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.

Skills Needed

• To be successful in this class all students should have working knowledge of Google’s G Suite or Microsoft Office, proper email etiquette, and essential understanding of Canvas.

Learning Outcomes

At 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

Topics Include

• 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

Notes

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 Credit: CA BRN/LVN Credit--Provider #CEP13114.