Apr

1987

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

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Being Agile & Yet Compliant (Public)

Our SoftwareCPR unique approach to incorporating agile and lean engineering to your medical device software process training course is now open for registration!

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3 days virtual (Zoom) with group exercises, quizzes, examples, Q&A.

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Our flagship course for preparing regulatory, quality, engineering, operations, and others for the activities and documentation expected for IEC 62304 conformance and for FDA expectations. The goal is to educate on the intent and purpose so that the participants are able to make informed decisions in the future. Focus is not simply what the standard says, but what is meant and discuss examples and approaches one might implement to comply. Special deep discount pricing available to FDA attendees and other regulators.

3-days onsite with group exercises, quizzes, examples, Q&A.

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Medical Device Cybersecurity (Public or Private)

This course takes a deep dive into the US FDA expectations for cybersecurity activities in the product development process with central focus on the cybersecurity risk analysis process. Overall approach will be tied to relevant standards and FDA guidance documentation. The course will follow the ISO 14971:2019 framework for overall structure but utilize IEC 62304, IEC 81001-5-1, and AAMI TIR57 for specific details regarding cybersecurity planning, risk characterization, threat modeling, and control strategies.

2-days onsite with group exercises, quizzes, examples, Q&A.

Instructor: Dr Peter Rech, 2nd instructor (optional)

Next public offering: TBD

FDA CDER/ORA CPG 7132a.15 Source Code

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