Ensuring Integrity and Security of Electronic Records for FDA Compliance 2012

Topics

• How FDA inspectors check integrity and security of data
• Eight key FDA/EU requirements for integrity and security of electronic data
• The importance of limited access to `individual users` rather than to groups
• Most frequent security and integrity issues: going through recent 483`s, EIRs and warning letters?
• Critical integrity and security issues during the entire life of data: from data acquisition through evaluation to archiving
• FDA compliant definition, acquisition, maintenance and archiving of raw data
• Documenting changes of data: paper, hybrid systems, electronic
• Examples how to ensure and document data integrity
• Review of electronic audit trail: who, what, when and how
• The importance of electronic audit trail to document data integrity
• Going through representative 10 case studies: FDA observations, complete responses to each observation, corrective actions and preventive actions
• Ensuring timely availability through validated back-up and archiving

Who should Attend

• QA Managers and Personnel
• IT Managers and System Administrators
• Regulatory Affairs
• QC and Lab Managers
• Documentation Department
• Training Departments
• Consultants