ISO 13485 – IQOQPQ – Process Validation for Medical Devices
ISO 13485 – IQOQPQ – Process Validation for Medical Devices, available at $49.99, has an average rating of 4.09, with 9 lectures, 2 quizzes, based on 566 reviews, and has 1711 subscribers.
You will learn about 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 This course is ideal for individuals who are Contract Manufacturers, Director of Quality, Quality Managers, Quality Engineers, Supplier Quality Managers, Supplier Quality Engineers, Internal Auditors, Process Engineers, Process Technicians or Medical Device Industry Quality professionals, Risk Management, FDA 483 responses for Process Validation warning letters or Mechanical Engineering Students; Sterilization, Passivation, Calibration etc. service providers or Medical Devices Start Up or Manufacturing Engineers, Quality Engineers or Supply Chain Management or Indian Medical Device Manufacturers and contractors It is particularly useful for Contract Manufacturers, Director of Quality, Quality Managers, Quality Engineers, Supplier Quality Managers, Supplier Quality Engineers, Internal Auditors, Process Engineers, Process Technicians or Medical Device Industry Quality professionals, Risk Management, FDA 483 responses for Process Validation warning letters or Mechanical Engineering Students; Sterilization, Passivation, Calibration etc. service providers or Medical Devices Start Up or Manufacturing Engineers, Quality Engineers or Supply Chain Management or Indian Medical Device Manufacturers and contractors.
Enroll now: ISO 13485 – IQOQPQ – Process Validation for Medical Devices
Summary
Title: ISO 13485 – IQOQPQ – Process Validation for Medical Devices
Price: $49.99
Average Rating: 4.09
Number of Lectures: 9
Number of Quizzes: 2
Number of Published Lectures: 9
Number of Published Quizzes: 2
Number of Curriculum Items: 11
Number of Published Curriculum Objects: 11
Original Price: $189.99
Quality Status: approved
Status: Live
What You Will 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
- Medical Device Development NPI
- Teach IQ OQ PQ to your teams and collaborate better
- Molding Qualification
- Injection Molding Process Validation
Who Should Attend
- Contract Manufacturers, Director of Quality, Quality Managers, Quality Engineers, Supplier Quality Managers, Supplier Quality Engineers, Internal Auditors, Process Engineers, Process Technicians
- Medical Device Industry Quality professionals, Risk Management, FDA 483 responses for Process Validation warning letters
- Mechanical Engineering Students; Sterilization, Passivation, Calibration etc. service providers
- Medical Devices Start Up
- Manufacturing Engineers, Quality Engineers
- Supply Chain Management
- Indian Medical Device Manufacturers and contractors
Target Audiences
- Contract Manufacturers, Director of Quality, Quality Managers, Quality Engineers, Supplier Quality Managers, Supplier Quality Engineers, Internal Auditors, Process Engineers, Process Technicians
- Medical Device Industry Quality professionals, Risk Management, FDA 483 responses for Process Validation warning letters
- Mechanical Engineering Students; Sterilization, Passivation, Calibration etc. service providers
- Medical Devices Start Up
- Manufacturing Engineers, Quality Engineers
- Supply Chain Management
- Indian Medical Device Manufacturers and contractors
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.
Course Curriculum
Chapter 1: Introduction
Lecture 1: Introduction to the Course
Lecture 2: 483s – FDA Data Analysis
Lecture 3: Manufacturing Scenario
Chapter 2: PREPARATION FOR PROCESS VALIDATION
Lecture 1: Stages of Process Validation
Lecture 2: Quality Inspections to help with Process Validation
Lecture 3: Process Development
Chapter 3: IQ OQ PQ – PROCESS VALIDATION
Lecture 1: Installation Qualification IQ Process
Lecture 2: Operational Qualification OQ Process
Lecture 3: Performance Qualification PQ Process & Recap
Instructors
-
Phaniendra Somraj
ISO 13483 Lead Auditor| Master Black Belt in LSS
Rating Distribution
- 1 stars: 15 votes
- 2 stars: 21 votes
- 3 stars: 102 votes
- 4 stars: 240 votes
- 5 stars: 188 votes
Frequently Asked Questions
How long do I have access to the course materials?
You can view and review the lecture materials indefinitely, like an on-demand channel.
Can I take my courses with me wherever I go?
Definitely! If you have an internet connection, courses on Udemy are available on any device at any time. If you don’t have an internet connection, some instructors also let their students download course lectures. That’s up to the instructor though, so make sure you get on their good side!
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