A must attend webinar for those personnel that require an understanding of the FDA's requirements for PMA annual reports.
This webinar describes the information required by FDA to be submitted in a PMA annual report. The webinar also discusses FDA recommendations for leve ...
This web seminar presents an overview of FDA's Adverse Event Reporting Systems for Drugs and Medical Devices. Adverse Event Reporting for Investigational Drugs/Medical Devices and post-approval Adverse Event reporting will be covered. Attendees will receive information about FDA Adverse Event regulations and how to interpret and comply with the various regulations.
This is a must attend webinar for those personnel that require an understanding of the regulations governing FDA's Adverse Event Reporting for Drugs ...
This presentation will cover the scope, status and results of the surveillance inspections and what they may mean for the future of 21 CFR Part 11. At the beginning of the initiative FDA made it very clear that Part 11 is in effect and is enforced according to the original Part 11 and the Guidance from 2003.
In December 2010 the FDA began a project to better understand the industry's adherence (or lack thereof) to 21 CFR Part 11. This involves the add on' ...
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