On-Demand Webinar: GxP-Compliant calibration: learning from form 483s and warning letters
On-Demand Post-Webinar Questions & Answers:
In this webinar we briefly outline the practices, processes and regulations governing calibration in GxP-regulated applications. We also analyze several calibration-related Form 483s and Warning Letters issued over the last few years in a range of regulated industries (Drugs, Medical Devices, Nutraceuticals, and Cosmetics). Each Form 483 and Warning Letter is a cautionary tale for those calibrating instruments and devices for use in federally regulated applications.
Vaisala’s Senior Regulatory Expert Paul Daniel is joined by Heather Wade of Heather Wade Group, LLC. Paul and Heather will review several Warning Letters and 483 observations in order to understand the technical aspects of each calibration failure and discuss the principles and practices that can solve the violations. To err is human; failure to calibrate properly can result in enforcement actions. This webinar provides practical lessons on how to meet FDA calibration requirements and avoid dealing with such actions.
This webinar was created for:
- Calibration Managers
- Quality Assurance & Quality Control
- Facilities Management
- Information Technology
- Regulatory Compliance
- Process Managers
- Project Managers