Medtec2013 v1jn
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This document discusses balancing regulations with engineering innovation when designing medical products. It addresses key aspects of regulation including timelines, elements, enforcement, and common pitfalls. Engineering fields like mechanical, manufacturing, and software engineering are discussed. The presentation emphasizes finding a balance between meeting regulations and advancing engineering through commitment and considering equipment, processes, quality, and documentation. An example of a CNC machine with integrated quality control is provided. References for further information on FDA regulations and guidance documents are also included to spark discussion.
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Medtec2013 v1jn
- 1. Balancing and conforming with existing standards whilst designing innovative products BALANCE Regulation and Engineering Jasmin NUHIC Senior Manager, Manufacturing Engineering Medtronic, Inc February, 2013
- 2. Changing Minds MEDTEC 側 Stuttgart, 2013 2
- 3. Topics Regulation Engineering Balance Example References Discussion MEDTEC 側 Stuttgart, 2013 3
- 4. Regulation Timeline Elements General Scope Electronic records Electronic signatures Audit trails Enforcement MEDTEC 側 Stuttgart, 2013 4
- 5. Regulation (cont`d) Target areas Common audit findings Common pitfalls "All Part 11 systems must be validated; Benefits of being yet not all validated systems must be Part 11 compliant" compliant Training MS Word 束Track Changes損 is 21 CFR Part 11 compliant? MEDTEC 側 Stuttgart, 2013 5
- 6. Engineering Mechanical (equipment) eng. Manufacturing eng. Industrial eng. Software eng. Process eng. Quality eng. R&D eng. ...... eng. MEDTEC 側 Stuttgart, 2013 6
- 7. Balance SUCCESS Euipment Process (control) Quality (control) Y Documentation O U Supply chain REGULATIONS ENGINEERING Customer feedback Supporting activities COMMITMENT MEDTEC 側 Stuttgart, 2013 7
- 8. Example DANTRON CNC machine with CMM built in Equipment, Process, Quality all in one Automated and combined to save time, space and energy Engineering balancing SAMPLE IMAGE, courtesy of Dantron Technology http://www.datron.de/uk/products/machine- tools/milling-machines/m8cube-milling-machine.html regulation MEDTEC 側 Stuttgart, 2013 8
- 9. References FDA Website www.fda.gov/ora/compliance_ref/part11 International Society for Pharmaceutical Engineering (ISPE) GAMP5, A Risk-Based Approach to Compliant GxP Computerized Systems John Murray Software and Compliance Specialist with FDA (Part 11 Subject Matter Expert and advisor) MEDTEC 側 Stuttgart, 2013 9
- 10. Discussion THANK YOU! MEDTEC 側 Stuttgart, 2013 10