The Value of Human Factors

By: Thomas Bento ,Sr. Regulatory Consultant.

The ISO 62366 is noted by FDA as a “Consensus” Standard, making it a gold standard

  • 22-October-2019| 11:00 AM ET | 08:00 AM PT | 10:00 AM CT Duration 60 Minutes

Preparing for and responding effectively and in a positive manner to an FDA postmarked surveillance visit

By: Dr. George Yanulis ,Medical Device R&D Engineer.

Understand the nature, severity, or frequency of suspected problems reported in adverse

  • 23-October-2019| 03:00 PM ET | 12:00 PM PT | 02:00 PM CT Duration 90 Minutes

Corrective and Preventive Action; Your Most Important Process

By: William Levinson ,Principal Consultant at Levinson Productivity.

CAPA is arguably the most important process in a quality management system

  • 20-November-2019| 01:00 PM ET | 10:00 AM PT | 12:00 PM CT Duration 60 Minutes
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