Validation and Use of Excel® Spreadsheets in FDA Regulated Environments

Dr. Ludwig Huber
Instructor:
Dr. Ludwig Huber
Duration:
75 Minutes
Product Id:
501064
Access:
6 months

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Price Details
$190 Recorded
$390 Corporate Recorded
Price Detail Options
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

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?
  • Dealing with standard Excel functions: Recommendations from GAMP5
  • How to ensure and validate spreadsheet integrity and security for Part 11?
  • How to apply risk based validation to spreadsheet applications
  • Validation of 'single use' spreadsheet applications.
  • How FDA is using spreadsheets
  • How to document planning, specifications, installation, testing and changes
  • Examples from manufacturing, laboratories and offices

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


Speaker Profile
Ludwig Huber Ph.D., is the director and editor of Labcompliance the global online resource for validation and compliance. He is the author of the books "Validation and Qualification in Analytical Laboratories" and "Validation of Computerized Analytical and Networked Systems, Informa Healthcare". He has given more than 300 presentations mainly on GLP/GMP, 21 CFR Part 11 and Validation around the world. For more information, please visit Dr. Huber’s website www.ludwig-huber.com




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