Furthermore, production of biologics includes feedstock variability and complex multi-step manufacturing processes in batch operation with variable lots – condition, which apply to botanicals as well. The use of rigorous (physico-chemical) process modeling in combination with QbD results in a high ...
• Applied Failure Mode Effects Analysis (FMEA) to toolsets to target and resolve potentially critical issues. • Developed process recipe, designed DOE to test the reliability of process. • Coordinated successful process transfer from a development facility to a high volume manufacturing facility...
Design for manufacturingand assembly (DFMA) : combination of two methodologies: Design for Manufacture (DFM), which is the process of optimizing the design to be easier to produce, have higher throughput, and improved quality; and Design for Assembly (DFA), which is the optimization of the des...
Testing, Validation, Setting Requirements, Failure Mode & Effect Analysis (FMEA), and Design Reviews by themselves do not improve a product; they only provide information that has to be translated into Design/Manufacturing & Service tasks. The quality of these tasks determines how well the new ...
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Quality Management and Control for the Whole-Process Logistics Service of Multi-Variety Small-Batch Production and Manufacturing Guided by market orientation, the traditional mass production mode has gradually shifted to the multi-variety small-batch production mode, so it's of certa... Ding Wang -...
• Process Characterization, Qualification and Validation (IQ, OQ, PQ). • Perform complaint investigation on returned products in accordance with ISO 13485. 2008 - 2013 Packaging Engineer Merck & Co. · Main, PA • Participated in risk assessment (FMEA) of leachable and extractable. • ...
Micro-assembly robots are usually equipped with micro-vision for monitoring the assembly process [4–6]. However, micro-vision is problematic in that the larger the magnification, the smaller the field of view (FOV), that is, there is a contradiction between high precision detection and wide ...