Duration: 60 Minutes


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The purpose of the webinar is to bring attendees attention to behaviors and conducts that companies should consider when considering the implementation of a corporate data integrity plan.


Areas Covered in the Session :

Quality Culture to Assure Data Integrity:

  • Falsification vs Bad Practice
  • Cressey’s ‘Fraud Triangle’
  • Managing Behavior
  • Possible Governance Models for Data Integrity

Corporate Data Integrity Plan:

  • Risk-Based Plans and Organizational Structures
  • Quality Management System enhancements
  • Data Life Cycle & GXP Data Governance
  • Metrics and Reporting to SLT

Who Should Attend:

  • Quality Assurance Departments
  • Quality Control Departments
  • Research and Development Departments
  • Regulatory Affairs Departments
  • Manufacturing Departments
  • Production Departments
  • Documentation Departments
  • Site Directors


  • 28 years of experience in GLAXOSMITHKLINE, in management positions at different functional areas as: Production, Quality Systems and Third Party Quality Management, member of GSK Data Integrity corporate program, implementing DI plan in more than 30 sites.
  • Extensive practice in preparing sites for receiving regulatory inspections, such as ANVISA and INVIMA, and preparing corrective and preventive actions post inspection.
  • Considerable experience in conducting due diligences in the Latin America region, aiming to site and product acquisition, as well as product and supplied materials quality audits.
  • Working in a multicultural environment leading and coaching teams in sites located in different regions such as Americas, Europe, Asia and Africa.
  • In depth knowledge of quality system requirements of the main international regulatory agencies like FDA and MHRA.
    Leading high complex projects through multifunctional teams, in challenging environment seeking for immediate results.
  • Expertise implementing and improving quality systems, through developing people by interactive trainings, using real life case studies, in addition to GMP background education in small to large companies.
  • Fast and logical thinking skills, focused on results and problem solving, committed to the company and building relationship strengths.
  • Fluency in English, Portuguese and Spanish.