ACRP Circle City Chapter holding quarterly speaking event March 22, 2011

by | Mar 15, 2011

Please join the Circle City Chapter of Association of Clinical Research Professionals for their upcoming speaking event

TOPIC: FDA Form 483’s & FDA Warning Letters Involving Clinical Drug Trials Issued in 2010:  What We Can Learn

Presented by David Finch, CCRP, Sr. Clinical Site Manager/Sr. CRA III, Quintiles, Inc.

Lecture Description:

The speaker will summarize the major findings and trends in warning letters issued by the FDA during 2010 as well as provide tips for preventing these violations.

DATE:   March 22, 2011

AGENDA:

5:30pm-6:00pm        Registration

6:00pm-6:15pm        Introduction

6:15pm-7:30pm        Lecture

Learning Objectives:                                                                 

  • The attendee will be able to distinguish the difference between FDA form 483 and an FDA Warning Letter
  • The attendee will be able to identify the major reasons FDA Warning Letters were issued in 2010
  • The attendee will gain knowledge to help prevent an FDA citing from occurring in their workplace and/or within their job role.

 Target Audience:

This activity is intended for Principal Investigators, research nurses, study coordinators, clinical research monitors and other clinical research professionals, ACRP members and non-members.

 Location:      Farm Bureau Building, 225 South East Street, Downtown Indianapolis, Assembly Halls C and D

Click here for more information on the ACRP website.

Contact hours have been applied for through ACRP. Membership is not required for online registration/application of contact hours. To receive contact hours, go to “My Tests, Evaluations and Certicates (TEC) record on the ACRP website and complete the evaluation between 10-30 days following the event. CEUs are $10 for ACRP members and $25 for non-ACRP members.