Safety Critical Software - Software Risk Management Using IEC62304 as the internationally recognized software lifecycle standard the risk dependent activities and documentation requirements will be explained. Live
Tuesday,
February 7, 2012
10:00 AM PST | 01:00 PM EST,
Duration:60 Minutes
Product Risk Management Under ISO 14971 and FDA-ICH Q9 Expectations for meaningful hazard analysis, hazardous conditions, and documentation have always existed by regulatory agencies. Live
Wednesday,
February 8, 2012
10:00 AM PST | 01:00 PM EST ,
Duration:90 Minutes
Supply Chain Risk Management For the last decade, there has been an extensive and organized effort by organizations to assess their risks, especially in financial services. Non Financial firms are now increasing their risk management especially in the light of such complex, global, and out sourced supply chains. The new ISO 31000 and ISO 31010 frameworks provide guidelines in this process that make good sense and build on years of work by risk professionals. Live
Thursday,
February 9, 2012
10:00 AM PST | 01:00 PM EST,
Duration:90 Minutes
This webinar will examine the existing and proposed requirements for the FDA's DHF - including its derivative documents, the DMR and DHR. Recorded
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Duration:90 Minutes
This interactive webinar provides explicit details and live demonstration followed by a collaborative workshop that explains how to configure and validate a GxP compliant spreadsheet application. Recorded
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Duration:75 Minutes
The FDA QSR and the Medical Device Directive specify certain documents or records that should be included in your organization's quality systems - Design History File (DHF), the Device Master Record (DMR) the Device History Record (DHR), and the Technical File (TF). Recorded
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Duration:60 Minutes
When validated methods are transferred between laboratories and sites, their validated state should be maintained to ensure the same reliable results in the receiving laboratory. Recorded
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Duration:75 Minutes