Data Integrity Findings, 483 & Warning Letters – What is the FDA looking for?

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On December 2018, the FDA published the Final Guide for Data Integrity in the regulated industry.  But even before that, the FDA has been pounding the industry with findings related to Data Integrity.  All FDA-regulated companies are currently working on Data Integrity and everybody is talking about the topic.  Are we really focusing on the facts we should be focusing? Which observations the FDA has been finding on the audits?


I expect to present & discuss between 12-15 different observations from the FDA to different companies.  The idea is to raise the level of awareness in the attendees so they can help their sites to be in compliance.


Part I – Concepts around Data Integrity Guideline

  • What’s ALCOA and what’s ALCOA+
  • Is Data Integrity something really new in the industry


Part 2 – Findings, Observations, FD-483, Warning Letters

  • Discussions of different Data Integrity Findings
  • Why are those findings related to Data Integrity


Learning Goals

  • Understanding FDA expectations related to Data Integrity
  • To have a flavor of the type of observations that the FDA has been finding during the audits


Top Reasons to Attend:

  1. You will be able to identify the requirements presented in the new FDA Guideline on Data Integrity and how they related to the findings.
  2. The attendees should leave with a better understanding of the FDA expectations on the guideline.
  3. You will be able to understand how the human factor might affect Data Integrity
  4. Attendees will receive information related to FDA Findings on Data Integrity that will be able to use to prevent situations on their respective companies.
  5. The people in the conference will be able to understand the basics findings that should be avoided in order to develop a robust Data Integrity Program
  6. The attendees will be able to take in consideration the human factor when developing their Data Integrity Programs.
  7. To identify some tools for Data and Report Management.
  8. To understand the role of the Senior Management in Data Integrity
  9. To understand the role of each one of us in our sites concerning Data Integrity
  10. To learn how to deal with Data Integrity findings

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Roque Redondo

VP Automation & Business Development, USA Operations at Mirus Consulting Group

Mr. Roque Redondo has close to 30 years of experience including international experience in the pharmaceutical / biotechnology / medical devices industry in the Validation, QA, Engineering / Compliance / Regulatory Areas. He was part of the Sr. Management Team during the implementation of the remediation activities related to Schering-Plough Consent Decree. His experience includes Data Integrity, Operations, Serialization, Validation, QA, Engineering and Technical Services. This professional has attended to over 10 different courses related to Data Integrity as well as he has written 5 articles related to this topic. Mr. Redondo has a nice blend of experience that help him understanding the importance of manufacturing operations without jeopardizing the quality of the products with strong management skills. Finally, Mr. Redondo also has knowledge and experience in Process and Cleaning Validation.