Data Quality Culture and Building a Corporate Data Integrity Plan


Product Id : FDB3100
Presenter : Heloisa Cytrynbaum
Scheduled On : May 13, 2019 at 10:30 PM (India Time)
Duration : 60 Minutes

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
Purchase Options

1. Live Session, 2. Recording Access, 3. Live & Recording Combo

Presenter Details

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.