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