ComplianceOnline Full Day Virtual Seminar - Design and Validation of Excel Spreadsheets: Step-by-Step(October 26, Tuesday 10:00 AM EDT | 05:00 PM EDT)

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.
Learning Objectives:

  • 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.

How It Works:

This excel validation virtual event has 6 modules. Our speaker will deliver the modules using PowerPoint slides. Practical examples, case studies and exercises will be dispersed into and between the presentations. About 50% of the time will be dedicated to discussions and practical sessions. As an example, attendees will receive fill-in templates to document validation steps from beginning to end, in other words, from validation planning and writing specifications to testing and writing the validation report. Application examples will be generic and easy to understand. The results will be discussed and conclusions will be documented by the presenter and will be available for download from a special reference website. Attendees can use the templates to validate and document their own Excel applications. At the end of each module participants can ask verbal questions through the audio line. Written questions can be submitted at any time.
(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 Benefit:

  • 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

For More Information: