and Process Control: Building a Robust System” conference has
been added to ResearchAndMarkets.com’s offering.
Course “Production and Process Control: Building a Robust System” has
been pre-approved by RAPS as eligible for up to 12 credits towards a
participant’s RAC recertification upon full completion.
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 and ISO
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 or MDSAP Audit.
Exercises provide an opportunity to put the lessons into practice. Case
studies, based on FDA Warning Letters, the Quality System Inspection
Technique (QSIT), and the Medical Device Single Audit Program (MDSAP)
provide an opportunity to apply the information.
Why you should attend:
Production and process control is the essence of medical device
manufacturing. It provides the framework for making devices, verifying
them, validating processes, and handling problems. A device
manufacturer’s production needs to satisfy the regulatory requirements
to avoid MDSAP audit findings and FDA Warning Letters. By attending this
workshop, you will learn the regulatory requirements and tools to help
For more information about this conference visit https://www.researchandmarkets.com/research/tkb88g/two_day?w=4
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