RAPS pre-approved webinar on “Excel Spreadsheets –Step-By-Step Instructions for Compliance”
11/22/2012

In order to avoid 483s from the FDA; having a compliant and validated Excel spreadsheet is necessary. At this webinar; participants will learn ways of working on Excelin order to avoid 483s.

Online PR News – 22-November-2012 – Wilmington – Summary:David Nettleton, FDA Compliance Specialist, will be the speaker at aRAPS pre-approved webinaron the topic “Excel Spreadsheets –Step-By-Step Instructions for Compliance” that is being organized byGlobalCompliancePanel, a leading regulatory and compliance continuing education training provider,on December 5. This 75-minute webinar earns up to 1.25 RAC credits towards a participant's RAC recertification upon full completion.
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Description:
In order to avoid 483s from the FDA; having a compliant and validated Excel spreadsheet is necessary. At this webinar; participants will learn ways of working on Excelin order to avoid 483s. At this highly interactive session, participants will get a hands-on feel of working with Excel spreadsheets that ensure compliance. At the end of this learning session, they will have understood ways by which to configure and validate a GxP-compliant spreadsheet application.
At this webinar, each participant will both get step-by-step instructions and learn to implement them with help from the Expert. This is the unique feature of this webinar, which has a live workshop-like session. Bringing one’s own laptop, by which their learning will be made more effective; is recommended.
Areas covered in the session:
o Develop spreadsheet applications that are GxP compliant.
o Avoid 483s and warning letters. Critical data, such as laboratory information and other GxP data, is often recorded in spreadsheet applications and are subject to regulatory inspection.
o Learn how to use Excel’s built in 21 CFR Part 11 features.
o Apply features required for GxP environments without programming macros.
o Validate your application with minimal documentation.
o Follow along as we configure Excel for audit trails, security features, data verification, and multiple concurrent users.
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When:December 5, 10:00 AM PDT | 01:00 PM EDT
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By whom:
Founder of Computer System Validation (CSV), David Nettleton is an FDA Compliance Specialist for 21 CFR Part 11, HIPAA and Computer System Validation. His latest book, Risk Based Software Validation - Ten easy Steps, relates to the development, purchase, installation, operation and maintenance of computerized systems used in regulated applications.

He specializes in performing gap analysis, remediation plans, SOP development, vendor audits, training, and project management. He has completed more than 185 mission critical software validation projects. These have included clinical trial, blood bank, medical devices, document control, corrective action, laboratory instruments, electronic data capture, laboratory information management systems and so on.

An accomplished author, David has written extensively on a range of Compliance issues. He is co-author of Commercial Off-the-Shelf (COTS) Software Validation for 21 CFR Part 11 Compliance (Davis Horwood International and PDA - www.pda.org), and Electronic Record Keeping; Achieving and Maintaining Compliance with 21 CFR Part 11 and 45 CFR Parts 160, 162, and 164 (Interpharm/CRC - www.crcpress.com).
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For whom:
The webinar will benefit
o All Excel users
o IT
o QA
o QC
o Laboratory staff
o Managers
o Executives
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Duration: 60 minutes
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To enroll for this webinar, contact
webinars@globalcompliancepanel.com
Phone: 800-447-9407