Equipment Calibration in FDA QSR – Regulations and Warning Letters

This webinar explains concepts required for a calibration program that satisfies FDA’s Quality System Regulation (QSR), ISO 13485, and ISO 9001. It defines the concepts of accuracy and precision that define the measuring equipment’s requirements. It also explains the meaning of traceability.

Why Should You Attend:

Managing your calibration program is a key element in delivering good products and services. You must satisfy the QMS requirements but first you need to understand them. You need to know when a piece of equipment needs to be in the calibration recall program and when you can identify it as “no calibration required”. 

Areas Covered in the Seminar:

• Metrology requirements of FDA QSR.
• Metrology requirements of ISO 13485 and ISO 9001.
• Understanding metrology terms.
  • Accuracy
  • Precision
  • Traceability
• Chapter 7 of the FDA's Quality Systems Manual.
• ISO 10012:2003 requirements.

Who Will Benefit:

This seminar is for people involved in the metrological aspects of medical device manufacturing and design. The principles are larger in scope than medical devices, and apply to all manufacturing processes. Attendees should understand the concepts of manufacturing processes from the design or production view.

People in the following roles can especially benefit from the knowledge in this webinar:

• Quality Managers
• Quality Professionals
• Production Managers
• Production Supervisors
• Manufacturing Engineers
• Production Engineers
• Design Engineers
• Process Owners