Webinar - ICH Q10

Webinar - ICH Q10

Course No 18198

Important: Deadline is 12.00 h CEST on 7 July 2020

Costs

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Speakers

Christof Langer, OSConsulting

Background

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.

Target Group

This webinar is designed for those who deal with the topic of pharmaceutical quality systems and are looking for solutions and/or optimisation possibilities.

Technical Requirements

For our webinars, we use Cisco WebEx, one of the leading suppliers of online meetings. At http://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 plug-in. 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

This webinar is designed to explain the regulatory requirements and their practical implementation in the pharmaceutical industry. This is conveyed through various examples.

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