Preparing for FDA Inspection
Available by live attendance or simulcast attendance (via webinar)
Click here for event flyer
Speakers:
Elizabeth Galgocy, RN, MEd, CIP; Compliance Specialist - Manager, Research Quality Assurance, Pennsylvania State University, College of Medicine
Program Agenda:
Program Description: The FDA conducts clinical site inspections to ensure the protection of the rights, safety, and welfare of human research subjects involved in FDA-regulated clinical trials, to verify the accuracy and reliability of clinical trial data submitted to FDA in support of research or marketing applications, and to assess compliance with statutory requirements and FDA's regulations governing the conduct of clinical trials.
These inspections can occur for cause or as part of market approval application submission. Because an FDA inspection can occur with little to no warning, a study site needs to be inspection ready.
Upon completion of this Seminar, attendees should be able to:
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Discuss audit readiness: preparing for a site inspection
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Describe inspectional processes and Investigator responsibilities
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Discuss approach to responding to verbal and written findings
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.
Live Attendance Registration:
- $10 Chapter Members
- $12 ACRP Members
- $15 Non-Members
Simulcast Attendance Registration:
(link will be emailed out on the day of the event)
- $0 Chapter Members
- $5 ACRP Members
- $10 Non-Members
Contact hours: 1.5 Contact hours have been applied for through ACRP.
Membership is not required for online registration of contact hours.
To receive contact hours: Purchase the contact hours, sign in at the event, and attend the program. Log on to the ACRP website then “My Learning Portal” to complete the evaluation no later than 30 days following the event and obtain the online certificate.
Contact Hour Cost:
- $0 Chapter Members
- $15 ACRP Members
- $30 Non-Members
Refund Policy: Not applicable
Level: Beginner / Intermediate
Further Information: CNEPA@acrpnet.org or
Kevin Gardner kgardner@pennstatehealth.psu.edu