APAC PHARMACEUTICAL MANUFACTURING CONFERENCE Opening Plenary Session | Quality Risk Management: Beyond Theory to Practical Implementation
Many international regulatory authorities have published guidance/draft guidance on Quality Risk Management, as well as ICH and WHO. This fact highlights the importance of QRM in manufacturing and quality operations: it helps coordinate and direct an organization's activities to meet customer and regulatory requirements; it helps in day-to-day decision making within the quality and manufacturing units; it helps ensure the effectiveness of CAPAs; and it helps organizations improve effectiveness and efficiency on a continuous basis. However, despite the clear benefits and need for QRM, organizations often struggle with implementing one fully. In this session, we will discuss the practical implementation of a QRM and how to integrate and avail the organization to the resulting benefits in daily operations and sustainable supply.