Organizing a webinar by Ludwig Huber on July 26 on the topic, -Validation and Use of Excel Spreadsheets in FDA Regulated Environments-
Chicago, IL July 12, 2018 - Validation and Use of Excel Spreadsheets in FDA Regulated Environments is the topic of a 75-minute webinar that Compliance4All, a leading provider of professional trainings for the areas of regulatory compliance, is organizing. Ludwig Huber, director and editor of Lab compliance the global online resource for validation and compliance, who has given more than 300 presentations on GLP/GMP, 21 CFR Part 11 and Validation around the world, will be the speaker at this webinar.
The chief learning of this session is about how to design spreadsheets for compliance by users of MS Excel to demonstrate and document data accuracy, integrity and confidentiality of software and computer systems in accordance with regulations such as HIPAA, Sarbanes Oxley Act and the FDA's GxP and 21 CFR Part 11. http://bit.ly/2unHAON
Microsoft Excel is used in a wide variety of applications in laboratories, offices and manufacturing for data capture, data manipulation and report generation. To ensure that this data is accurate, has integrity, and is confidential, regulations such as HIPAA, Sarbanes Oxley Act and FDA's GxP and 21 CFR Part 11 require users of software and computer systems to demonstrate and document these traits.
Excel per se has not been designed for regulated environments. However, it is possible for practitioners and professionals working in the regulated environments to acquire knowledge of Excel capabilities, which, when combined with good procedures and practices on how to validate and use Excel requirements, can help meet the requirements set out by the regulatory agencies for validation and use of Excel Spreadsheets. The FDA itself widely uses Excel and complies with its own regulations. So, that should serve as an example of how it is possible to do this.
The ways of doing this and ensuring Excel sheet validation will be the main learning that the participants of this webinar will walk away with. Over 75 minutes of learning, Dr. Huber will cover the following areas:
- Regulatory requirements for spreadsheets; FDA Part 11, GxP, HIPAA, Sarbanes-Oxley
- Recommendations from the new GAMP® 5 and EU Annex 11
- How to design spreadsheets for compliance
- How to ensure and validate spreadsheet integrity
- When, what and how much to test?
- Validation 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.
To help them with easy implementation of all that they have learnt, Dr. Huber will offer the following to the participants:
- The Lab compliance documents
- 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.