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 […]

Participants will benefit from understanding the current international regulations for 1-Stage Process Validation as well as realizing the significant business benefits that come from taking a science and risk-based approach.Current Regulatory Expectations (FDA Stage 1)· Clarify similarities and differences between EU and US expectations· Establish a three-stage, science and risk-based, lifecycle process validation programmed.· impact […]