Presented by: Rui Almeida, Director, Product Life Cycle Management Services, ValGenesis. Inc. Cleaning validation is a complex process. Over the years, the industry has moved on with a structured risk based lifecycle approach following FDA Process Validation Lifecycle principal guidance. Using old processes, it remains a challenge to eliminate human errors. This presentation shows how […]
Presented By: Geetanjali Abbi, Director, Digital Quality Assurance, Alkermes This case study is intended to walk the audience through the transformative journey that Alkermes has been through since our initial transition to ValGenesis 7+ years ago. This will include a discussion on how ValGenesis helped us sustain the workload during the pandemic, lessons learned (both […]
Presented By: Steve Thompson, Senior Director Product Marketing, ValGenesis • Recent technology advancements that are promising and problematic? • Learning from our past mistakes – How catastrophes became the catalyst for regulatory action • Assessing our current risk management process(es) • Establishing governance for advanced technologies • Knowing who’s ultimately responsible, and how to protect […]
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