MID-SOUTH: Webinar Replay: Responding to an FDA Inspection

Webinar Replay: Responding to an FDA Inspection

Program Description: This presentation 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.

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:

• CRCs
• CRAs
• Clinical Research Administrators

Registration Cost: FREE to all Chapter, ACRP, and non-members

Contact hours: 1.0 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 registration desk, and attend the program. Log on to the ACRP website then “ACRP 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: Intermediate