Tag

part11
/docs/ASQBiomedicalDivisionPart11comments.PDF
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The Drug GMPs explicitly require signatures in the following places: 211.186 master prod & control recs 211.182 Equipment cleaning & use logs 211.188 batch prod & control recs 211.194 laboratory recs (perform & review) Policy guides and enforcements practices indicate that by interpertation FDA expects signatures on specific records and procedures including any places where...
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Solvay Pharmaceuticals 6/23/99 Computer System Validation 1. The xxxx computer system, used to monitor and maintain such critical systems as the xxxx and xxxx systems, has not been validated. Our inspection revealed that the xxxx computer system is used to monitor temperature, conductivity, water pressure and time (in hours) for replacement of xxxx for the...
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/Docs/FDApresentationonPart11ANDClinicalTrialsSW.pdf
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Multidata Systems Intl. Corp. 7/16/98 Decision Support Systems (DSS) for Radiation Support device 1. Failure of management with executive responsibility to appoint a member of management to establish authority over and responsibility for (a) ensuring that quality system requirements are effectively established and effectively maintained, and (b) reporting on the performance of the quality system...
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SoftwareCPR Training Courses:

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.

Instructor: Brian Pate

Next public offering:  TBD

Email training@softwarecpr.com to request a special pre-registration discount.  Limited number of pre-registration coupons.

Registration Link:

TBD

 


 

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!

  • Agile principles that align well with medical
  • Backlog management
  • Agile risk management
  • Incremental and iterative software development lifecycle management
  •  Frequent release management
  • And more!

2-days onsite (4 days virtual) with group exercises, quizzes, examples, Q&A.

Instructors: Mike Russell, Ron Baerg

Next public offering: March 7 & 28, 2024

Virtual via Zoom

Registration Link:

Register Now

 


 

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

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