“Computer System Validation” (CSV) has remained mostly unchanged for the past two decades. General Principles of Software Validation (GPSV), issued by the FDA in 2002, has been and continues to be the primary tool industry uses as guidance on this topic. CSV, as it stands today, is a documentation heavy exercise Documentation is done at […]
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 […]
Join us as we discuss four different ways of using the process risk control strategy to determine EM sampling.Part 1 – Holistic Process Risk Control Strategy• Process Risk Assessment and establishing a holistic riskcontrol strategy• Environmental risks and risk controlsPart 2 – Environmental CQAs and CPPs• Environmental CPPs and the product CQAs impacted• ISO classifications […]
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 […]
Join us as we discuss the setup for success – Defining Workstreams, Process Flows, and People.Building Workstreams – Generation of a high level view of the project• Defining workstreamso Categories of work – Centers of Excellence (COE)o Individuals or departments critical to the project successo Consisting of subject matter experts from specific areas• Creating workstreamso […]
