This live online training course is offered by a collaboration of Minnesota State colleges.
Gain a basic knowledge of Medical Device Manufacturing and many of the processes and activities associated with it. This course is intended for individuals who currently work in a factory environment (or would like to make a career change) and desire to learn the basics of Medical Device Manufacturing. It is also an ideal training for medical manufacturing companies to help “kick-start” employees such as new hires, persons who currently do warehouse or shipping work, and other important functions but do not yet have experience in direct hands-on manufacturing operations.
No prior experience in medical device manufacturing is required to successfully complete this course. Several hours of self-study work will be required (outside of the six class sessions) to complete the course as it is intended.
- Overview of the FDA and its role in regulating the industry
- Types, categories, and examples of medical devices
- The FDA Quality Systems Requirements: 21 CFR 820.xx for med device manufacturing
- ISO 13485 (ISO device mfg.) vs. 21 CFR 820.xx (FDA) vs. ISO 14971 (ISO risk assessment)
- Measuring, inspection, and test equipment: selection, methods, calibration, validation
- Process and Equipment Validation requirements: IQ-OQ-PQ protocols and reports
- Overview of basic statistics: Statistical process control, spec. limits vs. process control limits
- Class exercise: example performance IQ-OQ-PQ on hypothetical heat-seal packaging machine
- Device packaging, labeling, and sterilization
- Clean rooms: what they are, requirements for gowning and compliance
- Document controls, Standard Operating Procedures (SOP’s), Inspection Procedures (IP’s), Manufacturing Procedures (MP’s), Learning Management Systems (LMS)
- FDA requirements for validated Electronic Records, Signature Verification
- Non-Conforming Product: FDA required controls
- CAPA Corrective & Preventive Actions
- Conditions and reasons why revalidation (processes etc.) may be necessary
About the Instructor:
Robert J. Bach is a licensed professional mechanical engineer in the state of Minnesota, a master journeyman toolmaker, and earned a Master of Science degree in Manufacturing Systems at St. Thomas. Bob currently serves as a clinical professor and program director for the School of Engineering at the University of St. Thomas and has been engaged in precision manufacturing for over 30 years.
At MN State, he teaches geometric dimensioning & tolerancing, CNC Machining Basics, and Medical Device Manufacturing & Process Validation courses via “Live Online” and has developed & instructed many customized training courses at Minnesota companies.
Prior to teaching full time, Bob was a senior manufacturing engineer for 10 years at St. Jude Medical, working on design-to-production transfer for heart valves and other cardiovascular devices. His expertise includes machine design, equipment validation, and process improvement using design of experiments (DOE) and statistical analysis. Before St. Jude, Bob worked many years as a tool process engineer and a tool & diemaker at Honeywell.