FDAnews Announces — Spreadsheet Validation 2016: Tools and Techniques to Meet FDA Requirements Webinar, Aug. 31, 2016

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Can manufacturers assure that their Microsoft Excel speadsheets are validated, and meet strict 21 CFR Part 11 standards? Join trusted spreadsheet validation expert, David Harrison for a 90-minute webinar where he’ll discuss the best practices and available options for validating spreadsheets.

FDAnews

FDAnews

Spreadsheet Validation 2016:
Tools and Techniques to Meet FDA Requirements
**An FDAnews Webinar**
Aug. 31, 2016 — 10:00 a.m. – 12:30 p.m. ET
http://www.fdanews.com/spreadsheetvalidation2016?hittrk=16810VOCUS

Do the Microsoft Excel spreadsheets pass FDA muster? Can manufacturers assure they are validated, and meet strict 21 CFR Part 11 standards?

What needs validation and where should manufacturers focus their efforts? Do changes to
Excel within Office 2016, Office 365 and cloud based applications affect the validation approach?

Join trusted spreadsheet validation expert, David Harrison for a 90-minute webinar when he’ll discuss the best practices and available options for validating spreadsheets, including:

  • Exactly what the FDA looks for and why, including examples of noncompliance and regulatory concerns with respect to 21 CFR 210-211, 21 CFR Part 11 and 21 CFR Part 820
  • Spreadsheet validation "gaps" the FDA is targeting
  • How to choose an approach for efficient and repeatable validation which fits into the traditional QA and validation processes
  • How to generate spreadsheet specifications and qualification protocols
  • How to test spreadsheets and macros
  • How to plan, manage and resource an effective project
  • Sources of FDA publications on spreadsheet use and validation

Register today and close the compliance gap.

Meet the Presenter:
David Harrison is a principal consultant with CSV Compliance Limited and specializes in pharmaceutical/medtech compliance and computer system validation. David has managed the introduction and implementation of 21 CFR Part 11 and computerized system validation projects for many key blue-chip clients — including more than 250 spreadsheet validation projects. He has worked within various quality assurance and consultancy roles within the drug, biotech and device industries. Previously, David was responsible for spreadsheet validation and computer system validation for ABB Consulting.

Who Will Benefit:

  • Auditors
  • QA/QC specialists
  • Clinical research directors/managers
  • Compliance officers
  • Data management and statistics personnel
  • Financial accountants and auditors (SOX404)
  • Pharmaceutical and cGMP auditors
  • R&D staff
  • Study monitors/coordinators
  • Validation specialists, scientists and engineers
  • PLUS every compliance professional who uses Microsoft Excel spreadsheets

Webinar Details:
Spreadsheet Validation 2016:
Tools and Techniques to Meet FDA Requirements
Aug. 31, 2016 — 10:00 a.m. – 12:30 p.m. ET
http://www.fdanews.com/spreadsheetvalidation2016                

Tuition:
$287 per site

Easy Ways to Register:
Online: http://www.fdanews.com/spreadsheetvalidation2016                    
By phone: 888-838-5578 or 703-538-7600

About FDAnews:
FDAnews is the premier provider of domestic and international regulatory, legislative, and business news and information for executives in industries regulated by the US FDA and the European Medicines Agency. Pharmaceutical and medical device professionals rely on FDAnews' print and electronic newsletters, books and conferences to stay in compliance with international standards and the FDA's complex and ever-changing regulations.

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Michelle Butler
FDANEWS
+1 (703) 538-7665
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