Data Integrity Master Class

Learn from the Expert who Trains the FDA

John Avellanet Managing Director & Principal Cerulean Associates

John Avellanet
Managing Director & Principal
Cerulean Associates

Join us the day before the FDA/Xavier PharmaLink conference, for the Data Integrity Master Class, Tuesday, March 13, 2018, from 8am-4pm, at Xavier University. John Avellanet, who trains the FDA on how to find data integrity issues in companies worldwide, will provide answers, examples and steps to take today to reduce your risk to your company products and patient.

Register today for this very interactive class, which includes:

  • Two full case studies – including of a firm that had previously passed nine different inspections since 2000
  • Exercises where you play the role of the FDA investigator
  • Multiple structured questions throughout
     

Key Takeaways

  • Specific regulatory citations and requirements, and critical guidance documents to master
  • Example FDA inspection questions to prepare for around data integrity
  • How FDA holds you accountable for your suppliers' data integrity during an inspection
  • Eight practical elements of a compliant, risk-based data integrity program
  • The key roles of senior management, IT, records management, and quality
  • Specific SOPs and policies you need, or will need, to improve to meet the latest expectations
  • Rapid techniques to incorporate risk-based decisions and priorities into your overall plan in a way that will pass inspection
  • Specific data integrity-related documents you must have available for regulators
     
Attendees will be able to identify their data integrity gaps without an inspection by FDA or other regulators.
— John Avallenet

Analyze with John:

  • 10 FDA guidance documents on data integrity
  • 11 different FDA presentations on data integrity
  • 14 other regulatory health agency guidance documents on data integrity
  • 1 sample SOP
  • 1 sample policy
  • 4 sample checklists
  • 1 sample quick guide
     

Logistics

For complete information on planning your trip to the Data Integrity Master Class, click here.

And continue your learning with FDA, industry experts, and your colleagues at the FDA/Xavier PharmaLink conference, March 13-16, 2018.


About the Master Class Discussion Leader