Method
Flexible
Term
SUMMER
Units
1.5 QUARTER UNITS
Cost
$625
Course Description
Formerly: Preparing for FDA Inspections and Conducting Sponsor Audits - GxP
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.
Topics
- Investigator and sponsor/monitor inspections
- How and when inspections occur
- FDA inspection procedures and practices
- Conducting sponsor audits and inspections
- Interacting professionally with inspectors
- Responding effectively to inspectors' observations
Additional Information
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.
AI* - This course examines AI topics as they relate to inspection readiness tools, risk management and central monitoring.
Professional Credit
UCSC EXTENSION Approved by the California Board of Registered Nursing, Provider Number 13114, for 15 contact hours
Prerequisites / Skills Needed
Prerequisites:
- CTDM.X411: Good Clinical Practices
You may enroll in this offering at any time.
Jul. 22 - Aug. 19, Wed, 6:30pm - 9:30pm
- Flexible Attend in person or via Zoom at scheduled times.
CTDM.X414.(16)
Schedule
| Date | Start Time | End Time | Meeting Type | Location |
|---|---|---|---|---|
| Wed, 07-22-2026 | 6:30pm | 9:30pm | Flexible | SANTA CLARA / REMOTE |
| Wed, 07-29-2026 | 6:30pm | 9:30pm | Flexible | SANTA CLARA / REMOTE |
| Wed, 08-05-2026 | 6:30pm | 9:30pm | Flexible | SANTA CLARA / REMOTE |
| Wed, 08-12-2026 | 6:30pm | 9:30pm | Flexible | SANTA CLARA / REMOTE |
| Wed, 08-19-2026 | 6:30pm | 9:30pm | Flexible | SANTA CLARA / REMOTE |
This class meets simultaneously in a classroom and remotely via Zoom. Students are expected to attend and participate in the course, either in-person or remotely, during the days and times that are specified on the course schedule. Students attending remotely are also strongly encouraged to have their cameras on to get the most out of the remote learning experience. Students attending the class in-person are expected to bring a laptop to each 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.
|| Prerequisites:
Prerequisites / Skills Needed
This course applies to these programs:
