FDA Drug & Biologics Data Integrity Draft guidance

FDA issued a draft guidance for Drugs and Biologics titled: Data Integrity and Compliance With CGMP. While s number of the concepts are conceptually relevant to device manufacturers one must be careful with interpretation since the requirements in this guidance are specifically related to elements of the Drug CGMPs and these are not identical to the requirements of Device CGMPs in 21 CFR 820 and related regualtions.

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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