Webinars >>FDA Regulations
Validation of Excel Spreadsheet for Use in FDA Regulated Environment

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 provides 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:
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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.
Areas Covered in the Session:
  • 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 will benefit:

The following individuals or disciplines will benefit from attending this Webinar.
  • 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
Date: January 10, 2019
Time: 12 PM ET        
​Duration: 60 Minutes

Speaker
Mukesh Kumar, PhD, RAC, Brij Strategic Consultations, USA
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    For more info, fill the box below. We will contact you within 24 hrs.
For additional information on the workshop agenda and logistics, please call 410-501-5777 or email: info@fdamap.com