Christof Langer, OSConsulting
Already in 2008, the International Council for Harmonisation (ICH) published the guideline ICH Q10 Pharmaceutical Quality Systems. This was adopted within the EU in Part 3 of the GMP Guidelines.
The document has created a regulatory basis for new, modern quality assurance systems (to be mentioned here are, among others, knowledge management, quality risk management, elements of continuous improvement, etc.) and emphasises the importance and management responsibility. The elements have been adopted in other chapters of the EU-GMP Guidelines and should be applied appropriately for each of the product lifecycle stages. Unfortunately, not all pharmaceutical companies have yet managed to integrate the systems effectively and successfully.
This webinar is designed for those who deal with the topic of pharmaceutical quality systems and are looking for solutions and/or optimisation possibilities.
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.
This webinar is designed to explain the regulatory requirements and their practical implementation in the pharmaceutical industry. This is conveyed through various examples.
Recording from 08.07.2020
Duration of the recording: about 1.5 h