Learn the basics of what makes a corrective and preventative action (CAPA) plan. Webinar Replay expires December 6, 2019.
This session will overview writing for clinical research journals and is designed to empower clinical research professionals to contribute to the evidence and best practices within the industry. Webinar Replay expires December 5, 2019.
Do you understand the process, forms and expectations following an FDA Inspection? We will review the documents exchanged during an inspection and the process followed by FDA to determine whether a warning letter will be issued. Webinar Replay expires November 14, 2019
This session will cover adverse event (AE) reporting for medical device clinical trials, including the following topics: the differences between pharmaceutical and device AE reporting requirements, how to understand the AE reporting requirements for device trials based on a study protocol, and a discussion on device AE reporting requirements from a monitoring and auditing mindset. Webinar replay expires on November 13, 2019.
The session will discuss the privacy and information security concerns that can occur from the time a protocol is drafted through the completion of the study. Webinar Replay expires November 8, 2019.