Ensuring Data Integrity for FDA/EU Compliance 2015

Key Topics

• How FDA inspectors check integrity of data
• Eight key FDA/EU requirements for integrity and security of electronic records
• The importance of limited access to `individual users` rather than to groups
• Most frequent data integrity issues: going through recent 483`s, EIRs and warning letters
• Critical integrity and security issues during the entire life of records
• FDA compliant definition, acquisition, maintenance and archiving of raw data
• Documenting changes of regulated 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
• Required skills and responsibilities of internal and 3rd party consultants?
• Ensuring timely availability of data through validated back-up and archiving
• Going through representative case studies: FDA observations, complete responses to each observation, corrective actions and preventive actions

Who should Attend

Attendees involved or interested in:

• IT managers and staff
• Everybody using computers in FDA regulated environments
• Medical Device Manufacturers
• Manufacturers of drug substances (APIs)
• Clinical contract laboratoriers
• Analytical Contract laboratories
• Quality control directors or delegates
• QA managers and personnel
• Regulatory affairs
• Internal auditors
• Consultants
• Training departments
• Validation specialists