Course Description:
In this interactive and hands-on webinar, our industry expert David Nettleton will explain how to avoid FDA 483s through proper configuration and validation of GxP-compliant spreadsheet applications.
In this 90-minute session, the instructor will provide step-by-step instructions in real-time as you learn how to 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 to this session and use Excel at your end for a complete and guided understanding of how to develop a GxP-compliant spreadsheet. 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
About the Instructor:
Computer System Validation’s principal, David Nettleton is an industry leader, author, and teacher for 21 CFR Part 11, Annex 11, HIPAA, software validation, and computer system validation. He is involved with the development, purchase, installation, operation, and maintenance of computerized systems used in FDA-compliant applications. His most popular book is Risk Based Software Validation - Ten Easy Steps, which provides fill-in-the-blank templates for completing a COTS software validation project. He has completed more than 300 mission-critical laboratory, clinical, and manufacturing software implementation projects. Services are available to guide companies to create and maintain the systems and procedures required to pass regulatory audits: product features, vendor audits, software validation, SOPs, training, gap analysis, remediation plans, and project management.
Refund Policy:
Attendees may cancel up to two working days before the course start date and the refund will be processed within two working days.
We will process/provide a refund if the webinar is canceled. Refunds will not be given to participants who do not show up for the webinar. On-demand Recordings can be requested in exchange. Webinar may be canceled due to lack of enrolment or unavoidable factors. Attendees will be notified 24 hours in advance if a cancellation occurs. Substitutions can happen at any time.
If you have any concerns about the content of the webinar and are not satisfied, please contact us at care@thecomplyguide.com
