Statistical Methods & Tools for Medical Device and Pharmaceutical Firms

This 3-day, computer-based workshop provides product and process experts in FDA-regulated firms a solid understanding of how to use statistical tools and methods for their needs. It focuses on specific methods and tools that assist with the challenges of Design Control, Process Analytical Technology (PAT), Process Validation, and other mandated activities. The content is based on the requirements of the 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 our ever-popular software tool, SPC-XL, are given to foster correct, immediate, and sustained application. 

Fundamental Concepts for Quality Systems
Measurement System Analysis (aka, Gage R&R)
Drawing Conclusions Using Data
Creating Sampling Plans
Performing Capability Studies
Applying Control Charts

Design of Experiments for Medical Device and Pharmaceutical Firms

This 3-day, computer-based workshop provides product and process experts in FDA-regulated firms a solid understanding of how to use Design of Experiments (DOE) for their needs. It focuses on applying DOE to meet the requirements of Design Control, Process Analytical Technology (PAT), Process Validation, and other mandated activities. Industry-specific examples are provided throughout the workshop to illustrate how to obtain the maximum amount of information with the minimum amount of resources. The material is covered in a practical manner and there is no prerequisite knowledge to attend. It is not over-burdened with statistical complexity. Guidelines, rules of thumb, and our ever-popular software tool, DOE Pro XL, are given to foster correct, immediate, and sustained application.
Fundamentals of Design and Analysis
Screening Designs and Analysis
Modeling with Two- and Three- Level Designs
Response Surface Studies and Optimization
Robust Design Methods
Introduction to Design for Six Sigma (DFSS)

Risk Analysis and Management

This is a very popular 2.5-day, case-based workshop that provides product and process experts a working knowledge of Risk Analysis. Furthermore, the participants understand how to apply the results to help manage projects. The content is flexible — classroom exercises are selected based on applications relevant to the audience. Participants learn how to lead and facilitate risk assessments, thus fostering correct, immediate, and sustained application. A special version of this workshop has been provided to many FDA-regulated medical device and pharmaceutical manufacturers. 

Foundations of Risk Management
Initial Hazard Analysis & Evaluation
Design Failure Mode & Effects Analysis (D-FMEA)
Process Failure Mode & Effects Analysis (P-FMEA)
Fault Tree Analysis (FTA)
Putting It All Together
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