suited or built for 21 CFR requirements.

This two-hour webinar will offer participants ways by which to take their spreadsheets towards FDA compliance requirements and subsequent validation. In offering them these guidelines, it covers the following:

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 Documentation for Part 11

o Future Trends in 21 CFR 11 compliance for Excel Spreadsheets

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When:October 2, 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 GxP

o Consultants

o Quality VPs

o IT VPs

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Duration: 120 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

Phone: 800-447-9407

 




RAPS pre-approved webinar on “21 CFR Part 11 Compliance for Excel Spreadsheets”

Source: Press Release

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