Overcoming Data Integrity challenges in Life Sciences 2016

Key Topics

• Data Life Cycle design and controls
• What is Data integrity
• How do you know you have a Data Integrity problem in your company
• Attributes of Data Integrity and how they map to predicate rules
• Roles and responsibilities of different groups in ensuring data integrity
• Elements of a Data Integrity Assurance program
• Validating Data Integrity
• What data integrity SOPs do auditors expect to see during audits and should their contents be

Who should Attend

• Developers of software for use in Life Sciences industry
• Pharmaceutical industry / Medical device industry / Healthcare industry personnel
• Manufacturing personnel, Manufacturing Automation system vendors and system integrators
• Validation service providers, IT service providers
• Laboratory personnel
• Regulatory Affairs group, Quality Unit
• Clinical Trial Sponsors
• Users of Cloud