Statistics are one of the most important tools available for the validation of processes and systems. In this webinar, we will discuss some of the most useful statistical tools that are commonly used in validation: Process Capability Analysis and Tolerance Intervals.Process Capability Analysis and Tolerance Intervals allow us to determine how well our manufacturing processes […]
This webinar will provide insight on what to consider when establishing training and qualification requirements for upper and middle management, front line supervisors, technicians and operators.Top Ten Benefits:Upper and Middle Management• Designing for Operational Readiness o People o Program Development o Training Execution• Defining Upper and Middle Management o Roles and responsibilities o Knowledge and […]
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 […]
In this webinar, you will learn the key attributes to developing effective procedures based on the foundation of Change Management, Document Management, and Risk Management (plus Design Control as appropriate for medical devices). • By planning for and creating a foundational structure, you will create a documents that ensure the information is contained in one primary […]
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 […]
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