ISO 13485 – IQOQPQ – Process Validation for Medical Devices
Udemy free download ISO 13485 - IQOQPQ - Process Validation for Medical Devices, with this course you can Installation Qualification (IQ), Operational Qualification (OQ) & Performance Qualification (PQ) || Medical Devices This course By Phaniendra Somraj "ISO 13483 Lead Auditor| Master Black Belt in LSS".
9 lectures and 2 generic quizzes On-demand course with full lifetime Access multiple devices. DOWNLOAD YOURS NOW.
One way to know the usability of the course to know how many students took the course. Because if large number of people are taking this course, it means it has some value. So far, the total number of enrolments have crossed 1051.
But enrolment alone is not a good yardstick to measure the value of any course. But positive reviews are!
This Udemy free download course was created in created and has an average 4 star rating out of 5. The total reviews for this course are 325 which is a number of reviews and ratings.
What Will You Learn From This Course?
- 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
- Medical Device Development NPI
- Teach IQ OQ PQ to your teams and collaborate better
- Molding Qualification
- Injection Molding Process Validation
What this instructor say's about His tutorial ?
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 understand a QE and QC lab perspective, the Instructor covered all those important bases to make this course holistic to manage and be successful.
This course will teach you cross collaboration activities involved in Process Validations from Engineering responsibility to Quality to Operations.
This is a high collaboration work with various hand offs between various functions in your organization, but once trained on the overall process, you will be ready to start. The first 2 product launches will help you identify the processes and the bottlenecks within, and when you are ready to launch your third product, your team's maturity on the process will help a lot to successfully & smoothly do your Process Validation.
The standards and FDA requirements have a lot of room for interpretation, the Instructor has taken his best diligence to provide guidance through this course. At the end of this course, you will have been provided with an overview of the Process Validation regulatory requirements and what you need to perform them without any bottlenecks in your organization.
A very good luck on this journey.
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Udemy Free Download ISO 13485 - IQOQPQ - Process Validation for Medical Devices