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Réf : 28870
Evènement :Validation and Use of Excel® Spreadsheets in FDA Regulated Environments

Date :Jeudi 14 Février 2019

Lieu :Palo Alto
2479 East Bayshore Road,
Suite 200
94303 Palo Alto, California, États-Unis

Type :Conférence & Séminaire - Audience Internationale

Accréditation :--


 

Informations

Editorial

This excel validation training / webinar will demonstrate how to design spreadsheets for Part 11/GxP /SOX/HIPAA compliance. And how to document planning, specifications, installation, testing and changes to meet FDA requirements.

Objectives

Excel® Applications are widely used in laboratories, offices and manufacturing e.g., for data capture, data manipulation and report generation. Regulations such as FDA's GxPs and 21 CFR Part 11 require users of software and computer systems to demonstrate and document data accuracy, integrity and confidentiality. Out-of-the box Excel® has not been designed for regulated environments. However, with a good knowledge of Excel® capabilities combined with good procedures and practices on how to validate and use Excel® the requirements can be met. This webinar will demonstrate how requirements will be met.

Program

Hand -Outs:

For easy implementation, Attendees will receive:

  • User Manual with Excel functions that help to comply with FDA requirements
  • SOP: Validation of spreadsheet applications
  • SOP: Development and use of spreadsheets in regulated environments
  • Gap analysis/checklist for Macros and Spreadsheet applications
  • Examples for validation documents

Note: These complimentary hand-outs will be sent to customers on request. Please email customercare@complianceonline.com for these documents, stating your order number, and they will be emailed to you within 4 working days.

Lieu

Plan et itinéraire
Adresse de la conférence :
Palo Alto
2479 East Bayshore Road,
Suite 200
94303 Palo Alto
California, États-Unis
Tél : +1-888-717-2436
Plan et itinéraire

Renseignements

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Précisions

Validation and Use of Excel® Spreadsheets in FDA Regulated Environments Médecine - Pharmacie
excel spreadsheet validation compliance training, fda excel spreadsheet validation training, spreadsheet regulatory requirements, document planning, document specifications, 21 cfr part 11 compliance, gxp compliance training, sox
Professionnels, Pharmaceutical and medical device industry professional Contract laboratories All developers and users of spreadsheet applications Validation specialists QA/QC managers and personnel Production and lab managers Regulatory affairs Professionals Training department Personnel Documentation department Personnel Consultants
10 -- --
English

Divers

Pour plus d'informations sur Validation and Use of Excel® Spreadsheets in FDA Regulated Environments, veuillez contacter ComplianceOnline

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