Description

In this interactive webinar, our 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 of 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.

Course Objectives:

Upon completion of this session, attendees will learn how to:

• Develop GxP compliant spreadsheet applications
• 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
• 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
• Specify and test your application

Areas covered:

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

Who Will Benefit:

This webinar is intended for professionals in the Medical Device, Biotechnology, and Pharmaceutical Industry. Personnel in the following roles will benefit:

• All Excel users in the regulated environment
• QA Departments
• QC Departments
• IT Departments
• Laboratory staff
• Managers and Executives