Mohammed Abdul Jawad

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GxP-Compliant Calibration: Learning from Form 483s and Warning Letters

GxP-Compliant Calibration: Learning from Form 483s and Warning Letters

FREE ON-DEMAND WEBINAR


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View the Presentation Slides

Watch the Post-Webinar Q&A Video & Find the full-transcript of the Video 


About the Webinar

In this webinar, the speakers have briefly outlined the practices, processes and regulations governing calibration in GxP-regulated applications. 


They have also analyzed 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
  • Engineers
  • Process Managers
  • Project Managers

Watch the Webinar Now

View the Presentation Slides

Watch the Post-Webinar Q&A Video & Find the full-transcript of the Video 


Speakers

d64dbb90.jpgPAUL DANIEL

Senior Regulatory Compliance Expert

Paul Daniel is the Senior Regulatory Compliance Expert at Vaisala. His specialties include mapping, monitoring, and computerized systems. 

At Vaisala, Paul oversees and guides the validation program for the Vaisala viewLinc environmental monitoring system. He serves as a customer advocate to ensure the viewLinc environmental monitoring system matches the demanding requirements of life science and regulated applications. Paul also shares his GMP experience through regular blog contributions, webinars, and seminars around the world. Paul’s expertise in the demanding GxP world is applicable to any industry where measurement is critical to product quality. 


18e770d6.jpgHEATHER WADE

Metrologist

Heather Wade is an ASQ-CCT and ASQ-CQA metrologist. 


Before moving to her career in calibration, Heather’s experience included work as a microbiologist, filter test specialist, laboratory compliance officer, and extraction and analytical chemist. She is also a co-author of The Metrology Handbook, 2nd Edition.


Source: Vaisala 

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