AssurX has been in the business of configuring and implementing Enterprise Quality Management Solutions for two decades, and over that time, it has been a consistent finding that audit management [...]
Blog Home TAG: Audits
In Medical Device Industry, FDA Regulated Industries, Pharmaceutical Industry, Regulatory Compliance ManagementPosted
For FY 2016, FDA is requesting $4.9 billion to support our essential functions and priority needs, which is $425 million above the FY 2015 enacted level. Of the total funding, $2.7 billion is [...]
The FDA says IRB’s (Investigational Review Boards) are not required to collect a statement of investigator assurance from studies they preside over. This is troubling. My first question would be [...]
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