RAPS Florida Chapter: The World of Quality Metrics—Yesterday, Today and Tomorrow

The RAPS Florida Chapter invites you to participate in a 60-minute webcast covering the importance of quality metrics in regulatory, with particular focus on the differences between CDER and CDRH initiatives.

In 2011, CDRH launched “The Case for Quality” initiative in an effort to advance the focus of industry and FDA beyond compliance towards higher assurance of quality. In 2012, the FDA Safety and Innovation Act (FDASIA) was passed by Congress. Since that time, industry has seen CDRH and CDER move in different directions and at a different pace towards end goals that seem similar, but yet unclear. Our featured presenter co-led with FDA the CDRH Metrics Initiative and co-led with PricewaterhouseCoopers the pharmaceutical metrics initiative, and will address the following points:

  • Why there are differences between the CDER and CDRH metrics initiatives
  • The progress of both initiatives
  • The device and pharma metrics—differences and similarities
  • Next steps




  • At a Glance
  • Objectives
  • Speaker
  • Registration Info
  • Cancellation

At a Glance

Date:

Thursday, 27 April 2017 (12:00–1:00 pm EDT) 

Location:

Virtual Event

RAC Credits:

One RAC certification credits upon completion of the program. 

Registration ClosesMonday, 24 April 2017

Registration Fees:

RAPS Members: $20
List: $30

Objectives

At the conclusion of this webcast, you should have a better understanding of:

  • Why there are differences between the CDER and CDRH metrics initiatives
  • The progress of both initiatives
  • The device and pharma metrics—differences and similarities

Speaker

Marla A. Phillips, PhD, director, Xavier Health, Xavier University

Registration Info

RAPS Members: $20
List: $30

>> 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 Contact

Local Contact: Jan G. Flegeau, chair, RAPS Florida Chapter

RAPS Contact: Wesley Carr, senior program manager, chapter and volunteer relations

Cancellation

Registration fees for this event are nonrefundable. Substitutions may be accepted with written approval from RAPS. If you have questions or concerns, please contact RAPS customer service at +1 301 770 2920, ext. 200, or via email at raps@raps.org.