Validation and Use of Excel Spreadsheets in FDA Regulated Environments

OVERVIEW:
Excel® Applications are widely used in laboratories, offices and manufacturing e.g., for data capture, data manipulation and report generation. Regulations such as FDA's GxPs 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 control, validate and use Excel® the requirements can be met. Attendees of this seminar will get all details on how requirements can be met.

Product Id : 501077
Instructor : Robert Michalik

Areas Covered in the Session:

• FDA and other agency's requirements for spreadsheet validation - What do inspectors ask and what documents should be available.
• Learning from FDA warning letters related to spreadsheets
• How to design spreadsheets for Part 11/GxP/Annex 11 compliance
• Validation during design, development, installation and on-going use
• When, what and how much to test?
• For Easy Implementation, Attendees Will Receive
• User Manual with Excel functions that help to comply with FDA requirements
• SOP: Validation of spreadsheet applications
• SOP: Development and use of spreadsheets in regulated environments
• Gap analysis/checklist for Macros and Spreadsheet applications

Who Will Benefit:

• Pharmaceutical and medical device industry
• Contract laboratories
• All developers and users of spreadsheet applications
• Validation specialists
• QA/QC managers and personnel
• Production and lab managers
• Regulatory affairs
• Training department
• Documentation department
• Consultants

IMPORTANT DATE:

Webinar Date: Wednesday, January 4, 2017 | 10:00 AM PST | 01:00 PM EST 

Duration: 75 Minutes

Others Details

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