Medical Device Process Validation. ISO 13485. IQ OQ PQ.

Medical Device Process Validation. ISO 13485. IQ OQ PQ., available at $84.99, has an average rating of 4.38, with 30 lectures, 24 quizzes, based on 1414 reviews, and has 5050 subscribers.

You will learn about Understand what Process Validation means for any industry. The course will focus on validation for the life science industry especially the medical device industry. Understand why we need process validation. Understand when we need to validate. Process validation within the medical device industry. Covers ISO 13485, Code of federal regulation (21 CFR section 820), quality system regulation (QSR) Understand the three types of validation. Prospective validation, Concurrent validation and Retrospective validation. Learn what user requirement specification (URS) means. Learn what design qualification means. Learn what Installation qualification (IQ) means which contains the Factory Acceptance Test (FAT) and the Site Acceptance Test (SAT) Learn what an Operational qualification (OQ) is. We will demonstrate an operational qualification. Learn how to demonstrate an Operational qualification (OQ) Learn what a performance qualification (PQ) is. Understand the process capability ratio and the process capability index. How it relates to process validation. Understand the process model, control limits and action limits. How it relates to process validation. Understand the Design of experiments and how this is used in the operational qualification part of process validation. Understand how risk management fits into the validation process. Understand how the ISO standard 14971 is utilised and therefore how risk management is applied. Docs: Validation Master Plan, Validation Plan, Validation Change control, Calibration, Process Validation, Preventive Maintenance, Validation Summary Report. Learn how regulation developed for the life science industry in the U.S. Learn how the regulation developed to include process validation This course is ideal for individuals who are Production Managers. or Supervisors. or Technicans. or Manufacturing Engineers. or Process Engineers. or Quality Engineers. or Research and Development Engineers. or Process and Development Engineers. or Professionals engaged in ISO 9001, ISO 13485, QSR, 21 CFR 820, Six Sigma and Quality Control. or Regulatory Affair professionals or Quality Assurance and Quality Control Professionals. or Students who want to understand about the validation process. or Entrepreneurs who want to develop new products in any industry but especially in the Medical device industry or Small start companies who want to develop new products in any industry but especially in the Medical device industry or This course will benefit any industry that needs to understand process validation. It is particularly useful for Production Managers. or Supervisors. or Technicans. or Manufacturing Engineers. or Process Engineers. or Quality Engineers. or Research and Development Engineers. or Process and Development Engineers. or Professionals engaged in ISO 9001, ISO 13485, QSR, 21 CFR 820, Six Sigma and Quality Control. or Regulatory Affair professionals or Quality Assurance and Quality Control Professionals. or Students who want to understand about the validation process. or Entrepreneurs who want to develop new products in any industry but especially in the Medical device industry or Small start companies who want to develop new products in any industry but especially in the Medical device industry or This course will benefit any industry that needs to understand process validation.

Enroll now: Medical Device Process Validation. ISO 13485. IQ OQ PQ.

Summary

Title: Medical Device Process Validation. ISO 13485. IQ OQ PQ.

Price: $84.99

Average Rating: 4.38

Number of Lectures: 30

Number of Quizzes: 24

Number of Published Lectures: 30

Number of Published Quizzes: 24

Number of Curriculum Items: 54

Number of Published Curriculum Objects: 54

Original Price: $199.99

Quality Status: approved

Status: Live

What You Will Learn

Understand what Process Validation means for any industry.
The course will focus on validation for the life science industry especially the medical device industry.
Understand why we need process validation.
Understand when we need to validate.
Process validation within the medical device industry. Covers ISO 13485, Code of federal regulation (21 CFR section 820), quality system regulation (QSR)
Understand the three types of validation. Prospective validation, Concurrent validation and Retrospective validation.
Learn what user requirement specification (URS) means.
Learn what design qualification means.
Learn what Installation qualification (IQ) means which contains the Factory Acceptance Test (FAT) and the Site Acceptance Test (SAT)
Learn what an Operational qualification (OQ) is. We will demonstrate an operational qualification.
Learn how to demonstrate an Operational qualification (OQ)
Learn what a performance qualification (PQ) is.
Understand the process capability ratio and the process capability index. How it relates to process validation.
Understand the process model, control limits and action limits. How it relates to process validation.
Understand the Design of experiments and how this is used in the operational qualification part of process validation.
Understand how risk management fits into the validation process.
Understand how the ISO standard 14971 is utilised and therefore how risk management is applied.
Docs: Validation Master Plan, Validation Plan, Validation Change control, Calibration, Process Validation, Preventive Maintenance, Validation Summary Report.
Learn how regulation developed for the life science industry in the U.S. Learn how the regulation developed to include process validation

Who Should Attend

Production Managers.
Supervisors.
Technicans.
Manufacturing Engineers.
Process Engineers.
Quality Engineers.
Research and Development Engineers.
Process and Development Engineers.
Professionals engaged in ISO 9001, ISO 13485, QSR, 21 CFR 820, Six Sigma and Quality Control.
Regulatory Affair professionals
Quality Assurance and Quality Control Professionals.
Students who want to understand about the validation process.
Entrepreneurs who want to develop new products in any industry but especially in the Medical device industry
Small start companies who want to develop new products in any industry but especially in the Medical device industry
This course will benefit any industry that needs to understand process validation.

