Central Texas: So You Have Been Chosen for an FDA Inspection

Thursday, February 23, 2017, 6:30 PM - 8:30 PM (UTC-6:00) Central Time (US & Canada)

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


Speaker:
Chavon Steele, MBA, CCRC

Program Agenda:
  • 6:30 pm – 6:45 pm - Welcome
  • 6:45 pm – 7:45 pm - Presentation
  • 7:45 pm – 8:30 pm - Q&A/Closing

Program Description: This session will review the process of an FDA inspection at a site level. The session will discuss how the site and sponsor/or designee should work together in the process. This session will discuss what site should review and prepare prior to the inspection. 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; hosting an FDA inspection of a site and follow up to an inspection.
  • Identify common areas of deficiencies seen in site audits/inspection.
  • Take learning’s from presentation and implement improvements to the site’s quality assurance.

Target Audience: Clinical Research Coordinators, Clinical Research Associates, Clinical Project Managers, and anyone working in clinical research

Contact hours: 1 Contact hour has 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:
No refunds will be given for contact hours purchased. Last date to apply for contact hour credit will be up to 7 days following the event.

Further Information: Please send RSVP to centexacrp@gmail.com by Wednesday, February 15, 2017.

Click here to view event flyer. 

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