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Julio C. Lebrón Morales

Julio C. Lebrón Morales has 20+ years regulated environment experience with specialized interest in QC Laboratory Quality System, Computerized Validation Life Cycle deliverables and Quality Systems Instructor.  Julio C. was involved in remediation activities within Warning Letter and Consent Decree status specifically in Computer System Validation program.  Experience extended to implementation and remediation of Data Integrity Program within QC environment.  Julio C. holds a bachelor degree in Chemistry and course a Master Degree in Information Technology Open Systems. 

Mr. Lebrón is trained by Monica Cahilly in the following Data Integrity advanced concepts:

  • Level 1 – Data Integrity Assurance & Investigations of Electronic Data & Computerized Systems: Current Perspective for US FDA Compliance
  • Level 2 – Data Integrity Governance Programs – Advanced Topics & Train-the Trainer: Current Perspective for US FDA Compliance
  • Level 3 – Critical Thinking & Advance Auditing for Data Integrity

Data Integrity Workshops were presented to Food and Drug Administration (FDA) on 2016 and 2017 at ORA University, Rockville, Maryland.

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