Dr Franz Schönfeld, District Government of Upper Franconia
Data Integrity is still a major concern with both the FDA and European Regulatory Agencies. Many FDA warning letters and EU GMP inspections have highlighted major data integrity failures at companies worldwide. Data integrity is not a new topic: The principles apply to electronic and to paper-based systems. Major topics cover
- IT Security, System and Data Integrity
- Written Policies
- Data Life Cyles
- Principles of ALCOA+
- Handling of Raw Data Review of Data
As electronic date is widespread in Quality Control but also in Production it is getting more and more interest of GMDP inspectors.
This webinar is addressed to employees of pharmaceutical manufacturers, authorities and suppliers with responsibility in
- Quality assurance
- Quality Control
- Inspections and Audits
For our webinars, we use Cisco WebEx, one of the leading suppliers of online meetings.
At http://www.webex.com/test-meeting.html you can check if your system meets the necessary requirements for the participation at a WebEx meeting and at the same time install the necessary plug-in. Please just enter your name and email address for the test. If the installation is not possible because of your rights for the computer system, please contact your IT department. WebEx is a standard nowadays and the necessary installation is fast and easy.
Major objectives of this webinar are as follows:
- Basic Regulatory Requirements
- IT Security and User Management
- Handling of Data (including Raw Data)
- Data Integrity
- Examples (Production and Quality Control)
- Inspection Findings