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 […]
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 […]
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 […]
There are two parts to this webinar: 1) CSA and data integrity GPG DI alignment; and, (2) Insert more data integrity so we don’t bore people with CSAHear directly from the source, FDA – Industry CSA Team & Colleagues in a Panel setting discussing the upcoming ISPE GAMP Good Practice Guide (GPG) Data Integrity (DI) […]
