Why do people fear statistics? Could it be:
These are good reasons to be fearful. Key2Compliance is providing an avenue to cut through the jungle and find safe pathways to understanding and immediate application. This 3-day, hands-on workshop will be provided on-line. The statistical material is covered in a practical manner. It is not over-burdened with statistical complexity. Industry-specific examples are provided throughout the workshop. Participants will apply user-friendly statistical software and data files to work problems with small groups. Our goal is to foster correct, immediate, and sustained application. The material provides product and process experts in US FDA-regulated firms a solid understanding of how to use valid statistical techniques for their needs. It focuses on specific methods and tools that assist with the challenges of Process Analytical Technology (PAT), Design Control, Process Validation, Corrective & Preventive Action (CAPA), complaint monitoring, and other mandated activities. The content is based on the requirements of the US FDA’s Quality System Regulation and the recommendations of the Global Harmonization Task Force (GHTF).
The content should have great value to industry professionals involved with: research and development, new product development, process development, manufacturing engineering, operations, quality engineering, quality assurance, supplier quality, and regulatory compliance.
Participants do not need a background in statistics. A basic familiarity with Microsoft Excel would be helpful, but not required. Participants are will receive Microsoft Excel-based software and Excel data files. The software requires a Windows operating system and Excel software. The software and data files must be loaded prior to the workshop.
A WINDOWS-BASED LAPTOP WITH MICROSOFT EXCEL IS REQUIRED. A statistical software package will be provided. It is a Microsoft Excel application (SPC XL)
This software is only compatible with Windows operating systems. System requirements: http://www.sigmazone.com/spcxl_sysreqs.htm
This course is available as an In-House Training course. Let us know if you wish to customize a course or if you are a large group with the same requirements.
Leading specialist with long experience of training are guiding you through regulations, guidelines, interpretations, requirements and applications.
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