Webinar Compliance, Online Event
16/11/2020
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
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Invited Speakers:
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David NettletonDavid 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.
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