Quality Assurance: The Role of the Quality Assurance (QA) Professional in The Manufacture of Medical Products

By Eileen Ruiz, PhD

Quality Assurance: The Role of the Quality Assurance (QA) Professional in The Manufacture of Medical Products, presents an introduction to the role of the QA personnel in the biomedical industry, focused on the manufacture of pharmaceuticals and medical devices. The content is intended for those interested to work in the Industry and seek guidance about employment alternatives.

The book provides an introduction of the organizational structure and dynamics of working in a regulated manufacturing environment, under quality systems. In general, we present the important elements you need to know about the quality role in the industry. You will gain basic knowledge about quality, quality systems, quality audits, and how to handle non-compliance events.

You will also have an overview of the business and regulatory aspects of the sector.

The e-book content includes an introduction to the following topics:

Introduction to the Biomedical Industry
• Medical Devices and Products
• Pharmaceutical Industry
• Manufacturing

Quality
• Quality Assurance (QA)
• Quality Control
• Quality Unit
• Cost of Quality

Regulatory Environment
• Quality
• Quality Systems
• International Quality Standard: ISO
• Quality audits
• Regulatory Agencies
• Food and Drug Administration (FDA)
• What are GMP's?
• Why do we follow GMP?
• Inspection

Quality Systems Elements
• Design Control
• Materials Control
• Record Control
• Change Control
• Customer Complaints
• Process Performance

Documentation
• Procedures
• Records
• Good Documentation Practices

Quality Audits
• Responses to audits

Roles of the Quality Department
• Quality Assurance (QA)
• Operational Quality
• New Products
• Quality Control
• Laboratories
• Audits
• CAPA
• Documentation
• Training

Additional Roles
• Quality Assurance Professional (QA)
• QA versus QC
• Investigation
• Approval
• Product or Materials Disposition
• Audits
• Metrics and Trends
• Continuous improvement
• Failure investigation
• Training
• Document review

Skills and Knowledge

Conclusion

• Language: English
• Publisher: Lulu.com
• Release date: Dec 27, 2020
• ISBN: 9781716291692

Book preview

Eileen Ruiz Perez, PhD

To God, who opens doors and provides opportunities.

My family for always being there for me.

To my students, for their motivation to learn and inspire me to develop in the field of teaching.

Copyright ©2020 by Eileen Ruiz, PhD and

Biobusiness Research, Inc.

All rights reserved.

This book or any part there of it may not be reproduced or used in any way without the express written permission of the publisher, except for the use of short quotations in a book review.

First edition, December 2020 ISBN: 978-1-716-29169-2

Published independently by Biobusiness Research, Inc.

www.biobusinessresearch.net https://learn.biobusiness.us

Content

Introduction

1,The Biomedical Industry

Medical Devices and Products

Pharmaceutical Industry

Manufacturing

2 Quality

Quality Assurance (QA)

Quality Control

Quality Unit

Cost of Quality

3 Regulatory Environment

Quality

Quality Systems

International Quality Standard: ISO

Quality audits

Regulatory Agencies

Food and Drug Administration (FDA)

What are GMP's?

Why do we follow GMP?

Inspection

4 Quality Systems Elements

Design Control

Materials Control

Record Control

Change Control

Customer Complaints

Process Performance

5 Documentation

Procedures

Procedures

Records

Good Documentation Practices

6 Quality Audits

Responses to audits

7 Roles of the Quality Department

Quality Assurance (QA)

Operational Quality

New Products

Quality Control

Laboratories

Audits

CAPA

Documentation

Training

8 Additional Roles

Quality Assurance Professional (QA)

QA versus QC

Investigation

Approval

Product or Materials Disposition

Audits

Metrics and Trends

Continuous improvement

Failure investigation

Training

Document review

9 Skills and Knowledge

10 Conclusion

References

Quality Assurance

Role of the Quality Assurance (QA) Professional in the Manufacturing of Medical Products

By:  Eileen Ruiz Perez, PhD

Quality Assurance: The Role of the Quality Assurance (QA) Professional in The Manufacture of Medical Products, presents an introduction to the role of the QA personnel in the biomedical industry, focused on the manufacture of pharmaceuticals and medical devices.  The content is intended for those interested to work in the Industry and seek guidance about employment alternatives.

The book provides an introduction of the organizational structure and dynamics of working in a regulated manufacturing environment, under quality systems.  In general, we present the important elements you need to know about the quality role in the industry. You will gain basic knowledge about quality, quality systems, quality audits, and how to handle non-compliance events.  You will also have an overview of the business and regulatory aspects of the sector.

Quality Assurance

Role of the Quality Assurance (QA) Professional in the Manufacturing of Medical Products

Preamble

This book presents an introduction to the role of QA personnel in the biomedical industry, with a focus on manufacturing pharmaceuticals and medical devices.

The topic arises in response to several students who have approached seeking guidance and direction about employment alternatives they may find in this industry.

They are students who are interested in working in the industry once they finish their studies, but they are not clear in which areas they can work. Many times, at the University we are prepared in fundamental classes, however, they do not provide us with direction about other functional areas that are key to day-to-day operation in an industry.

We want to help you be better prepared for job search, understand what career alternatives are, and how you can contribute with your knowledge, and skills to your organization's development and professional development.

It is important that you understand that the industry is a business. These companies are a profit-seeking business to be able to operate, maintain jobs, be able to develop and introduce new products.

The organization can have a service mission, however, to achieve it has to meet economic challenges, maintain finance and account to its shareholders.

If an organization does not work efficiently, controlling costs, and promoting sales, its technologies become obsolete, lose market, profit, and even can disappear. We need to develop the business vision that the industry expects from its employees to achieve operational goals.

There are several metrics that measure us, and we must comply with. Quality, regulatory, are financial, metrics are just a few. We need to know about these topics and understand how we are expected to contribute to the organization. We have to be prepared and speak the terminology that the employer speaks. We must show that we understand their language and take care to know and support the organization.

The biomedical industry is not like any industry. It has a lot of controls. We are manufacturing medicines, food, nutrients, products or services that somehow touch life and can impact a person. Therefore, it has a number of controls and is highly regulated. There are a number of regulations, rules, and standards to follow. Each employee is responsible for following them.

In this book we provide with the basic knowledge in quality and Quality Assurance topics, so that you can understand the concepts and functional areas that are necessary in the