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


Tuesday, September 20 | 11:00AM ET 

Presented by Roque Redondo, Senior Technical Consultant, CSV, PharmEng Technology

In 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.

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:

  • Identify the requirements presented FDA’s Guidance on Data Integrity and how they related to the findings
  • Gain a better understanding of the FDA expectations on the guideline
  • Understand how the human factor might affect Data Integrity
  • Receive information related to FDA Findings on Data Integrity that will be able to use to prevent situations on their respective companies
  • Understand the basics findings that should be avoided to develop a robust Data Integrity program
  • Consider the human factor when developing their Data Integrity programs
  • Identify some tools for data and report management
  • To understand the role of the Senior Management in Data Integrity

SPEAKERS


Roque Redondo

Senior Technical Consultant, CSV, PharmEng Technology


Mr. Roque Redondo has close to 30 years of experience including international experience in the validation, QA, engineering, compliance and regulatory affairs in the life science environment. He was part of the senior 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. Mr. Redondo has attended to over 10 different courses related to Data Integrity as well as he has written 5 articles related to this topic. He has a nice blend of experience, including process and cleaning procedures, that help him understand the importance of manufacturing operations without jeopardizing the quality of the products with strong management skills.


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