Aug 30 2010

FDA Warning Letter – Consent Decree Software Validation : Compliance Training Webinar (Online Seminar) – ComplianceOnline.com

Category: Uncategorizednorm @ 11:29 am

FDA Warning Letter – Consent Decree Software Validation : Compliance Training Webinar (Online Seminar) – ComplianceOnline.com.


Aug 30 2010

FDA Software Validation Self-Check – plan an effective Internal Audit program : Compliance Training Webinar (Online Seminar) – ComplianceOnline.com

Category: Uncategorizednorm @ 11:29 am

FDA Software Validation Self-Check – plan an effective Internal Audit program : Compliance Training Webinar (Online Seminar) – ComplianceOnline.com.


Aug 30 2010

How to reduce software validation project time and use risk management to improve system performance : Compliance Training Webinar (Online Seminar) – ComplianceOnline.com

Category: Uncategorizednorm @ 11:29 am

How to reduce software validation project time and use risk management to improve system performance : Compliance Training Webinar (Online Seminar) – ComplianceOnline.com.


Aug 30 2010

Software validation and 21 CFR Part 11 remediation planning: FDA inspection strategies : Compliance Training Webinar (Online Seminar) – ComplianceOnline.com

Category: Uncategorizednorm @ 11:28 am

Software validation and 21 CFR Part 11 remediation planning: FDA inspection strategies : Compliance Training Webinar (Online Seminar) – ComplianceOnline.com.


Aug 30 2010

Software Validation-Keys to Success and How to Avoid Common Errors : Compliance Training Webinar (Online Seminar) – ComplianceOnline.com

Category: Uncategorizednorm @ 11:28 am

Software Validation-Keys to Success and How to Avoid Common Errors : Compliance Training Webinar (Online Seminar) – ComplianceOnline.com.


Aug 30 2010

’Using the FDA guidance ’General Principles of Software Validation’ to strengthen your firm’s software FDA compliance’ : Compliance Training Webinar Online Seminar – ComplianceOnline.com

Category: Uncategorizednorm @ 11:27 am

’Using the FDA guidance ’General Principles of Software Validation’ to strengthen your firm’s software FDA compliance’ : Compliance Training Webinar Online Seminar – ComplianceOnline.com.


Aug 05 2010

Validate COTS Software in one-third the time : Commercial off-the-shelf (COTS)

Category: Risk Management,Uncategorized @ 1:21 pm

Validate COTS Software in one-third the time : Commercial off-the-shelf (COTS)

Instructor: David Nettleton


Aug 03 2010

Early Warning Signs of IT Failure: The Four Horsemen of Doom

Category: Uncategorizednorm @ 11:36 am
Webinar Registration

Tuesday, August 10, 2010 11:00 AM – 12:30 PM Eastern Time

The mastery of risk distinguishes modern times from the past: By understanding and measuring risks and their consequences, the future was no longer perceived to be a whim of the gods and humans were thereby empowered to transform their world. Despite the fact that IT deals with “modern” technologies, IT project management has a rather poor track record in the mastery of risks. Standish Group reminds us year after year that about 20% of IT projects are cancelled before completion and less than a third are finished on-time and within-budget with expected functionality. If the discussion is limited to larger and therefore riskier projects of 10,000 function points or more, Capers Jones pointes out that the cancellation rate more than doubles. The bankruptcy of $5 billion FoxMeyer Drugs, Hershey’s inability to ship candy before Halloween, the Denver Airport, and perennial failures at FAA are only a few of the glaring examples of the significant impact of failed and troubled IT projects. However, the postmortem examination of IT projects reveals that long before the failure there were significant symptoms or “early warning signs” of trouble. An early warning sign (EWS) is defined as an event or indication that predicts, cautions, or alerts one of possible or impending problems. EWSs provide an indication of manifesting risks and therefore likely future difficulties and failure. Enterprise and project managers need to ask themselves as early as possible whether any ‘red flags’ warrant significant project redirection or termination. This webinar (1) Reports on the results of a study of seasoned IT project managers, academics, and experts that asked them to rank 53 EWS risks identified from IT project management articles in the academic literature, practitioner journals, and by a panel of experienced IT project management experts, in order to identify the most important EWS; (2) Describes four main sources of IT project risk (the Four Horseman of Doom); and (3) Provides practical advice about how to spot EWSs and what to do about them.

Please note that all webinar times are displayed in US Eastern Time.


Jul 21 2010

Spreadsheet Validation: Understanding and satisfying FDA requirements : Compliance Training Webinar (Online Seminar) – ComplianceOnline.com

Category: Uncategorizednorm @ 2:45 pm

Spreadsheet Validation: Understanding and satisfying FDA requirements


Jul 21 2010

ComplianceOnline – Clustered search on Alfonso Fuller

Category: Uncategorized @ 2:43 pm

Alfonso Fuller.


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