Webinar Series on Data Integrity: Preparing a data integrity inspection
Monday, 6 July 2020 14.00 - 16.00 h
Course No. 18189
Speakers
Dr. Wolfgang Schumacher
ehem. F. Hoffmann-La Roche
Important: Deadline is 09.00 h CEST on 6 July 2020 You will find all webinars of this series in in this overview.
Background
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
CAPAs
Inspection Observations
Target Group
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.
Technical Requirements
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.
Programme
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
Course Material The participants will receive an Excel sheet including the corresponding check/question list to assess the Data Integrity risk of their electronic systems
Testimonials