Target Audiences

Production Managers.
Supervisors.
Technicans.
Manufacturing Engineers.
Process Engineers.
Quality Engineers.
Research and Development Engineers.
Process and Development Engineers.
Professionals engaged in ISO 9001, ISO 13485, QSR, 21 CFR 820, Six Sigma and Quality Control.
Regulatory Affair professionals
Quality Assurance and Quality Control Professionals.
Students who want to understand about the validation process.
Entrepreneurs who want to develop new products in any industry but especially in the Medical device industry
Small start companies who want to develop new products in any industry but especially in the Medical device industry
This course will benefit any industry that needs to understand process validation.

This Course is broken into six sections. The objective of the course is to explain process validation in simple terms:

Section 1 will give an introduction to process validation and explain why we need it.

We will discuss the steps we take to decide if we need to validate.

The course focuses on medical device process validation. We will explain the regulation governing process validation within the medical device industry. This will explain how ISO 13485, the FDA Quality system regulation (QSR) and the FDA 21 CFR 820 fit into regulation that governs process validation.

Please remember the course explains process validation so it can benefit people interested in manufacturing in any industry.

This section will explain the 3 different types of validation.

In section 2we will explain how process validation is performed.

We will explain what the user requirement specification is.

We will explain design qualification.

Install qualification will be explained which contains the factory acceptance test and the site acceptance test.

We will explain what an operational qualification is. We will demonstrate an operational qualification.

We will explain what a performance qualification is.

Section 3 will explain what is meant by process capability and how it relates to process validation.

We will understand the process capability ratio and the process capability index.

We will understand the process model, control limits and action limits.

We will understand the Design of experiments and how this is used in the operational qualification part of process validation.

Section 4 Risk Management

We will point out where risk management is required within the medical device regulation.

We will explain how risk management fits into the validation process.

We will summarise how the ISO standard 14971 is utilised and therefore how risk management is applied.

Section 5 Process Validation Documentation

In this section we will understand the documentation which needs to be created in order to complete process validation. We will explain terms as follows:

· Process Validation Documentation.

· Validation Master Plan.

· Validation Plan.

· Validation Change control.

· Calibration within Process Validation.

· Preventive Maintenance within the validation process.

· Validation Summary Report

Section 6 will explain in chronological steps how regulation developed for the life science industry in the U.S. We will study this and understand how the regulation developed to include process validation.

The course will be of great benefit to anybody that really wants to understand process validation in simple terms. It can be a very useful training package for the following disciplines:

· Operations.

· People managers.

· Manufacturing Engineers.

· Process Engineers.

· Quality Engineers.

· Regulatory Affairs.

· Research and development Engineers.

· Process and development Engineers.

· Students who need to really understand process validation in simple terms.

· Entrepreneurs or small medium start-up companies that need to develop and understand the manufacturing process.

Course Curriculum

Chapter 1: Introduction

Lecture 1: Lecture 1 What is Process Validation, why we need it and what is verification.

Lecture 2: Lecture 2 Introduction to Process Validation

Lecture 3: Lecture 3 Decision steps to validate a process

Lecture 4: Lecture 4 Medical Device Regulation within Process Validation

Lecture 5: Lecture 5 Different Types of Process Validation

Chapter 2: Process Validation

Lecture 1: Lecture 6 User Requirement Specification

Lecture 2: Lecture 7 Design qualification

Lecture 3: Lecture 8 Installation Qualification

Lecture 4: Lecture 9 Factory Acceptance Test

Lecture 5: Lecture 10 Site Acceptance Test

Lecture 6: Lecture 11 Operational Qualification

Lecture 7: Lecture 12 An example of an Operational Qualification

Lecture 8: Lecture 13 Performance Qualification

Chapter 3: Section 3 Process Capability

Lecture 1: Lecture 14 Process Capability Part 1 Validation

Lecture 2: Lecture 15 Process Capability Part 2 Validation

Lecture 3: Lecture 16 Process Capability Part 3 Validation

Chapter 4: Section 4: Risk Management

Lecture 1: Lecture 17 Process validation Risk Management

Chapter 5: Section 5 Process Validation Documentation

Lecture 1: Lecture 18 Process Validation Documentation

Lecture 2: Lecture 19 Validation Master Plan Process Validation

Lecture 3: Lecture 20 Validation Plan

Lecture 4: Lecture 21 Validation Change Control

Lecture 5: Lecture 22 Calibration within Process Validation

Lecture 6: Lecture 23 Preventive Maintenance within Validation

Lecture 7: Lecture 24 Validation Summary Report

Chapter 6: Section 6 History of regulation

Lecture 1: Lecture 25 History of Regulation Part 1.

Lecture 2: Lecture 26 History of Regulation Part 2.

Lecture 3: Lecture 27 History of Regulation Part 3

Chapter 7: Section 7 Test Method Validation

Lecture 1: Test Method Validation

Chapter 8: Section 8 Bonus Lecture

Lecture 1: Bonus Lecture

Lecture 2: Lecture 29 Process Validation ISO 9001

Instructors

Martin Conneely
Academic

Rating Distribution

1 stars: 8 votes
2 stars: 24 votes
3 stars: 197 votes
4 stars: 561 votes
5 stars: 624 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!

Menu