Excel Spreadsheet Validation for FDA 21 CFR Part 11
- DATE:
- August 12, 2014
- START DATE/TIME:
- August 12, 2014 10:00 AM
- END DATE/TIME:
- August 12, 2014 11:30 AM
- TIME ZONE:
- (GMT -8:00) Pacific Time (US & Canada)
- EVENT TYPE:
- Webinar
- HOST:
- GlobalCompliancePanel
- PHONE:
- 8004479407
- EMAIL:
- [email protected]
- WEBSITE:
- Click here to Visit
Description
Overview:
This webinar will describe the regulatory and business requirements for Excel spreadsheets, using examples from FDA recommendations. It will then cover the design and installation of those Excel Spreadsheets, to ensure the integrity of the data, and will discuss how to ensure 21 CFR 11 compliance during the development, installation and maintenance of a spreadsheet application.
Why should you attend:
Spreadsheet Applications such as MS Excel are frequently used in 21 CFR 11 compliant environments, but they were not specifically designed for regulated environments and their development is not optimized for 21 CFR 11 compliance. However, the FDA expects that spreadsheets be compliant and lack of compliance can result in a warning letter. Consequently, validation of Excel Spreadsheet Applications is required as part of a 21 CFR 11 compliant environment.
Areas Covered in the Session:
Requirements for Excel Spreadsheets
FDA Part 11 Validation Guidance
Compliance Problems with Spreadsheets
Design Specifications for 21 CFR 11 compliance
How does the FDA Design and Use spreadsheets
Documentation for Part 11
Future Trends in 21 CFR 11 compliance for Excel Spreadsheets
Who Will Benefit:
Quality Managers
Quality Engineers
Small business owners
Internal and external auditors
Management Reps
FDA inspectors
Consultants
For More Info Click Here: http://bit.ly/1mcrfof
- Related Portals:
- Food & Beverage, Pharmaceutical
MORE EVENTS
-
Methods for Measuring Small Defects in Curved Displays: Evaluating Approaches and System...
Join a webinar on Dec 17 hosted by Radiant Vision Systems as we present the results of several lab tests measuring a 1500R LED-lit curved display...
-
OPC Webinar: OPC to Excel
Find out how to connect OPC to Microsoft Excel with quick drag-and-drop. Visualize OPC data with recently released OPC Expert features. This...
-
Texas A&M University 75th Annual Instrumentation & Automation Symposium
The Instrumentation and Automation Symposium for the Process Industries, now in its 75th year, continues to educate professionals and students. The...
-
NextGen SCADA Global 2020
Join leading specialists to critically review the opportunities and challenges presented by Next-Gen SCADA systems, including system integration,...
-
ARC Industry Forum Orlando 2020
The 24th Annual ARC Industry Forum in Orlando, Florida will learn more about how digitizing factories, cities, and infrastructure will benefit...
RELATED
-
Reducing the Risk of Recalls
By Darcy Simonis, ABB food and beverage
With research showing that only 21 per cent of all product recalls over the last decade were detected by... -
Emerson releases ASCO Series 273 Pinch Valve for the life sciences market
The Series 273 features a pinching mechanism that remains firmly in place to provide better tube retention and eliminates breakage or damage to the...
-
Rockwell Automation helps Ithaca Beer enhance brewery automation process
Working with OBG, Ithaca Beer Co. upgraded to a semi-automated brewing process based on the FactoryTalk Craft Brew solution from Rockwell...
-
Fast-Growing Small Manufacturers Transformed with Automated Inventory Control
By Thomas R. Cutler
Only when a small manufacturer has a grasp on operation elements can the promise of lean manufacturing and continuous process... -
Traceable Trust with Trust-Free Tech
By Darcy Simonis, ABB
While Bitcoin itself has divided many and attracted criticism, the technology that it is built upon, the blockchain, has...