North Texas Chapter: Webinar Replay: Responding to an FDA Inspection

When:  Jun 27, 2018 from 05:30 PM to 08:00 PM (CT)
Associated with  ACRP North Texas Chapter

Webinar Replay: “Responding to an FDA Inspection”

Darshan Kulkarni

Program Agenda:

  • 5:30 – 6:00 pm Registration, Sign-In, Snacks & Networking
  • 6:00 – 7:00 pm Webinar
  • 7:00 – 8:00 pm Highlights of 2018 ACRP Global (no contact hours provided)

Program Description: This webinar is intended to expose the attendee to the basics of an FDA response. It will begin by identifying the core findings in an FDA response and explore considerations in responding to an FDA inspection. The goal of the presentation is for the attendee to recognize, evaluate and respond to the FDA’s inspection without causing an escalation – or understand when it is important to bring in additional assistance.

The “Highlights of ACRP Global” presentation is intended to expose the attendee to topics presented at the 2018 ACRP Global Meeting, April 27-30, 2018, Gaylord National Resort & Convention Center, National Harbor, Maryland

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

  • Identify the main causes of an FDA inspection
  • Identify the primary types of enforcement actions
  • Identify the core team responsible for dealing with an FDA inspection
  • Identify the appropriate and reviewing mechanisms for an FDA inspection

Target Audience: Anyone working in or pursuing a degree in clinical research, including: Clinical Research Coordinators, Clinical Research Associates, Clinical Site Managers, Project Managers and Investigators.

Registration Cost: No fee for attendees who do not want to receive contact hours; however, if you want to obtain contact hours, you must purchase them individually.

Contact hours: 1.0 ACRP contact hour has been approved through ACRP for the webinar only. 

The Association of Clinical Research Professionals (ACRP) provides 1.0 continuing education credits for the completion of this educational activity. These credits can be used to meet the certification maintenance requirement.

To receive contact hours: Purchase the contact hours, sign in at the registration desk, and attend the program. Afterward, log on to the ACRP website then click “My Learning Portal” to complete the evaluation and receive the online certificate. 

Contact Hour Cost:

  • $0 Chapter Members
  • $15 ACRP Members
  • $75 Non-Members

Refund Policy: Not applicable