Data Quality Culture and Building a Corporate Data Integrity Plan

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

FDB3100

Heloisa Cytrynbaum

Heloisa Cytrynbaum

  • 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.

membership
  Go PRIME   🛈 $ 240 SELECT
  Personal Plan 🛈 $ 3000 SELECT
  Business Plan 🛈 $ 9000 SELECT


  • Login Information with Password to join the session, 24 hours prior to the webinar
  • Presentation Handout in .pdf format
  • Presentation from the Speaker
  • Feedback form
  • Certificate of Attendance
  • Recording access Information with Password to view the webinar, will be sent 24 hours after the completion of the Live webinar.
  • Presentation Handout in .pdf format
  • Certificate of Attendance