Using Excel Spreadsheets in FDA Regulated Environment

Location: Attend Live Webinar
Date: 12^th – FEB -2015: 10:00 AM PST
Duration : 60 Mins

Speaker: Mukesh Kumar

Dr. Mukesh Kumar, leads the Regulatory Affairs and Quality Assurance departments at Amarex, a full service pharmaceutical product development company based in Germantown, MD (www.amarexcro.com). His key expertise is in regulatory affairs, clinical trials and multi-national project management for medicinal and diagnostic products.

Course 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.

Course Objective:

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.

Course Outline:

·  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

 
Target Audience:

· 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

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Kevin Roberts,

Training Manager,

kevin.roberts@complianzworld.com

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