Lean Medical Device Manufacturing

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Take your skills to the next level and earn your certificate.

Classes can be taught at your company!

• Intro to FDA, cGMP and Lean
  The FDA has specific regulations that pharmaceutical and medical device manufacturers must follow. This class will provide an introduction to FDS cGMP requirements and how they impact Lean. Students will also learn how to satisfy FDA requirements and continue to make dramatic improvements with Lean. Topics will include validations, clean rooms, lot traceability, and more.
  
• Lean Six Sigma 101 for the Pharmaceutical and Medical Device Industry
  Lean and Six Sigma are powerful improvement methodologies that are being applied in every industry. Applying Lean and Six Sigma within Pharmaceutical and Medical Device manufacturing requires a modified approach due to FDA regulations. This class will introfuce the concepts of Lean and Six Sigma relative to Manufacturing Pharmaceuticals and Medical Devices.
  
• Design, Process, and Use FMEA's for the Pharmaceutical & Medical Device Industries
  Designing and manufacturing pharmaceuticals and medical devices involves risk and requires satisfying additional regulations. Failure Modes and Effects Analysis (FMEA) is an important tool for minimizing risk. This class teaches when to use FMEA's and how to use them to minimize risk and products are designed, processes are designed and how the pharmaceutical or device is intended to be used in the healthcare setting.
  
• Product and Process Design in Pharmaceutical & Medical Device Manufacturing
  Design new products and new process is critical to the long-term growth and success of pharmaceutical and medical device manufacturers. This class teaches methodologies on how to design new products and new processes utilizing the tools of Lean in regulated environments.
  
• Setup Reduction
  Setup Reduction is a toolset within Lean that can be highly leveraged in all pharmaceutical and medical device manufacturing companies. Effectively utilizing the tools of setup reduction within a regulated environment requires specialized application of these tools. This class will take you through the special requirements you need to consider.