On June 17-18, 2021, ISPE will be hosting a virtual conference, the 2021 ISPE Asia Pacific Pharmaceutical Manufacturing Conference: Sustainable Implementation of Quality Risk Management. Join leaders from industry (including Lachman’s CEO and President, Fran Zipp) and representatives from international regulators to discuss many issues related to quality risk management, with special emphasis on practical application of QRM using a series of case studies, with a focus on achieving sustainability.
It has long been recognized that the biggest challenge that organizations struggle with regarding quality risk management is sustainability. The desired state is that the tools of the risk systems should be built into all quality activities, from laboratories to electronic systems, new technologies, validation processes, and even training of employees. The benefit of doing so is that QRM becomes a way of thinking, which allows individuals and organizations to be prepared for dealing with unexpected issues (such as COVID-19). As the impact of the pandemic was felt greatly in this important region, companies are being asked to adapt to new interpretations of existing regulations, contend with remote inspections from different regulators, and manage an increasing and constantly changing number of CMOs, all under shifting conditions and market demands related to dealing with a pandemic. The importance of quality risk assessment and risk mitigation have never been stronger. Register here to join the discussion.