Webinar On U.S. FDA's Strategic Priorities - 2015 and Beyond
January 21, 2015 - Mississauga ON CACompliance Trainings
uttam@compliancetrainings.com
Phone:4169154458
This webinar will discuss about two “Strategic Priorities” that the FDA has published to emphasize their future directions vis a vis regulated industry and public safety. This webinar will trigger such a response by an examination / review of FDA's stated concerns for corporate cGMP compliance and public safety. Areas Covered in the Session : Major “Drivers” and New U.S. FDA Initiatives The FDA’s “Strategic Priorities” (1): 2011 – 2014 The FDA’s “Strategic Priorities” (2): 2014 – 2018 Major foreseeable problem areas for 2015 and beyond Device, Pharmaceutical, Biological and Combination Products Issues cGMP Issues - Strengthened Compliance The Global Supply Chain FDA's Life Cycle Requirements Navigating through "Better Science" A company gap analysis vis a vis FDA priorities Correcting problem-prone areas Interactive Q & A session Who Will Benefit: This webinar will provide valuable assistance to all U. S. FDA-regulated companies. It will assist in their reviewing and modifying their regulatory compliance stance in view of the areas the FDA indicates are of growing / future interest / emphasis. Its principles apply to personnel / companies in the Medical Devices, Pharmaceutical, Diagnostic, and Biologics fields. The employees who will benefit include: Research & Development Engineering Staff Software Department Quality Assurance Regulatory Affairs Manufacturing Operations cGMP instructors Consultants Mid-level and Senior Management Personnel involved in verification and/or validation Personnel involved in planning, execution and documentation