World Conference Calendar

35128 Conferences

Validation and Use of Excel Spreadsheets in FDA Regulated Environments - Webinar by GlobalCompliancePanel

Added by davidross759 on 2010-10-12

Conference Dates:

Start Date Start Date: 2010-12-14
Last Date Last Day: 2010-12-14

Conference Contact Info:

Contact Person Contact Person: Webinars
Email Email:
Address Address: Online Training Webinar, DE, 19801, United States
Phone Tel: 800-447-9407
Phone Fax: 302-288-6884

Conference Description:

Excel Applications are widely used in laboratories, offices and manufacturing e.g., for data capture, data manipulation and report generation.

Regulations such as HIPAA, Sarbanes Oxley Act and FDA's GxP 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 requirements can be met. For example, the FDA is widely using Excel and complies with its own regulations.

Areas Covered in the Session:

* Regulatory requirements for spreadsheets; FDA Part 11, GxP, HIPAA, Sarbanes-Oxley.
* Recommendations from the new GAMP®5 and EU Annex 11
* How to design spreadsheets for compliance.
* How to ensure and validate spreadsheet integrity.
* When, what and how much to test?
* Validation of standard/native Excel functions?
* How to apply risk based validation to spreadsheet applications
* Validation of 'ad hoc' spreadsheet applications.
* How to document planning, specifications, installation, testing and changes
* Examples from manufacturing, laboratories and offices
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