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
Course Director: 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.