Webinar Series on Data Integrity: Preparing a data integrity inspection

Webinar Series on Data Integrity: Preparing a data integrity inspection

Course No 18189

Important: Deadline is 09.00 h CEST on 6 July 2020
 
You will find all webinars of this series in in this overview.

Costs

ARE YOU INTERESTED IN THIS SEMINAR?

Please contact us and we will inform you accordingly:

If you have any questions, please contact us:
Tel.: +49 (0)6221 / 84 44 0 E-Mail: info@gmp-compliance.org

Speakers

Dr Wolfgang Schumacher, formerly F. Hoffmann-La Roche

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:
  • ƒWhat 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

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