Production and Process Control_ Building a Robust System (NTZ)

Production and Process Control: Building a Robust System (NTZ)
At
Hilton Garden Inn O'Hare

For more information: https://www.eventbrite.com/e/production-and-process-control-building-a-robust-system-ntz-tickets-43481361924?aff=RMV


DESCRIPTION
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Production and Process Control: Building a Robust System

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 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 or MDSAP Audit.



Why you should attend:
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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 implement them.


Workshop Objectives
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Understand the regulatory environment for device manufacturers including FDA QSR 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
etc..

Who will benefit:
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Production Managers and Supervisors
Quality Managers and Supervisors
Quality Engineers
Manufacturing Engineering Managers and Supervisors
Manufacturing Engineers
Quality Management System Auditors
Risk Management Specialists
Regulatory Affairs and Compliance Staff

Please contact the event manager Marilyn below for the following:
- Discounts for registering 5 or more participants.
- If your company requires a price quotation.
Event Manager Contact: marilyn.b.turner(at)nyeventslist.com
You can also contact us if you require a visa invitation letter, after ticket purchase.
We can also provide a certificate of completion for this event if required.
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For more information: https://www.eventbrite.com/e/production-and-process-control-building-a-robust-system-ntz-tickets-43481361924?aff=RMV


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