Use of Excel Spreadsheets in FDA-Regulated Environments under 21 CFR Part 11

MessageThis Webinar is over
Date Sep 6, 2016
Time 10:00 AM PDT
Cost $199.00
Online
This seminar is intended to help you get familiar with the 21 CFR Part 11 Compliance Requirements for Excel Spreadsheets.
 In particular, this seminar is intended to present “How to Develop and Validate Excel Spreadsheets for 21 CFR Part 11 Compliance.” 
 In FDA-regulated industry, it is imperative that firms should demonstrate FDA-compliant implementation of 21 CFR Part 11 (Part 11) requirements applicable to manufacturers for drugs, biologics/biosimilars and medical devices including IVDs. 
 This seminar will help firms to adequately develop and implement part 11 and Excel spreadsheet computer system validation.  Adequate implementation of Excel spreadsheets for Part 11 compliance will ensure quality and integrity of GxP data and avoid FDA enforcement actions leading to 483s and warning letters.
 FDA frequently states “failure to maintain complete data; failure to prevent unauthorized access or changes to data and to provide adequate controls to prevent omission of data; “failure to validate computer software for its intended use according to an established protocol when computers or automated data processing systems are used as part of production or the quality system….”
 This seminar will provide great opportunities to check your current practices and/or also to ensure your compliance for part 11 requirements for Excel spreadsheets of GxP data.

 


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