RAPS DC-Baltimore Chapter: Data Integrity Basics for Regulatory Affairs Professionals

During FDA drug and device inspections, investigators now ask to see the firm’s system that ensures the accuracy and consistency of its data. When firms fail to have a system, or the system is inadequate, FDA officials issue 483 observations send warning letters.

Come engage with colleagues from the local regulatory community and learn how to avoid the pitfalls associated with data integrity. This event is sponsored by the RAPS DC/Baltimore Chapter and is intended to promote knowledge sharing and connections between regulatory and related professionals in our region.

 You should arrive no later than 6:15 to participate in a drawing for special giveaways. A light meal will be provided. RAC holders may claim two RAC recertification credits.




  • At a Glance
  • Objectives & Audience
  • Agenda
  • Speaker
  • Registration Info
  • Cancellation

At a Glance

Date:

Monday, 27 March 2017 (5:30–8:00 pm EDT) 

Location:

RAPS Global Headquarters
5635 Fishers Lane, Suite 550 
Rockville, MD 20852

Directions are available online or by calling +1 301 770 2920 ext. 200. 

RAC Credits:

Two RAC certification credits upon completion of the program

Registration Fees:

Prior to 20 March 2017
RAPS Members: $30
List: $45

On or after 20 March 2017
RAPS Members: $40
List: $55

Objectives

At the conclusion of this program you will have a better understanding of:

  • Why FDA has started to focus on data integrity
  • The relevant regulations and guidance document
  • How FDA assesses data integrity in its review of submissions and during preapproval inspections
  • A case study of a clinical submission, with a focus on how it went wrong

Agenda

Monday, 27 March 2017

5:30–6:30 pm           Registration Check-in, Networking and Dinner

6:30–7:30 pm           Speaker Presentation

7:30–8:00 pm           Questions and Answer Session 

Speaker

John Avellanet, principal and managing director of Cerulean Associates

Registration Info

Prior to 20 March 2017
RAPS Members: $30
List: $45

On or after 20 March 2017
RAPS Members: $40
List: $55

>> Registration Online

>> Registration Form (PDF) – for registration by mail or fax.

Other Information

RAPS reserves the right to cancel this program at its sole discretion. RAPS will not be responsible for travel or other costs incurred due to cancellation.

Questions? Call RAPS Solutions Center at +1 301 770 2920, ext. 200, or email raps@raps.org.

Program Contacts

Local Contacts:
Nancy Singer, JD, RAC, FRAPS, co-chair, RAPS DC/Baltimore Chapter 
Daniela Drago, PhD, co-chair, RAPS DC/Baltimore Chapter
 
RAPS Contact:
Wesley Carr, senior program manager, chapter and volunteer relations, RAPS

 

 

 

Cancellation

RAPS is not able to accept cancellations by phone. All requests for cancellation must be received in writing or by calling customer service. Supporting documentation is required and must be received by the deadline specified. Chapter events with registration fees less than $100 will not be refunded. For events that exceed this amount a 20% cancellation fees will be assessed.

Please send your cancellation information, with documentation, specifying the name of the person registered, customer (or member) number and event title via email, to raps@raps.org

Substitutions may be accepted with written approval from RAPS.