SUBSCRIBE TO TMCnet
TMCnet - World's Largest Communications and Technology Community

TMC NEWS

TMCNET eNEWSLETTER SIGNUP

Two Day Computer systems Validation (CSV) for Excel Spreadsheets Workshop (San Diego, CA, United States - December 14-15, 2017)
[October 30, 2017]

Two Day Computer systems Validation (CSV) for Excel Spreadsheets Workshop (San Diego, CA, United States - December 14-15, 2017)


DUBLIN, October 30, 2017 /PRNewswire/ --

The "2 Days Workshop: Computer systems Validation (CSV) for Excel Spreadsheets" conference has been added to Research and Markets' offering.

Research and Markets Logo

Spreadsheets such as Excel, are available for creating a wide range of end user applications, including widespread use in the laboratory, creating customized statistical analyses, the creation of local databases, data mining, and multivariate analysis. These may be used for GxP regulated activities, and they present particular compliance challenges, as Excel and other spreadsheets are not originally designed for the regulated environment.

GxP records generated by spreadsheet calculations are electronic records and should comply with FDA's 21 CFR Part 11 and the European Annex 11. For critical records Part 11 controls, such as data accuracy and data integrity, should be implemented. Currently thee are no specific industry FDA guidelines on using spreadsheets in regulated environments. However, the flexibility and power of the spreadsheet allows users to create tools that range from performing simple calculations to sophisticated analysis of a major clinical study, or laboratory or manufacturing data.



This makes spreadsheets a very powerful and useful tool in the GxP environment especially when coupled with the fact that it is easy to build spreadsheet applications without much training.

Areas Covered


Part 11 / Annex 11 Computer Systems Validation (CSV) is be implemented in order to increase the integrity, accountability and security of the spreadsheets and achieve GxP Compliance. CSV enables the level and rigor of specification and verification applied to spreadsheets to be based on spreadsheet risk, complexity, and novelty. This hands-on seminar will provide the attendees with the tools for successful computer systems validation for Excel Spreadsheets.

It will address the following topics:

1. Types and Uses of Excel Spreadsheets (e.g. disposable spreadsheets, spreadsheets used as documents, etc.)
2. Risk Based Approach and Controls to Excel Spreadsheets (incl. Excel specific risks)
3. Computer Systems Validation for Excel (will cover 21 CFR 11, Annex 11)
4. The FDA's Perspective and Use of Spreadsheets
5. Examples of Typical Approaches for Excel Validation
6. How to tailor your risk based methodology to Excel to determine the level of validation required
7. 483s and Warning Letters for Excel and other Spreadsheets
8. Quiz: Test your understanding of Computer Systems Validation for Excel

For more information about this conference visit https://www.researchandmarkets.com/research/hdtslk/2_days_workshop

Media Contact:


Research and Markets
Laura Wood, Senior Manager
press@researchandmarkets.com  

For E.S.T Office Hours Call +1-917-300-0470
For U.S./CAN Toll Free Call +1-800-526-8630
For GMT Office Hours Call +353-1-416-8900

U.S. Fax: 646-607-1907
Fax (outside U.S.): +353-1-481-1716

 




[ Back To TMCnet.com's Homepage ]







Technology Marketing Corporation

35 Nutmeg Drive Suite 340, Trumbull, Connecticut 06611 USA
Ph: 800-243-6002, 203-852-6800
Fx: 203-866-3326

General comments: tmc@tmcnet.com.
Comments about this site: webmaster@tmcnet.com.

STAY CURRENT YOUR WAY

© 2018 Technology Marketing Corporation. All rights reserved | Privacy Policy