Course Description A medical device production system must be efficient, effective, and compliant. This includes the right controls- documented instructions, environmental control, adequate equipment properly installed and maintained, production software, properly controlled test equipment and validated processes. The requirements come from FDA QSR, ISO 13485:2003 and ISO 13485:2016. This two-day workshop covers the essentials of production and process control. Beyond the fundamental elements, the workshop provides practical methods to help create a robust system for device production - one that can withstand a rigorous FDA Inspection. Exercises provide an opportunity to put the lessons into practice. Case studies, based on FDA Warning

Date : 31st August 2017 to 1st September 2017

Place : United States, Boston

Website :https://www.eventbrite.com/e/production-and-process-control-building-a-robust-system-ocp-tickets-33118840343?aff=NDT

Contact Person:Paula Edwards

Description:

Course Description A medical device production system must be efficient, effective, and compliant. This includes the right controls- documented instructions, environmental control, adequate equipment properly installed and maintained, production software, properly controlled test equipment and validated processes. The requirements come from FDA QSR, ISO 13485:2003 and ISO 13485:2016. This two-day workshop covers the essentials of production and process control. Beyond the fundamental elements, the workshop provides practical methods to help create a robust system for device production - one that can withstand a rigorous FDA Inspection. Exercises provide an opportunity to put the lessons into practice. Case studies, based on FDA Warning

Course Description A medical device production system must be efficient, effective, and compliant. This includes the right controls- documented instructions, environmental control, adequate equipment properly installed and maintained, production software, properly controlled test equipment and validated processes. The requirements come from FDA QSR, ISO 13485:2003 and ISO 13485:2016. This two-day workshop covers the essentials of production and process control. Beyond the fundamental elements, the workshop provides practical methods to help create a robust system for device production - one that can withstand a rigorous FDA Inspection. Exercises provide an opportunity to put the lessons into practice. Case studies, based on FDA Warning will be held in Boston,United States on date 2017-09-01

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Deadline for abstracts/proposals : 25th August 2017

Keynote Speakers : Dan is the President of Ombu Enterprises, LLC, a company offering training and execution in Operational Excellence, focused on analytic skills and a systems approach to operations management. Dan has more than 30 years experience in quality, operations, and program management in regulated industries including aviation, defense, medical devices, and clinical labs. He has a Masters Degree in Mathematics; is an ASQ certified Biomedical Auditor, Quality Auditor, Quality Engineer, Reliability Enginee

Conference Highlights :Learning Objectives Understand the regulatory environment for device manufacturers including FDA QSR, ISO 13485:2003 and ISO 13485:2016 Learn the approach regulators use to check implementation including QSIT and MDSAP Learn the requirements for installation and maintenance of production equipment Understand how to manage inspection, measuring and test equipment, IM&TE Learn the requirements for production and test software validation Understand product verification requirements and re

Venue :Boston, MA, United States

Check the event website for more details.