Join your regulatory colleagues from the San Francisco Bay area for the 2014 FDA Pacific Region Update. This popular annual event is sponsored by the RAPS San Francisco Chapter and is intended to foster communication and strengthen the relationship between regulatory professionals and agency representatives. The interactive program will include presentations from senior agency officials, after which attendees engage speakers in interactive question and answer sessions. Presentations include:

Change is the Only Constant–Mark Roh, Pacific Region US FDA
FDA must remain current with advances in science and technology in order to render wise and objective decisions. This continuous evolution of policy and regulation is necessary to advance public health protection. FDA currently is exploring an agency-wide program alignment initiative and a renewed focus on product quality and the overall risk to the patient. This presentation will outline these concepts and potential policy and organizational changes.

How Does Filing an MDR Electronically Impact Your Life?–Judy Strojny, Pacific Region US FDA
In today’s world most everything, including MDRs, has an electronic component. This discussion will explore MDR filing past, present and future, including the criteria for filing. Has guidance changed on what triggers the need to file an MDR with FDA?

Chance Favors the Prepared: Preparing for an FDA Audit–Kay Lewis, San Francisco District US FDA
This presentation will discuss how to prepare for FDA inspections. New regulations in FSMA and FDASIA have dictated that FDA change its processes for regulating industry. Part of that change is moving from the classic inspection to an audit process. Attendees will gain insight into FDA’s thinking on inspections versus audits and that will help them be more prepared for their next audit.

Life After the 483–Steven Porter, Los Angeles District US FDA
This presentation will identify the most common significant inspectional observations and provide case studies to help demarcate the road into compliance.