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Kursusbeskrivelse
Valid Statistical Techniques Made Easy
Why do people fear statistics? Could it be:
- The subject is too complex and difficult to understand?
- They get overwhelmed by the terminology in regulations, standards, and guidance documents?
- Statistical software tools are a maze of terms and menu paths?
Good reasons to be fearful. Key2Compliance is providing an avenue to cut through the jungle and find safe pathways to understanding and immediate application.
Course outcome
The primary goal is for all participants to be able to immediately apply valid statistical techniques. Students are provided a Participant’s Guide and very user-friend software. The Guide is filled with examples of application. The participants will receive data files so they can work in teams to solve practical problems. Thus, the workshop stresses practical application instead of theory. A background in statistics in not required.
Course description:
This 3-day, computer-based workshop 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, CAPA, 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).
Industry-specific examples are provided throughout the workshop. The statistical material is covered in a practical manner. It is not over-burdened with statistical complexity. Guidelines, rules of thumb, and a very user-friendly software tool are given to foster correct, immediate, and sustained application.
Course Outline:
- Fundamental Concepts for Quality Systems
- Performing Process Capability Studies
- Conducting Test Method Validation (aka, MSA and Gage R&R)
- Sampling and Drawing Conclusions
- Creating Acceptance Sampling Plans
- Applying Control Charts
When attending a Key2Compliance® course, you get access to Gate2GMP®, our document library and search tool.
Målgruppe
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. Although not required, a basic familiarity with statistical concepts would be helpful. A basic familiarity with MS Excel would also be helpful for the in-class exercises.
Pris
The price of this course is 20.450 dkk excl. VAT.
Early bird price: 18.250 dkk excl. VAT.
Om udbyderen
Key2Compliance® er et uafhængigt internationalt netværk, der tilbyder kurser og produkter til forskellige funktioner i Life Science-branchen, fra udvikling til marked med hensyn til kvalitetssystemer og GMP-overholdelse. Ved at hjælpe organisationer med at imødekomme GMP / QS-forventninger, forbedre arbejdsstyrkens viden...
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