John Avellanet   Managing Director & Principal  Cerulean Associates

John Avellanet
Managing Director & Principal
Cerulean Associates

Has your company implemented the newly-released FDA Data Integrity Guidance? Learn what you need to do by participating in the Data Integrity Master Class, Tuesday, March 12, 2019, from 8am-4pm, at Xavier University. John Avellanet, who has trained regulatory agency officials on advanced inspection tactics for data integrity, will provide the latest information, answers, examples, and steps to take today to reduce risk to your products and patients.

Arrive at 7:30am and enjoy a complimentary warm breakfast before the class starts.

Register today for this very interactive class, which includes:

  • Two full case studies of how firms uncovered their data integrity breaches

  • Exercises where you play the role of the FDA investigator

  • Multiple structured questions throughout

Key Takeaways

  • Highlights of what is new from the FDA Data Integrity Guidance

  • 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


The Data Integrity Master Class, Tuesday, March 12, 2019, from 8am-4pm, is $850 and only $685 when you also register for FDA/Xavier PharmaLink conference. For complete information on planning your trip to the Master Class, click here.

And continue your learning with FDA, industry experts, and your colleagues by registering for the FDA/Xavier PharmaLink conference, starting with the PharmaLink Welcome Reception the evening of March 12 and conference sessions, March 13-15, 2019.

About the Master Class Discussion Leader