August 3, 2008

Aug

SoftwareCPR Risk Management Training Example 1$

August 3, 2008Brian PateBlog, Prem

This content is only available to Premium and higher subscribers. See our Subscribe page for information on subscriptions. Prepared this example Device Risk Management SOP for the purpose of risk analysis training where the pros and cons could be further discussed. This example is modeled on the approach required by ISO 14971 and expands on it with...

Aug

SoftwareCPR Clinical Trials Validation Manual$

August 3, 2008Alan KusinitzBlog, Prem

This content is only available to Premium and higher subscribers. See our Subscribe page for information on subscriptions. This reference manual includes select FDA documents as well as SoftwareCPR training aides and checklists that SoftwareCPR uses in its training courses on Validation of Clinical Trials Computer Systems. The PDF is over 2 MB so be patient downloading...

Aug

FDA CDRH Rosencrans Submissions Presentation

August 3, 2008Alan KusinitzNews

/docs/FDASubmissionsPresentation2005Rosecrans.pdf

SoftwareCPR Risk Management Training Example 1$

SoftwareCPR Clinical Trials Validation Manual$

FDA CDRH Rosencrans Submissions Presentation

SoftwareCPR Training Courses

Corporate Office

Day

SoftwareCPR Risk Management Training Example 1$

SoftwareCPR Clinical Trials Validation Manual$

FDA CDRH Rosencrans Submissions Presentation

SoftwareCPR Training Courses

Corporate Office