So You Have Been Chosen for an FDA Inspection: Guidance from a Former Auditor on How to Prepare, Host and Follow Up for a Site Inspection
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Program Agenda:
- 4:45 pm – 5:00pm – Registration & Dinner
- 5:00pm – 6:30 pm – Educational Presentation and Discussion
Program Description:Join us for a presentation (webinar replay) and discussion that will review the process of an FDA inspection at the site level. The session will discuss how the site and sponsor should work together in the process. Including identifying key players and their roles and responsibilities. During this session, participants will discuss the entire process from start to end from a site's prospective. This session will discuss what the site should review and prepare prior to the inspection, including pointers on how to host the inspection and what do at the end of each day. The session will also discuss what actions are needed after the inspection for follow up.
Upon completion of this Webinar, attendees should be able to:
- Identify key points for preparing for and hosting an FDA inspection of a site and follow up to an inspection.
- Identify key points in working collaboratively with sponsor or designee during the process.
- Identify common areas of deficiencies seen in site audits/inspection and implement improvements to the site’s quality assurance.
Target Audience: Investigators, Clinical Research Staff and Administrators, Clinical Research Coordinators, Clinical Research Associates, Clinical Project Managers, Human Subject Protection Office personnel, Research Quality Assurance staff and anyone working in clinical research.
Further Information: Kevin Gardner
kgardner@pennstatehealth.psu.edu.