Since the publication of ICH Q9[1] in 2005, the pharmaceutical industry is encouraged to take a risk-based approach to the control and management of product quality. The expectation that Quality Risk Management (QRM) is integrated into the Pharmaceutical Quality System (PQS) is further developed in ICH Q10 [2]. ICH Q10 objectives are to achieve product […]
The earliest documented interest in Operational Excellence (OPEX) in the pharmaceutical industry occurred in the late 1990s – twenty years after other manufacturing sectors began to think of OPEX as a competitive imperative. Since then, little progress has been made based on our experience working with clients. In some cases, tremendous short-term improvements are made […]
Your ability to hire, train, inspire, and retain proficient staff in all departments will either propel your site to success or leave you stranded short of your operational goals.In our journey through the steps to bridge the chasm from Project mode to Operational Readiness, we arrive at the point where we must prepare to staff […]
In Part 1 of our series, we defined Operational Readiness for our industry and described the high-level approach to best achieve it. In this session we will walk through the stages of actions needed to identify and control the operational issues that often occur post-startup. The bulk of these actions are best performed within logical […]
This webinar introduces participants to a different way of thinking about Speed to Market that calibrates our understanding of what it means to be Operationally Ready. Speed to Market has its apparent advantages, yet few organizations establish suitable systems to achieve one of the key milestones to make Speed to Market a reality — achieving […]
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