Udemy course ISO 13485 – IQOQPQ – Process Validation for Medical Devices by Phaniendra Somraj
ISO 13485 – IQOQPQ – Process Validation for Medical Devices is the best Udemy course on the market. With this offer they will be able to greatly improve their knowledge and become more competitive within the Business category. Therefore, if you are looking to improve your Business skills we recommend that you download ISO 13485 – IQOQPQ – Process Validation for Medical Devices udemy course.
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Course data:
- Author: Phaniendra Somraj
- Course rating: 4.3
- Category: Business
- Modality: Online
- Status: Available
- Idiom: English
Abouth Phaniendra Somraj
Phaniendra Somraj has held a variety of leadership roles in the Medical Device, Aerospace, Micro-Irrigation, Automotive industries as well as Consulting Services. He has global experience in his tenure leading global teams in countries like US, Italy, Romania, China and Australia. He has expertise in Lean Six Sigma principles completing successful Black Belt projects and has written a book to document a “Scientific & Simple Problem Solving Framework (SSPSF)” for problem solving in Enterprises.
What the udemy ISO 13485 – IQOQPQ – Process Validation for Medical Devices course teaches?
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
Installation Qualification (IQ), Operational Qualification (OQ) & Performance Qualification (PQ) || Medical Devices
More information about the course ISO 13485 – IQOQPQ – Process Validation for Medical Devices
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.
