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

Description

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 2 we 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.

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.

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