May

2001

Update on Part 11 in [Validation Times]

The Validation Times Vol III, No. 5 May 2001 reported that James McCormack of FDA :

1. Indicated that the first two FDA Part 11 Guidances may be issued as early as June 2001. These would be the Glossary and Validation guidances. Scope would not be addressed. Other guidances would follow over a period of months to cover time stamps, archiving, e-copies of electronic records, and audit trails.

2. 26 warning letters with 44 citations issued as of May 21. 13 citations have been issued related to securiity and audit trails, 12 related to validation. 3. Tthe use of hand-held devices and web based systems and the relevance of 21 CFR Part 11 requirements is under discussion at FDA.

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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.

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Instructor: Brian Pate

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Being Agile & Yet Compliant (Public or Private)

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

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Instructors: Mike Russell, Ron Baerg

Next public offering: March 7 & 28, 2024

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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

Update on Part 11 in [Validation Times]

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