Apr

2002

FDA CDER Drug GMP 211.68 Equipment

Attached is the section of the Drug GMP “211.68 Automatic, Mechanical, and Electrical Equipment”.

This section describes basic requirments for computer systems and automated equipment used in the manufacture, processing, packing, and holding of a drug product.

It emphasize input/output verification for data and formulas with the degree and frequency of such checks being based on system complexity and reliability. It also empahsizes backups.

SoftwareCPR keywords: software, drugs, pharmaceuticals, CBER, biologic

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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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Next public offering: Dec 3, 4, & 5, 2024 – 12:00 pm to 5:00 pm CET

IEC 62304 and other emerging standards for Medical Device and HealthIT Software

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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Next public offering: TBD

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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 Drug GMP 211.68 Equipment

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