Computerised System Validation: GMP Compliant Documentation - Online Training Recording
Course No. 22079
Speakers
Dr Rainer Gnibl
GMP Inspector
Yves Samson
Kereon
Dr Bernhard Appel
Roche
Objectives
GMP-relevant computerised systems must be validated. The validation activities shall be sufficiently documented in order to allow inspectors as well as internal and external auditors to review and to understand the validation rigour and accuracy. The online training will give an overview of the necessary qualification and validation documentation, including its structure and level of detail. The responsibilities of both suppliers as well as their regulated customers will be considered.
Background
“What is not documented has not been done!” The accurate documentation of all CSV activities is the prerequisite for successfully passing regulatory inspections as well as customer audits. On the other hand, creating the documents and maintaining their integrity is also time-consuming and costly. Here it is important to find a balance between “as few as possible but as much as necessary”.
Target Group
This Online Training is directed at employees from the pharmaceutical industry and suppliers who have to prepare CSV documents and to document the validation activities of the computerised systems or who will have to carry this out in the future. Both beginners and employees with initial experience are addressed.
Technical Details
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.
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