Live webinar onU.S. FDA's Strategic Priorities - 2014 and Beyond by Compliance2go

14 January 2014, Houston, United States

Introduction

This webinar will examine the U.S. FDA's annual "Strategic Priorities" initiative, with emphasis on 2014 and beyond. It will focus on the broad range of issues a company's senior management and QA/RA staff need to consider in their annual Management Review of their existing quality management system. Such a mandated review is all the more urgent due to the stated intent of the Agency to get tougher across the board in its expectations for the medical industry and what the FDA and industry need to do internally. Further evaluation of recent information from the Agency, other goals of the Agency that have already been translated into action in the past year will provide direction in areas of concern and what to expect in the future. This will be performed by a review of applicable FDA "Strategic Priorities" areas for required review or related industry problem areas. Major 510(k) changes will be discussed, as will the new combination products CFRs and pharma requirements.