Validation and Use of Excel® Spreadsheets in FDA Regulated Environments

Instructor: Dr. Ludwig Huber
Product ID: 701242
  • Duration: 75 Min

recorded version

1x Person - Unlimited viewing for 6 Months
(For multiple locations contact Customer Care)
Recorded Link and Ref. material will be available in My CO Section

Training CD

One CD is for usage in one location only.
(For multiple locations contact Customer Care)
CD and Ref. material will be shipped within 15 business days

Customer Care

Fax: +1-650-963-2556


Read Frequently Asked Questions

This excel validation training/ webinar will demonstrate how to design spreadsheets for part 11/GxP /SOX/HIPAA, document planning, specifications, installation, testing and changes to meet FDA requirements.

Why Should You Attend:

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 validate and use Excel® the requirements can be met. This webinar will demonstrate how requirements will be met.

Hand -Outs:

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
  • Examples for validation documents

Note: These complimentary hand-outs will be sent to customers on request. Please email for these documents, stating your order number, and they will be emailed to you within 4 working days.

Areas Covered in the Webinar:

  • FDA and other agency’s requirements for spreadsheet validation - What do inspectors ask and what documents should be available.
  • How to design spreadsheets for Part 11/GxP/SOX/HIPAA 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 GxP and Part 11?
  • How to apply risk based validation to spreadsheet applications?
  • Validation of 'ad hoc' spreadsheet applications.
  • How to document planning, specifications, installation, testing and changes?
  • Examples from manufacturing, laboratories and offices.

Who will Benefit:

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

Instructor Profile:

Dr. Ludwig Huber, Ph.D., is the director of Labcompliance and editor of, 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". He has given multiple presentations mainly on GLP/GMP, 21 CFR Part 11 and Validation around the world. This included seminars, workshops and presentations for the US FDA, China SFDA, Korea MFDS, Singapore HSA, ISPE, Japan PDA, PIC/S and several other national health care agencies.

Follow us :
ComplianceOnline Banking Summit 2016 | Risk Management and Data Security - 80390SEM
21 CFR Part 11 Compliance for SaaS/Cloud Applications - 80202SEM

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