Validation and Use of Excel Spreadsheets in FDA Regulated Environments 2019
17 May 2019
Webinar
Description
Topics
Learning from FDA warning letters related to spreadsheets
FDA and other agency`s requirements for spreadsheet validation - What do inspectors ask and what documents should be available
Validation during design, development, installation and on-going use
How to design spreadsheets for Part 11/GxP/Annex 11 compliance
Dealing with standard Excel functions: Recommendations from GAMP5
When, what and how much to test?
How to apply risk based validation to spreadsheet applications
How to ensure and validate spreadsheet integrity and security for Part 11?
How FDA is using spreadsheets
Validation of `single use` spreadsheet applications
Examples from manufacturing, laboratories and offices
How to document planning, specifications, installation, testing and changes
Who should Attend
Attendees from:
Contract laboratories
Pharmaceutical and medical device industry
Validation specialists
All developers and users of spreadsheet applications
Production and lab managers
QA/QC managers and personnel
Training department
Regulatory affairs
Consultants
Documentation department
Past Events
Validation and Use of Excel Spreadsheets in FDA Regulated Environments 2019 - 17 May 2019, Webinar (64028)
Important
Please, check "Validation and Use of Excel Spreadsheets in FDA Regulated Environments" official website for possible changes, before making any traveling arrangements
Event Categories
Health & Medicine: Healthcare, Medical device, Medical laboratories, Pharma
