Evolving Regulatory Expectations for Data Integrity in GMP laboratory 2016

Topics

• What are the consequences of not meeting regulatory expectations for Data Integrity
• What are the new and evolving regulatory expectations
• How are the regulatory requirements evolving for electronic data generated in the laboratory
• Common pitfalls observed during generation, review and archiving data
• What are the systems required to support Data Integrity
• What are the new auditing requirements for Data Integrity

Who should Attend

Attendees from:

• QC chemists, supervisors and managers
• IT Department personnel responsible for lab data
• QA Managers and personnel
• R&D chemists, supervisors and managers
• Regulatory Affairs personnel