Equipment Calibration in FDA QSR â€“ Regulations and Warning Letters (Medical Device)
Venue: Online Event
|Event Date/Time: May 11, 2012||End Date/Time: May 11, 2012|
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 â€œno calibration requiredâ€.
Your Quality Management System (QMS) should be able to address these questions about your Inspection, Testing, and Measurement (IM&TE). If not, then your team needs to attend this webinar!
- Is your IM&TE suitable for its intended purposes and is capable of producing valid results?
- Do you have procedures for handling, preservation, and storage of IM&TE?
- Do you understand the meaning of accuracy and precision?
- Have you established remedial actions when the equipment doesn't meet limits for accuracy and precision?
- Do your calibration records include the equipment identification, calibration dates, the individual performing each calibration, and the next calibration date?
This webinar explains concepts required for a calibration program that satisfies FDAâ€™s Quality System Regulation (QSR), ISO 13485, and ISO 9001. The webinar defines the concepts of accuracy and precision that define the measuring equipmentâ€™s requirements. It also explains the meaning of traceability. With these concepts in hand, the webinar moves to an analysis of FDA requirements and ISO 13485 requirements.