Dr Wolfgang Schumacher, formerly F. Hoffmann-La Roche
During an inspection by the local or international Health Regulatory Bodies, all organisational and technical measures taken to ensure data integrity in the company must be demonstrated. It is necessary to show a clear structure of these activities together with the internal controls established, for example by QA. All measures should be planned on a risk-based basis, i.e. taking into account the risk for the product, the process and the patient; pragmatic approaches will help to keep the additional costs incurred under control.
The webinar will emphasize on many of the issues that could be addressed during an inspection and provide participants with appropriate solutions to ensure a successful inspection. Important topics are in particular:
- Inventory of the Systems
- Analysis of the DI Status / GAP Assessment / Data Governance
- Risk Assessment / Action Plan
- What do the Inspectors Want to See - Overview
- Audit Trail Review
- Stand-Alone Systems
- Inspection Observations
The event is aimed at managers and employees of pharmaceutical and medical technology companies and their suppliers, who are accountable to implement the current requirements for data integrity in an inspection- proof manner.
For our webinars, we use Cisco WebEx, one of the leading suppliers of online meetings. At https://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 plugin. 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.
The aim of the webinar is to provide answers and guidance to the following questions for practical application:
- What is the Best Way to Present DI Measures Taken?
- Risk-based Assessment Approach
- Involvement of the Management
- Audit Trail Review
- Inspection Observations of the FDA and European Authorities
The participants will receive an Excel sheet including the corresponding check/question list to assess the Data Integrity risk of their electronic systems