North Texas: Responding to a FDA Inspection

When:  May 12, 2018 from 8:30 AM to 11:00 AM (CT)
Associated with  ACRP North Texas Chapter

Responding to an FDA Inspection

Click here to view event flyer.

Also… Bridget Gonzalez will share “Highlights of 2018 ACRP Global” 

Bridget Gonzales, CCRC, Director, Training and Professional Development, Association of Clinical Research Professionals

Bridget states that she has no financial interest/arrangement or affiliation with one or more organizations that could be perceived as a real or apparent relationship in the context of the subject of this presentation or in the planning of this educational activity.

Agenda:
  • 8:30-9:00 AM Registration, Sign in, Continental Breakfast and Networking
  • 9:00-10:00 AM Webinar (1.0 contact hour available)
  • 10:00 – 11:00 AM Highlights of 2018 ACRP Global (no contact hours provided)
Program Description (webinar):  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 attended to topics presented at the 2018 ACRP Global Meeting, April 27-30, 2018, Gaylord National Resort & Convention Center, National Harbor, Maryland

Upon Completion of the webinar, participants should be able to:
Identify the main causes of an FDA inspectionIdentify 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.

Costs:  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. The fee is $15 per contact hour for each national ACRP member and $75 for each non-member. CE contact hours are Free for NTX Chapter members or other ACRP Chapter members who are also ACRP members. Contact hours will be available for purchase on your chapter’s website from now until 5/26/18 (2 weeks post meeting). The evaluation will be available on your ACRP records from 5//13/18 – 6/13/18.

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 click “ACRP Learning Portal” to complete the evaluation between 1-30 days following the event and receive the online certificate. 

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 contact hours for the completion of this educational activity with the completion of the online evaluation form. This credit may be used to meet Maintenance of Certification requirements. 

If you do not have a username and password, please use New Visitor Registration to register.ACRP Members, Login with your email address and password (required) to register online.

Please register by Friday, May 11 and check our website for updates.

Sponsor: Scottish Rite Hospital has provided the room for this event.

The sponsor named above does not have any influence on the content of the presentation.

Contact NorthTexas@acrpnet.org with questions or concerns
Click here to view event flyer.

Location

Scottish Rite Hospital
2222 Welborn Street
Dallas, TX 75219
Event Image

Contact

ACRP North Texas Chapter

NorthTexas@acrpnet.org