FDA Process Analytic Technology Presentation

The FDA slides at the link provided describe the history and intent of PAT. This approach involves in-process continuous monitoring of manufacturing processes and validation of these systems to allow dynamic feedback rather than static settings.:

SoftwareCPR Training Courses:

IEC 62304 and other Emerging Standards Impacting Medical Device Software

Being Agile & Yet Compliant

ISO 14971 SaMD Risk Management

Software Risk Management

Medical Device Cybersecurity

Software Verification

IEC 62366 Usability Process and Documentation

Or just email training@softwarecpr.com for more info.

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