January 26, 2024 10:00 AM PST - 11:30 AM PST
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.
Upon completion of this session, attendees will learn how to:
1. Why are spreadsheets so popular?
2. Why is compliance a problem?
3. Developing Part 11 applications
5. Using the validated application
7. How to turn on 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:
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.
Attendees may cancel up to two working days prior to 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 email@example.com