Presented by: Hector Felix, Senior Validation Engineer at VTI Life SciencesThis webinar will cover the best practices you must implement whether you ship or store temperature-sensitive products. Participants will learn about the regulator context, what has to be done, and how with real concrete examples and case studies.The course details will include:DefinitionTemperature Mapping IntroductionWhy should […]
Presented by:Frank Meledandri Sr., Associate Director, Quality Strategy Quality Management, BDRoy Devine, GPO Computer System Validation, BDModerator:Jason Spiegler, SVP of Strategy, Sales, and Marketing, Compliance GroupBD’s Roy Devine and Frank Meledandri Sr will share their experiences in driving a risk-based CSA methodology. In addition to touching on procedural and cultural change, they will share aspects […]
What are the main benefits of standardization of validation processes, and how do you drive standardization across an organization How do you benchmark how mature your validation processes are, and what standards to drive for. Create comprehensive training packages to align validation practices globally Focus on creating a risk-based culture How investment in technology can […]
“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 […]
