Validation and Use of Excel® Spreadsheets in FDA Regulated Environments 2019
14 Feb 2019
Webinar
Description
Topics
How to design spreadsheets for Part 11/GxP/SOX/HIPAA compliance?
FDA and other agency’s requirements for spreadsheet validation - What do inspectors ask and what documents should be available
When, what and how much to test?
Validation during design, development, installation and on-going use
How to ensure and validate spreadsheet integrity and security for GxP and Part 11?
Dealing with standard Excel functions: Recommendations from GAMP5
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
Contract laboratories
Pharmaceutical and medical device industry professional
Validation specialists
All developers and users of spreadsheet applications
Production and lab managers
QA/QC managers and personnel
Training department Personnel
Regulatory affairs Professionals
Consultants
Documentation department Personnel
Past Events
Validation and Use of Excel® Spreadsheets in FDA Regulated Environments 2019 - 14 Feb 2019, Webinar (50849)
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: Medical device, Medical laboratories, Pharma
