Successful product validation depends on operational readiness: facility and equipment, development knowledge with thorough analytical and process design documentation, trained cross functional staff at the manufacturing site and a robust formulation and process. Prior to the validation phase, successful technical transfer must be completed with robust information transfer from development to manufacturing. The validation process […]
This paper addresses how to qualify a Biological Safety Cabinet(BSC) and includes a description for Installation and Operational Tests that should be included as part of the Qualification process.Despite having robust design and environmental monitoring, cleanrooms are at risk for several sources of contamination. In this case, BSCs, if purchased with much consideration, are the […]
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 2-Stage Process Validation as well as realizing the significant business benefits that come from taking a science and risk-based approach.Facility Design and Qualification of Equipment and Utilities (FDA Stage 2.1)· Utilizing technology transfer data from stage 1 to support development of CQAs and CPPs.· Facility […]
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 […]
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