Dr Wolfgang Schumacher, formerly F. Hoffmann-La Roche, Switzerland
In the past, in particular larger companies were requested by the authorities to take appropriate measures for ensuring Data Integrity. However, inspectors are now also asking small and medium-sized pharmaceutical facilities to present all DI elements during an inspection, mainly in QC and production. In this context it will be not sufficient to show only high-level documents (DI policy, DI SOP); rather, they are demanding to disclose a well-defined strategy, in which all measures including CAPAs together with a timetable are included.
The webinar will present pragmatic approaches to how data integrity can be defined, maintained and presented in a smaller company without excessive additional financial outlay. The speaker will also highlight some of the topics and issues that may be addressed during an inspection, in particular:
- Structure of the data integrity program
- Which documents are primarily required?
- Prioritization of activities
- Required capacity, timetable
- Data Governance
- Responsibility of the management
- Actions in case of data integrity Problems
The event is aimed at managers and employees of pharmaceutical and medical technology companies who have to implement the current requirements for data integrity in their premises 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 to the following questions for practical application:
- Which is the optimal form to present DI remediation measures?
- Documentation of the strategy
- Involvement of the management
- Activities in laboratory and production facilities
- Audit Trail Review - is that really necess
Participants receive an example of a DI Policy and the corresponding DI SOP.
Recording from 21.07.2020
Duration of recording: about 1,5 h.