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
Past Events
Data Integrity: FDA/EU Requirements and Implementation - 2021, (59480)
Data Integrity: FDA/EU Requirements and Implementation - 21-22 Jan 2021, Webinar (70362)
Data Integrity: FDA/EU Requirements and Implementation - 14-15 Sep 2020, Online Event (60989)
Data Integrity: FDA/EU Requirements and Implementation - 09-10 Jul 2020, Online Event (87150)
Data Integrity: FDA/EU Requirements and Implementation - 26-27 Mar 2020, University Club atop Symphony Towers, San Diego, California, United States (87149)
Important
Please, check "Data Integrity: FDA/EU Requirements and Implementation" official website for possible changes, before making any traveling arrangements
Event Categories
Health & Medicine: Medical device, Medical laboratories, Pharma
