FDA CDER/ORA CPG 7132a.15 Source Code

FDA CDER/ORA Compliance Policy Guide Sec. 425.300 Computerized Drug Processing; Source Code for Process Control Application Programs(CPG 7132a.15) revised 16-April-87. Regards source code and its supporting documentation for application programs used in drug process control to be part of master production and control records, within the meaning of 21 CFR Parts 210 and
211. Accordingly, those sections of the current good manufacturing practice regulations which pertain to master production and control records will be applied to source code. The drug manufacturer therefore is expected to have access to and to review the source code.

SoftwareCPR keywords: software, drugs, pharmaceuticals, validation, supplier, vendor, COTS, OTSS

62304 Software Training Course – February 23-25, 2021

IEC 62304 and Emerging Standards and FDA Expectations for Medical Device and Health IT Software – Virtual

This very popular 3-day course provides a clear understanding of applying IEC 62304 standard for medical device software and much more. The course compares and contrasts 62304 with FDA expectations and discusses approaches for alignment. In addition, participants will learn of other relevant standards and technical reports pertinent to medical device software, HealthIT, medical mobile apps, and Software as a Medical Device (SaMD) products (e.g., 82304, 80002-1, 14971, 80001-2-x, 62366).

Participants will gain practical advice and pragmatic experience with all types of medical software. Participants will leave with a clear understanding of how to effectively and efficiently integrate 62304 compliance into their software development lifecycle (SDLC).

Register (click):  EventZilla Registration Site

Need info?  Email us at training@softwarecpr.com

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