Integration of ERP and Legacy FDA-Regulated Systems 2016

Key Topics

• The steps for validating systems, along with the key documentation associated with maintaining the systems in a validated state, while minimizing costs
• The key input and output points that will warrant greater scrutiny as the integrated system is tested and validated
• The additional training that must be provided to business and IT staff involved in the integration process
• How to leverage these practices across all systems by creating a standardized program for integrating FDA-regulated and non-regulated systems
• The communications necessary to maintain all integrated systems in a validated state, as required, as any changes are made to subsystems or components

Who should Attend

• QC/QA Managers and Analysts
• Information Technology Analysts
• Analytical Chemists
• Clinical Data Managers and Scientists
• Lab Managers
• Compliance Managers
• Computer System Validation Specialists
• Automation Analysts
• Business Stakeholders
• GMP Training Specialists
• Consultants in the Life Sciences Industry