Webinar on Improving Process Stability and Capability – Tips, Traps and Guidance
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Category ASQ, Clinical & Laboratory, FDA Compliance, Food, Drugs & Biologics, Medical Devices, Statistical
Deadline: February 09, 2017 | Date: February 09, 2017
Venue/Country: Online, Canada
Updated: 2016-12-19 22:51:06 (GMT+9)
Call For Papers - CFP
FDA’s Process Validation Guidance Stage 3 calls for “ongoing assurance is gained through routine production that the process remains in a state of control.” Two critical considerations in assessing process behavior are process stability and capability. Tools commonly used to demonstrate that a process is in a state of control include: control charts, process capability indices, analysis of variance and graphics. Unexpected problems are often encountered when using these tools. In this session “tips and traps” are discussed that enable pharmaceutical scientists and engineers to develop effective process monitoring systems and avoid commonly encountered problems and pitfalls.The issues discussed include: how to reduce false out of control signals, measures of process stability, how to identify causes of out of control signals, how to select the appropriate sampling procedures. The approaches and tools discussed are illustrated with pharmaceutical and biotech case studies and examples.Areas Covered in the Session :Reducing False Out of Control SignalsHow to Use Process Stability MetricsSelecting Appropriate Sampling ProceduresIdentifying Causes of Out-of-Control Signals – The Usual SuspectsEarly Warning Devices for Detecting Process ShiftsHow to Select the Right Control ChartCan We Reduce SamplingAssessing the Pedigree of Your DataTips, Traps and Guidance – What to Watch Out ForWho Will Benefit:Production ManagersProcess and Manufacturing EngineersQuality Assurance Managers, Scientists and EngineersQuality EngineersLab Testing PersonnelResearch and Development ScientistsProduct Development PersonnelBiologists and MicrobiologistsChemists and Chemical EngineersSupply Chain ProfessionalsProcess Improvement Professionals
Keywords: Accepted papers list. Acceptance Rate. EI Compendex. Engineering Index. ISTP index. ISI index. Impact Factor.
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