Did you know that 5 of the top 7 FDA risk enforcement priorities involve your senior management team?

Learn how your senior management team can management FDA compliance effectively with just 48 hours per year. Discover 14 typical FDA auditor questions regarding quality systems management, top 7 FDA risk enforcement priorities. Learn six do’s and seven don’ts on effective quality management oversight.

What You Will Learn:

  • How effective compliance senior management oversight takes just 48 HOURS PER YEAR
  • The average cost per person (in thousands of dollars) for effective quality management oversight (less than this is an FDA red flag)
  • 14 typical FDA auditor questions regarding your quality systems management
  • Top 7 FDA risk enforcement priorities (5 involve your senior management team)
  • The huge costs of a consent decree ($300 mil+ average) vs. effective quality management ($500k average)
  • Huge costs of a post-warning letter clean up ($480k average) vs. mock FDA audit ($14K average)
  • 6 do’s and 7 don’ts on effective quality management oversight
  • What the FDA expects of senior management when it comes to the quality system and compliance infrastructure oversight
  • Five crucial challenges to overcome to avoid FDA enforcement action
  • How the inspector will determine if a quality system is being managed effectively
  • What will prompt FDA to publicly name you … and how to avoid it
  • Seven steps to take every year to prove effective oversight of SOPs and policies
  • How to ethically limit your personal exposure as an officer of the company

You will receive ICH Q10 guidance with emphasis on management accountability, FDA warning letter samples that cite poor executive oversight, and OIG’s compliance program guidance for executives.

Attendees will receive these free gifts:

  • Slides that you can print out and share
  • 3-month subscription to FDA Digest – 483/warning letter e-newsletter
  • Complimentary downloadable recording of the event
  • 3-month subscription to SMARTERCOMPLIANCE™ newsletter by Cerulean Associates ($129 value)
  • Expert, easy-to-grasp guide on Quality-by-Design, (QBD) by Cerulean Associates
  • “Lean Compliance for Midsized Companies” (from Journal of GXP Compliance, January 2008)

About the Speaker

John Avellanet, author of Get to Market Now! Turn FDA Compliance into a Competitive Edge in the Era of Personalized Medicine (Logos Press), is the founder and managing director of Cerulean Associates LLC. His clients include Fortune 50 biopharmaceutical firms, medical device startups, and everything in between.