Iso 13485 - Iqoqpq - Process Validation For Medical Devices
Last updated 9/2022
MP4 | Video: h264, 1280x720 | Audio: AAC, 44.1 KHz
Language: English | Size: 283.12 MB | Duration: 0h 57m
Installation Qualification (IQ), Operational Qualification (OQ) & Performance Qualification (PQ) || Medical Devices
What you'll learn
Process Validation of Medical Devices using IQOQPQ Phases to meet ISO 13485 standard requirements and FDA regulations.
In less than 2 hours you can be an Expert on how to perform Process Validation in your Manufacturing facility
Create a Process Validation Procedure
Perform Installation Qualifications
Perform Operational Qualifications
Perform Performance Qualifications and launch your New product Introductions regime
Plan your New Product Introductions (NPIs)
Teach IQ OQ PQ to your teams and collaborate better
Molding Qualification
Injection Molding Process Validation
Requirements
Basic knowledge of Quality inspection will help
Description
Based on some of the feedback I got on this course, I am continuously improving the presentations to make the learning experience more value add for you. Thank you and I greatly appreciate your support on this journey!!-------Process Validation of Class 1/2/3 Medical Devices shall meet ISO 13485 standard and FDA 21CFR 820.75 requirements. The objective of the course is to provide the course audience with the tools and knowledge to use the Process development, Quality principles and Program management to perform their Process Validation activities to meet regulatory, compliance and customer requirements.It is a vast subject completely based on YOUR products, medical device class, team size, manufacturing method etc.The course is explained with various phases and links to make a New Product Launch Validation successful. A Designer doesn't get a manufacturing perspective, a Process Engineer doesn't...
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