FDA CDER/ORA CPG 7132a.12 Vendor Responsibility

FDA CDER/ORA Compliance Policy Guide Sec. 425.200 “Computerized Drug Processing; Vendor Responsibility” (CPG 7132a.12) revised 4-Sept-87. Establishes end user responsbility for validation/suitability of vendor supplied hardware and software used in Drug manufacturing, holding or processing and identifies conditions under which the vendor may also be liable including if they perform hardware/software maintenance on behalf of the users.

SoftwareCPR keywords: software, drugs, pharmaceuticals, validation, supplier, 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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