Product Id : FDB3451
Category : Clinical & Laboratory, FDA Compliance, Food, Drugs & Biologics, Information Technology, Medical Devices, QualityPresenter : David Nettleton
Scheduled On : March 14 2022 1:00 pm
US/Canada (Eastern Time - ET)
Duration : 75 Minutes
This interactive webinar by industry expert – David Nettleton will explain how to avoid FDA 483s by proper configuration and validation of GxP compliant spreadsheet applications. This webinar will help you follow the step-by-step instructions in real time as we configure Excel for audit trails, security features, and data entry verification. You will get a good understanding on how to validate your application with minimal documentation. It is advised to bring your laptop and use Excel for your own needs. This session will help you save time and cost and make you a superior Excel user.
Learning Objectives:
How to develop GxP compliant spreadsheet applications
Learn how to use Excel’s built in 21 CFR Part 11 features
Apply features required for GxP environments without programming macros.
Follow along as we configure Excel for audit trails, security features, data verification, and multiple concurrent users
Avoid 483s and Warning Letters
How to use cell and file protections
Reduce validation time and costs
Increase compliance while lowering resource needs
Validate your application with minimal documentation
Understand what does and does not need to be validated.
How to specify and test your application
Who Should Attend:
All Excel users in the regulated environment
QA Departments
QC Departments
IT Departments
Laboratory staff
Managers and Executives
Areas Covered in the Session :
1. Why are spreadsheets so popular?
Spreadsheet overview
What are they used for?
2. Why is compliance a problem?
How is it different from a calculator?
3. Developing Part 11 applications
Security
Versioning
Cell protection
Data entry checks
Audit trail
Data output formatting
4. Validation
Fill-in-the-blank validation templates
Step-by-step validation
5. Using the validated application
Maintaining, upgrading, re-validation
6. Examples
Requirements
Specifications
Test cases
7. How to turn on the audit trail
How to view the audit trail
David Nettleton
David Nettleton, is an FDA Compliance Specialist for 21 CFR Part 11, HIPAA, and Computer System Validation. His latest book is “Risk Based Software Validation – Ten easy Steps” that relates to the development, purchase, installation, operation and maintenance of computerized systems used in regulated applications. He specializes in performing gap analysis, remediation plans, SOP development, vendor audits, training, and project management. He has completed more than 185 mission critical software validation projects.
