2014 - Using Excel Spreadsheets in FDA Regulated Environment

Instructor: Mukesh Kumar
Description:
Excel spreadsheets are easy and convenient to use for handling common data capture and analysis functions. FDA accepts data in Excel spreadsheets provided it meets the criteria of confidentiality and integrity defined within 21 CFR Part 11, GAMP 5 and related regulations. Excel can be made FDA compliant with simple procedures and practices to meet regulatory requirements. This seminar provide insight into regulatory requirements and inherent limitations in “Out of the Box” Excel, validation techniques, documentation requirements, and risk-based evaluation of Excel spreadsheets. Practical strategies and case studies will be used to highlight common issues and potential solutions.
Why Should you Attend:
Capability to use Excel creates an inexpensive and handy tool for FDA regulated industry, particularly R&D operations and early stage development activities. However, companies frequently struggle with understanding and implementing applicable regulations on spreadsheets. Many companies use invalidated spreadsheets leading to negative audit findings. This seminar will address all these issues by providing methods for planning and executing spreadsheet validations that satisfy FDA requirements.
Objectives of the Presentation:
Regulatory requirements for spreadsheets
Spreadsheet design considerations and validation methods
Risk based evaluation and qualification of spreadsheets
Documentation requirements
Common FDA audit findings and solutions
Who can Benefit:
System owners and personnel who create or use spreadsheets in FDA regulated areas
QA / QC managers, executives and personnel
IT / IS managers and personnel
Validation specialists
Software quality reviewers
Regulatory affairs and training personnel
Quick Contact
http://www.onlinecompliancepanel.com/ecommerce/web...
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OnlineCompliancePanel LLC,
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Fremont, CA 94536, USA