Valid Statistical Techniques Made Easy

Course description

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?

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).

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

Case studies

• I keep hearing that we only need three production runs for Performance Qualification (PQ). Our lead Quality Engineer keeps telling me that this is wrong. Who is right?
• A competitor just received a Warning Letter from the FDA for misapplying standards for sampling procedures for inspection by attribute. We are in an acronym jungle: AQL, AOQL, LTPD, LQ, CRQ, Ac, Re, α, β, … What is important for us to do?
• For a new device we will only manufacture one device every month. How can we satisfy the FDA’s requirements for Performance Qualification (PQ)?
• The customer of our components is finding more defective items than our inspection system finds. Is there a simple way to find agreement between our inspection system and theirs?
• We perform safety-critical attribute inspections of our device but are only 90% effective. How can we improve our effectiveness?
• The FDA Quality System Regulation says that we should apply appropriate statistical techniques to detect recurring quality problems. Is there an easy way to meet this requirement? What if our quality problems are rather rare?
• How do I qualify my inspection, measuring and test equipment to satisfy FDA requirements? Do I have to do this for automated test systems?

Learning objectives

• Know how to interpret and implement the requirements of 14971:2019 in your quality management system
• Define key input and output of the risk management process
• Understand the lifecycle approach to risk management
• Identify the links between ISO 13485:2016, ISO 14971:2019 and the medical device regulations

Who should attend

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.

Prerequisites

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.

Equipment and software needed

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