Process Validation (101) in ISO 9001/Quality/Risk Management

Process Validation (101) in ISO 9001/Quality/Risk Management, available at $44.99, has an average rating of 4.15, with 27 lectures, 6 quizzes, based on 525 reviews, and has 1740 subscribers.

You will learn about Understand and apply the state of the art technique on process validation. Understand when it is necessary, convenient or just an option, to validate a process. Create a User Requirement Document. Create a Master Validation Plan. Create a Validation Protocol. Perform the Equipment Qualification. Perform the Istallation Qualification. Performe the Operational and Performance Qualification. Know when and how to use the retrospective validation. Know when re-validate a process. Better understand the requirements of ISO 9001 or Six Sigma with respect to process validation or process control. Be employed in positions of responsibilities in companies with processes that need validation. Be employed in positions of responsibilities in companies with mass production. Be employed in positions of responsibilities in companies working in regulated fields like aerospace, automotive, pharmaceutical, food, and medical industries. This course is ideal for individuals who are Managers in production industries or Quality Assurance or Quality Control professionals or Quality Engineers or Production Engineers or Entrepreneurs or Process Engineers or Consultants or Managers and Engineers working in aerospace, automotive, pharmaceutical, food, and medical industries or Regulatory Affairs managers and engineers or Professional engaged in ISO 9001 or Six Sigma or Students and people who want to develop their career in one or more of the fields above It is particularly useful for Managers in production industries or Quality Assurance or Quality Control professionals or Quality Engineers or Production Engineers or Entrepreneurs or Process Engineers or Consultants or Managers and Engineers working in aerospace, automotive, pharmaceutical, food, and medical industries or Regulatory Affairs managers and engineers or Professional engaged in ISO 9001 or Six Sigma or Students and people who want to develop their career in one or more of the fields above.

Enroll now: Process Validation (101) in ISO 9001/Quality/Risk Management

Summary

Title: Process Validation (101) in ISO 9001/Quality/Risk Management

Price: $44.99

Average Rating: 4.15

Number of Lectures: 27

Number of Quizzes: 6

Number of Published Lectures: 27

Number of Published Quizzes: 6

Number of Curriculum Items: 33

Number of Published Curriculum Objects: 33

Original Price: $199.99

Quality Status: approved

Status: Live

What You Will Learn

Understand and apply the state of the art technique on process validation.
Understand when it is necessary, convenient or just an option, to validate a process.
Create a User Requirement Document.
Create a Master Validation Plan.
Create a Validation Protocol.
Perform the Equipment Qualification.
Perform the Istallation Qualification.
Performe the Operational and Performance Qualification.
Know when and how to use the retrospective validation.
Know when re-validate a process.
Better understand the requirements of ISO 9001 or Six Sigma with respect to process validation or process control.
Be employed in positions of responsibilities in companies with processes that need validation.
Be employed in positions of responsibilities in companies with mass production.
Be employed in positions of responsibilities in companies working in regulated fields like aerospace, automotive, pharmaceutical, food, and medical industries.

Who Should Attend

Managers in production industries
Quality Assurance or Quality Control professionals
Quality Engineers
Production Engineers
Entrepreneurs
Process Engineers
Consultants
Managers and Engineers working in aerospace, automotive, pharmaceutical, food, and medical industries
Regulatory Affairs managers and engineers
Professional engaged in ISO 9001 or Six Sigma
Students and people who want to develop their career in one or more of the fields above

Target Audiences

Managers in production industries
Quality Assurance or Quality Control professionals
Quality Engineers
Production Engineers
Entrepreneurs
Process Engineers
Consultants
Managers and Engineers working in aerospace, automotive, pharmaceutical, food, and medical industries
Regulatory Affairs managers and engineers
Professional engaged in ISO 9001 or Six Sigma
Students and people who want to develop their career in one or more of the fields above

Process Validation is the most widely used technique in order to guarantee that a process yields the desired outcome over time.

It can be applied to virtually any types of processes, both manufacturing and service processes, and it is often required by international standards (like ISO 9001), and by applicable legislation, like in the medical devices or pharmaceutical field, automotive, food, aerospace, and so on.

Whatever the field, its application can be summarized in few basic steps and tools, whose comprehension enable you to perform almost every Process Validation required in the industry.

In this course, I will guide you through these principles and techniques with plain words and clear examples, so that at the end of the learning experience, you will be able to understand and apply these principles to your field of interest.

This knowledge is valuable both to managers and engineers involved in production processes, quality management, six sigma, and in general in any activity which required that a process yields specific outcomes over time in a reliable way.

Therefore… let us get started!

Course Curriculum

Chapter 1: Introduction

Lecture 1: Introduction

Chapter 2: Planning the Validation

Lecture 1: Introduction to Process Validation

Lecture 2: Master Validation Plan

Lecture 3: Process Validation Protocol

Chapter 3: Equipment Qualification (EQ) and Installation Qualification (IQ)

Lecture 1: Equipment Qualification – EQ – Part 1

Lecture 2: Equipment Qualification – EQ – Part 2

Lecture 3: Installation Qualification – IQ – Part 1

Lecture 4: Installation Qualification – IQ – Part 2

Chapter 4: Statistical tools for Process Validation

Lecture 1: Tendencies: Mean, Median and Modes

Lecture 2: Dispersion: Range, Variance and Standard Deviation

Lecture 3: Dispersion: Standard Deviation in Gaussian Distributions – the 68-95-99 Rule

Lecture 4: Graphs: Dot Plots

Lecture 5: Graphs: Histograms

Lecture 6: Graphs: Box Plots

Lecture 7: Graphs: Pareto Chart

Lecture 8: Control Charts

Chapter 5: Operational Qualification

Lecture 1: Process Yield

Lecture 2: Process CQA

Lecture 3: Process Stability and Capability

Lecture 4: Operational Qualification – OQ – Part 1

Lecture 5: Operational Qualification – OQ – Part 2

Chapter 6: Performance Qualification

Lecture 1: Performance Qualification – PQ

Lecture 2: Out of Control Conditions

Lecture 3: Retrospective, Prospective, and Re-Validation

Chapter 7: Conclusions – Thank you!

Lecture 1: Conclusions – Thank you!

Chapter 8: Bonus Section: Related Courses Coupons

Lecture 1: Bonus Lecture: Related Courses Coupons

Chapter 9: Certificate of Completion

Lecture 1: How to download the Certificate of Completion

Instructors

Marco CATANOSSI
Top 10% Instructor – MSc -CEng – Senior Consultant

Rating Distribution

1 stars: 11 votes
2 stars: 16 votes
3 stars: 112 votes
4 stars: 195 votes
5 stars: 191 votes

Frequently Asked Questions

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