Master sponsor audits and FDA inspection readiness in clinical research.
In the regulated pharmaceutical and biotech medical device industries, inspections by government agencies are often a prerequisite for new product-marketing approvals. Knowing what to expect and how to prepare for and respond to such inspections is as critical as conducting sound clinical research. As the FDA and other regulatory authorities increase the frequency of inspections, it is imperative that everyone involved in the development of new therapies be familiar with government inspection processes and their role during these inspections. This course helps participants prepare for FDA inspections and conduct sponsor audits considering GxP guidance.
This course benefits professionals involved in all aspects of clinical research including sponsor clinical development personnel, quality assurance and compliance, investigators, monitors, regulatory affairs personnel, data managers, and safety surveillance personnel
UCSC EXTENSION Approved by the California Board of Registered Nursing, Provider Number 13114, for 15 contact hours
This class is offered in an online synchronous format. Students are expected to log into this course via Canvas at the start time of scheduled meetings and participate via Zoom, for the duration of each scheduled class meeting.
To see all meeting dates, click “Full Schedule” below.
You will be granted access in Canvas to your course site and course materials approximately 24 hours prior to the published start date of the course.
