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Clinical Regulatory Compliance Training & Best Practices
Learn Clinical compliance best practices through expert training / webinar programs to meet the Clinical regulations. This section constitutes clinical compliance trainings, regulatory standards, best practices and news.
Featured Trainings
Compliance Trainings in Oct.
 
The ICF Process: Tips on Achieving Optimal compliance and Comprehension

Instructor : Kimberly Kiner Live Wednesday, September 22, 2010 | 10:00 AM PDT | 01:00 PM EDT

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What are the “Good Clinical Practices” (GCP) of Research involving Human Subjects

Instructor : Charles H Pierce Live Tuesday, September 21, 2010 | 10:00 AM PDT | 01:00 PM EDT

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Data Monitoring Committees (DMCs) effect on subject safety in clinical research and how to set it up to be effective

Instructor : Charles H Pierce Live Tuesday, October 12, 2010 | 10:00 AM PDT | 01:00 PM EDT

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The FDA Tripod - Clinical Trial Regulations, Compliance and GCP in Drug Development

Instructor : Sandy Rizk Soliman Live Tuesday, October 5, 2010 | 10:00 AM PDT | 01:00 PM EDT

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Data Monitoring Committees (DMCs) effect on subject safety in clinical research and how to set it up to be effective

Instructor : Charles H Pierce Live Tuesday, October 12, 2010 | 10:00 AM PDT | 01:00 PM EDT

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Clinical Trial Regulations and GCP Compliance as they relate to Adverse Events - How to Assess and report AEs and SAEs

Instructor : Charles H Pierce Live Tuesday, October 19, 2010 | 10:00 AM PDT | 01:00 PM EDT

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Article of this Week
How to purchase COTS software

Software has become part of almost every business process and the scope and complexity of software is increasing every year. Most software is purchased from a vendor and is referred to as commercial off-the-shelf software (COTS). The term “developer” identifies people that create software and for the purposes of this article is equivalent to the vendor. The term “user” identifies people that use software to perform their job.

The developer and users share responsibilities that affect the quality of the software. The developer must create the software to contain the functionality required by the users, and perform developer validation. The users must perform user validation of the software in the context of its application, meaning the business processes that use the software.  Additionally, the user must ensure proper maintenance and control of the software on an ongoing basis.

The requirements of validation from the developer and user perspectives have many steps in common but the focus of each step is different because their perspectives are different. 

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Compliance Best Practices
Clinical Compliance
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Compliance News
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Compliance Standards
Validation Master Plan
Price: $90
Method Validation
Price: $79
QVD Protocol and Report Preparation
Price: $99
Monitoring of Clinical Trials
Price: $29
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