Data Integrity: FDA/EU Requirements and Implementation 2016

• Why there are so many data integrity issues
• What data integrity is and why it is so important for public health
• How to define and archive raw data from hybrid systems: electronic vs. paper
• The FDA/EU/PICS/MHRA/WHO requirements for data integrity
• How to ensure and document integrity of raw data and other records according to Part 11 and Annex 11
• Specify and validate Part 11 compliant software functionality
• How to develop and implement corrective and preventive action plans in response to inspection reports
• FDA`s New and ongoing Part 11 inspection and enforcement practices
• How to prevent and detect data integrity issues
• How to avoid and/or respond to FDA inspectional observations and warning letters

Who should Attend

• Laboratory managers and supervisors
• QA managers and personnel
• Analysts
• Production managers and supervisors
• Software developers
• IT/IS managers and system administrators
• Training departments
• Regulatory affairs
• Consultants
• Documentation departments
• Quality control laboratories of API manufacturers
• Pharmaceutical development and Quality control laboratories
• Contract laboratories
• Medical device companies
• Suppliers and service providers of instruments and computer systems
• Clinical Research Organisation