Webinar ID:   ICT111

Data Integrity and Human Error

 
ON-DEMAND
  60 Minutes

Categories:   Uncategorised,

Regulators are paying increasing attention to manufacturers’ handling of data, calling out those whose practices are incorrect, incomplete or downright fraudulent. Regulators do not distinguish between human error, sloppiness or data falsification. In this webinar we will look at the reasons humans err whether intentional or unintentional, how companies get affected due to data integrity issues arising out of human errors and the way out.

Areas Covered in the Session :

  • What is Human Error?
  • How Can Human Error Become a Data Integrity Issue?
  • Regulatory outlook
  • Root cause overview
  • Consequences of Compromised Data Integrity
  • Cultural Problems in Data Integrity on the Shop Floor
  • Methodology for Prevention of Human errors

Who Should Attend:

  • Quality Departments
  • Compliance Departments
  • Production Departments
  • Warehouse / Material Management Personnel
  • HR Personnel
  • Regulatory Affairs Departments
  • Engineering Departments
  • Operations Departments
  • Research and Development Departments
  • Documentation Departments

ICT111

Sophia Lily

Sophia Lily has over twenty-five years’ experience in Quality Assurance and Regulatory Compliance in Pharmaceutical, Nutraceutical and Food industries in implementation, sustenance and remediation of Quality systems in line with current regulatory expectations. Her broad knowledge includes serving in Quality Management for established pharmaceutical companies.

She has number of years of hands on experience in Quality System Management, Data integrity requirements, Data security requirements auditing, source inspection and identifying areas for improvement in operations, processes and communications within a context of regulatory compliance.

Her extensive experience in Quality/Compliance management enables her to assist manufacturers in meeting the most current regulatory expectations.