FDA Expectations of Senior Management - Quality System Oversight

$349.00

Summary

FDA is increasingly naming executives for failure to ensure an effective quality system, failure to ensure SOPs are being followed, and failure to enforce policies and procedures.  Under FDAAA 2007, the agency has the power to levy civil penalties on individual executives, withhold approval of new drugs and devices, and even ban company officers from doing business in the industry – bans that have been upheld in court.

Learning points

  • The 12 specific FDA expectations of senior management when it comes to quality system and compliance infrastructure oversight
  • Example inspector questions used to verify good management oversight
  • Cost analyses
  • Six practical challenges faced by industry executives
  • 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 quality systems
  • Examples of SOP components for recalls, supplier oversight and CAPAs that show FDA you “get it”
  • The critical role played by good records retention policies in proving effective oversight and minimizing liability
  • What to look for … and why … in mock FDA audits and gap analyses
  • How to ethically limit your personal exposure as an officer of the company or as a senior manager

And much, much more

Get 10+ documents for easy & quick implementation

  • Sychronized audio-visual recording
  • Slides with room for your own notes
  • Customizable training certificate
  • FDA presentation on management responsibility:  David Jaworski, Management Responsibility – An FDA Perspective
  • Office of Inspector General’s compliance program guidance for pharma firms
  • Office of Inspector General’s compliance program guidance for device executives
  • Office of Inspector General’s compliance program guidance for clinical labs
  • ICH Q10 guidance with its emphasis on management accountabilities
  • FDA FAQ on ICH guidance for managers
  • Eight recent FDA warning letters citing poor executive oversight

And more

How it works

Either purchase the recorded seminar in an immediately available digital download format or request an invoice and the CD shipped to you within 10 business days.

Note:  CD will be shipped after payment has been received.  See our Better Business Bureau-accredited online purchasing and return policy for questions.

More benefits

  • Efficiency:  Elimination of travel means more affordable advice
  • Productivity:  Rely on technology tools to view the recorded seminar and get the reference materials
  • Veteran expertise:  Complement the seminar with a confidential teleconsulting session for further questions specific to your situation
  • Environmentally sound:  Spare our environment with less travel and a digital download

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