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.
Learning OutcomesAt the conclusion of the course, you should be able to
- Describe current sponsor and FDA practices expected during inspections.
- Discuss how regulations and guidance are applied to improve inspection readiness.
- Explain the differences between audits and inspections, sponsor responsibilities in relation to the FDA.
- Identify risks in clinical trials that will be issues during a sponsor audit or FDA inspection
- 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
Working knowledge of:
- Communication and collaboration tools such as Google Workspace, Microsoft Office, or LibreOffice
- Learning Management Systems (LMS) such as Canvas including navigation links, modules, etc.
Additional InformationPlease review section notes to view the full schedule.
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.
Professional CreditCA BRN/LVN Credit--Provider #CEP13114.
Have a question about this course?
- Save Your Seat
Help us confirm course scheduling. Enroll at least seven days before your course starts.
- Accessing Canvas
Learn more about gaining access to your course on Canvas in our FAQ section.
Accessibility and Accommodation
For accessibility questions or to request an accommodation, please visit Access for Students with Disabilities or email the Extension registrar.
Finance Your Education
Here are ways to pay for your education.
This course is related to the following programs:
Sections Open for Enrollment:
|Date:||Start Time:||End Time:||Meeting Type:||Location:|
|Fri, 11-17-2023||5:30 p.m.||9:30 p.m.||Live-Online||REMOTE|
|Fri, 12-01-2023||5:30 p.m.||9:30 p.m.||Live-Online||REMOTE|
|Fri, 12-08-2023||5:30 p.m.||9:30 p.m.||Live-Online||REMOTE|
|Fri, 12-15-2023||5:30 p.m.||9:30 p.m.||Live-Online||REMOTE|