Course

Preparing for FDA Inspections and Conducting Sponsor Audits

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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.

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

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.