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Course

Preparing for FDA Inspections and Conducting Sponsor Audits | CTDM.X414

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.


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This course is related to the following programs:

Prerequisite(s):

Good Clinical Practices

Sections Open for Enrollment:

Open Sections and Schedule
Start / End Date Units Cost Instructor
10-29-2021 to 11-19-2021 1.5 $625

Jeaneen C Wallis

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Schedule

Date: Start Time: End Time: Meeting Type: Location:
Fri, 10-29-2021 5:30 p.m. 9:30 p.m. Classroom SANTA CLARA
Fri, 11-05-2021 5:30 p.m. 9:30 p.m. Classroom SANTA CLARA
Fri, 11-12-2021 5:30 p.m. 9:30 p.m. Classroom SANTA CLARA
Fri, 11-19-2021 5:30 p.m. 9:30 p.m. Classroom SANTA CLARA