Dr Wolfgang Schumacher, formerly F. Hoffmann-La Roche, Switzerland
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.
To participate in an on demand training course or webinar, you do not need any software. The recordings are made available via a streaming server. In general, the recording is provided in MP4 format, which any PC (Microsoft Windows, Apple IOS) or tablet can easily display.
Timing and Duration:
When you register for the on demand Training course or webinar you can decide at what date you want to follow the training course online. For a 1-day training course you will have 2 days in which the stream is available (for 2-day training course 3 days and for a 3-day training course 4 days). Within in this timeframe you can start & stop the stream according to your needs.
In time before the scheduled date (your desired date) you will receive an e-mail from us with a link for direct participation as well as your log-in data.
Training Course Documentation and Certificate:
The presentations will be made available as PDF files via download shortly before the online training course. After the event, you will automatically receive your certificate of participation.
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
Recording from 06.07.2020
Duration of recording: about 1,5 h.