Full Day Virtual Seminar - Design and Validation of Excel Spreadsheets: Step-by-Step

Instructor: Dr. Ludwig Huber
Product ID: 701761
  • Duration: 6 hrs

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

In this excel Spreadsheet validation full day webinar training, learn the best way to design and validate the excel spreadsheets. Learn what the requirements are of excel validation and how to implement it to comply with regulations.

Why Should You Attend:
Excel spreadsheets used in regulated environments should be validated and comply with other FDA requirements. In this interactive one-day on-line seminar Dr. Ludwig Huber will give an introduction to FDA, GAMP® 5 and other requirements for validation of excel sheet and present approaches for implementation. This is a comprehensive course covering validation, design, testing of functions along with how to apply risk based validation techniques for spreadsheet application. Learn best practices of document planning, specifications, installation, testing and changes.

Buy this 6 sessions CD pack prepared in Webinar format by quality and compliance expert Ludwig Huber to use for training your employees learning on Design and Validation of Excel Spreadsheets: Step-by-Step.

Learning Objectives:

Buy the CD pack and train your entire team to get a clear understanding of Design and Validation of Excel Spreadsheets:

  • Understand regulatory requirements for validation and use of Excel spreadsheets.
  • Understand how to effectively design and develop Excel spreadsheets for compliance.
  • Learn how to effectively validate Excel spreadsheets.
  • Lean what and how to test for Excel spreadsheets.
  • Learn how to maintain spreadsheets in a validated state.
  • Learn how to document Excel spreadsheet validation for FDA and other regulations.

About the CD Recordings:

The CD contains recording of Live Webinar which has a series of modules, each about 45 minutes long. Our speaker, Dr Ludwig Huber, has delivered the modules using PowerPoint slides. At the end of each module, there is an interactive portion where participants has asked questions and got the answers. The modules also include multiple-choice questions to help participants assure they understand the material. Some of the modules contain exercises for participants that help illustrate the points covered and further increase learning. The interactive portion includes a discussion of the questions and exercises. For people watching the CD can ask questions to the panelist by sending an email to and ComplianceOnline will co-ordinate with the panelist to get the answers.

Detailed Agenda , Duration , Hand-Outs , Who Will Benifit

Areas Covered in the Seminar:

  • Regulatory requirements for spreadsheets: Good Practice Regulations a 21 CFR Part 11.
  • Typical compliance problems with spreadsheets.
  • Recommendations from GAMP® 5.
  • Recommendations from FDA's two Information bulletins for: single users and multiple users of spreadsheet applications.
  • How to design spreadsheets for compliance and easy validation.
  • When, what and how much to test.
  • Testing of standard (native) Excel functions.
  • 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.

Detailed Agenda:

Module 1. FDA and International Requirements and Enforcement (45 min)

  • FDA regulations for development, clinical testing, manufacturing and quality control laboratories
  • Examples of FDA 483's and Warning Letters
  • Regulated vs. non-regulated spreadsheet applications
  • International regulations and guidelines related t: EU GMPs, Annex 11, PIC/S
  • Recommendations from Industry guides: GAMP ® 5, IEEE
  • 'Out of the Box' Excel deficiencies for compliance
  • Alternative solutions for compliance
  • Interactive discussion

Module 2: Planning for Efficient Validation and Compliance (30min)

  • Developing a compliance and validation policy
  • Developing a master plan, SOPs and templates
  • Search for and documenting all spreadsheet Installations
  • Standardizing hardware, software, documentation
  • Train developers and users
  • Including spreadsheet applications in regular audits
  • Interactive discussion

Module 3. Design of Excel Spreadsheets for Part11/GxP Compliance (45 min)

  • Design for error detection
  • Design with integrity in mind
  • Using MD5 checksums to document spreadsheet and data integrity
  • Design for authenticity
  • Design for spreadsheet and data security
  • Building audit trail into Excel spreadsheets
  • Interactive discussion

Module 4: Validation of Excel Spreadsheets - Step-by-Step (150 min)

    • Developing a project validation plan
    • Writing specifications
    • Testing during development and during installation
    • Testing of Excel standard/native functions yes/no?
    • Validation and documentation of VBA scripts
    • Writing the validation report
    • Interactive discussion

Module 5: Maintaining the Spreadsheet in a Validated State (45 min)

  • Regular checks of spreadsheets
  • Training of new users
  • Maintain compliance during changes
  • Lear how FDA complies with their own regulation
  • Documentation for Part 11compliance
  • Interactive discussion

Module 6. Putting it all together for different applications

  • Going though complete examples: from design to retirement
  • Interactive discussion


(All in EST)

10.00-10.45 - FDA and International Requirements and Enforcement (45 min)

10.45-11.15 - Planning for Efficient Validation and Compliance (30 min)

11.15-12.00 - Design of Excel Spreadsheets for Part11/GxP Compliance (45 min)

12.00-01.00 - Validation of Excel Spreadsheets - Step-by-Step - Part ! (60 min)

01:00-02:00 - Lunch Break

02:00-03:30 - Validation of Excel Spreadsheets - Step-by-Step - Part II (90 min)

03:30-04.15 - Maintaining the Spreadsheet in a Validated State (45 min)

04.15-04:45 - Putting it all together for different applications (30 min)

04:45-05:00 - Wrap-up and final discussion


10+ Reference Documents for Easy Implementation.This material will help attendees to quickly implement what they have learned in the seminars:

  • SOPs:
    • Validation of spreadsheet applications
    • Development and use of spreadsheets in regulated environments
    • Change control of software and computer systems
  • Checklist for Macros and Spreadsheet applications.
  • Examples.
    • A full set of validation examples from planning, writing specifications, and design to testing and reporting
  • Software and validation package: File integrity check with MD5 Hash Calculations.
  • FDA 483 form inspectional observations, establishment inspection reports and several warning letters with deviations related to Excel.

Who Will Benifit:

  • All developers and users of spreadsheet applications in FDA regulated industries, e.g., pharmaceutical and device development, clinical trials, manufacturing and QC laboratories
  • Validation specialists
  • QA managers and personnel
  • IT professionals
  • Production and lab managers
  • Regulatory affairs
  • Training department
  • Documentation department
  • Consultants

Instructor Profile:
Ludwig Huber:

  • Director and chief editor of, the global on-line resource for validation and compliance issues.
  • Chairman, presenter and panel discussion member at US-FDA Industry Training sessions and conferences
  • Team and/or review member of PDA's task forces "21 CFR Part 11", of US-FDA internal documents, and of the GAMP special interest group on Laboratory Equipment
  • Member of the FDA Spreadsheet Design and Validation Information Bulletin Review Team
  • Author of the books "Validation of Computerized Analytical and Networked Systems", and of the popular Macro & Spreadsheet Quality Package from Labcompliance.
For more information on Ludwig Huber Click here.

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

Product Reviews

This product hasn't received any reviews yet. Be the first to review this product! Write review

Best Sellers
You Recently Viewed