Joint Chapter Event: FDA Inspections

Suncoast, Atlanta, Baltimore-Washington, Canada, Chicagoland, Greater New England, Greater Salt Lake, Greater San Diego, Gulf States, Houston, Nashville, Nevada, Northern California, North Texas, Phoenix, Research Triangle, Suncoast, Tulsa, Virginia, Western New York, and Wisconsin Chapters

Speakers:
Wendy Duncan, B.S.N., RN, CIP, CCRA; Interim Associate Director, Research Integrity & Compliance; University of South Florida

Thanh Tran, Director of Surgery department; University of South Florida

Jessica Shaw, MPH, CCRC; Sr. Clinical Research Associate | Research Manager; Neuromuscular Research Division | University of South Florida

Amber McPherson; USF: Senior Clinical Research Associate; Neuromuscular Division

Sandra Sanchez, RN, BSN, CCRP, CCRC; Clinical Research Supervisor; Tampa General Hospital

Program Agenda:

• 12:00pm- 1:00pm 
  • Brief overview of ACRP Chapters
    • Introduce the topic: Getting the Most out of Your SIV
    • Share the comments of this topic
    • Background, Regulatory/GCP, considerations, take-aways

Program Description: 
Overall review of FDA inspection conduct from start to finish. Will include past FDA inspection experience.

Upon completion of this Seminar, attendees should be able to:

1. Demonstrate awareness of varying perspectives of this topic.
2. Apply knowledge to one’s own unique research environment.
3. Demonstrate awareness of some basic regulations or GCP behind this topic

• CRCs
• CRAs
• Investigators
• Auditors
• Project Managers
• Regulatory Affairs/Compliance
• Data Managers (Site, Sponsor, CRO)
• Medical Monitor, Medical Officer, Project Physician
• Quality Assurance
• Clinical Research Administrators

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. Click here to purchase contact hours.

Contact Hour Cost:

• $0 Chapter Members
• $15 ACRP Members
• $30 Non-Members

Refund Policy: Not applicable

Level: Basic to Intermediate