All valid reasons to be fearful. Fortunately, we are providing an avenue to overcome this fear and find safe pathways to understanding and immediate application. We will give many examples of application by medical device and pharmaceutical manufacturers. And, better yet, these examples motivate methods that save time, money and resources.

Product and process experts in regulated firms will gain 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: Design Control, Process Validation, CAPA, complaint monitoring and management review. The content is based on the requirements of the US FDA’s Quality System Regulation, ISO 13485, and various industry standards.

These two fast-paced workshops will cover the details of application without the burden of statistical complexity. The presenter’s “keep-it-simple” approach will avoid statistical complexity – participants do not need to have a background in statistics.

You will hear directly from an industry expert on this important topic, and you can ask questions and get answers. The presenter has over 30 years of experience helping a broad variety of firms apply statistical tools and techniques.

PROGRAM OVERVIEW:

• Explore valid statistical techniques that foster product and process quality
• Provide a mapping of tools and techniques for regulated activities
• Provide examples of industry’s best practices in each area
• Demonstrate how these tools support regulatory compliance, especially if mandatory or voluntary action is required

PROGRAM-AT-A-GLANCE - PART ONE

• Setting the Stage for FDA-requirements and expectations
• Test Method Validation
• Exploring Historical Data
• Process Capability Measures
• Question and Answer Period

PROGRAM-AT-A-GLANCE - PART TWO

• Applying Design of Experiments
• Sampling Plans
• Statistical Process Control (SPC) Charts 
• Question and Answer Period

This material will appeal to quality professionals and managers in industry and regulatory agencies. Instruction is targeted to quality engineers, design engineers, process & manufacturing engineers, regulatory compliance professionals, and members of the leadership team.