Validation and Use of Excel® Spreadsheets in FDA Regulated Environments 2017
14 Dec 2017
Webinar
Description
Topics
Recommendations from the new GAMP® 5 and EU Annex 11
Regulatory requirements for spreadsheets; FDA Part 11, GxP, HIPAA, Sarbanes-Oxley
How to ensure and validate spreadsheet integrity
How to design spreadsheets for compliance
Validation of standard/native Excel functions?
When, what and how much to test?
Validation of `ad hoc` spreadsheet applications
How to apply risk based validation to spreadsheet applications
Examples from manufacturing, laboratories and offices
How to document planning, specifications, installation, testing and changes
Who should Attend
QA Managers and Personnel
Everybody developing Excel Worksheets for regulated environments
Analysts and Lab Managers
QC Managers and Personnel
Validation Professionals
Validation Groups
Documentation Department
Training Departments
Consultants
Past Events
Validation and Use of Excel® Spreadsheets in FDA Regulated Environments 2017 - 14 Dec 2017, Webinar (72027)
Important
Please, check "Validation and Use of Excel Spreadsheets in FDA Regulated Environments" official website for possible changes, before making any traveling arrangements
