Understanding the Life Sciences Industry (Online Course)

Understanding the Life Sciences Industry

Learn how it is to work in the medical products manufacturing industry.

This online, self-paced, introductory course is designed for those interested in a career in the life sciences and biomedical manufacturing industries such as the pharmaceutical, medical devices and biotechnology. The content focuses on individuals who want to understand what it is like to work in the industry.

It is useful for those who are interested to work in the industry, but do not know their organizational structure, or the dynamics of working in a highly regulated manufacturing environment, controlled by quality systems.

This program is designed for those who aspire to start a career or just want to know what it is like to work within a highly regulated industry such as the biomedical or life sciences industry. We will provide a general overview of the industry, with emphasis on the manufacturing of pharmaceutical and medical products. Our goal is to help you understand the main roles and responsibilities and be better prepared for the job search. In general, we will present some of the important elements you need to understand about the industry.

At the end of this course you will learn about medical devices and pharmaceutical products. You will understand the rules that every employee who works in this highly regulated environment should follow. We will discuss some of the careers and functional areas that you can find in this industry. You will get the basic knowledge about quality, quality systems, audits, and non -conformities. In addition, you will have an overview of the business and regulatory aspects related to the sector. It is important that you recognize the international regulations and standards that each employee must follow to ensure that the product, processes and services meet quality standards and are safe to use.

The topics to be addressed include an introduction to the manufacturing industry, quality systems, international quality standards such as ISO, regulations, conformity and non-conformity, quality system audits, and Corrective and Preventive Actions, known as CAPA. The CAPA system is related to investigating the cause of non-conformities and establishing the actions taken to correct the Non-conformity (corrective actions) and what actions are being implemented to prevent non- conformity (preventive actions) from occurring. It is a highly regulated environment. Continually we are being audited by external agencies and internal auditors.

In addition to the regulatory side, there are other concepts that are part of the everyday vocabulary for those who work in this environment. For example, production process controls, how to work in a controlled environment area, contamination control to guarantee the quality of the final product, environmental monitoring of production areas, microbiological quality controls, validations, equipment qualifications, project management, failures and non-conformity investigations, corrective and preventive actions (CAPA), and continuous improvement are just some of the areas of knowledge that are valued in the industry.

It is also important that you know what it is like to work in a clean room or controlled Environment area (CEA). These areas have controls in terms of cleanliness and contamination. The manufacturing environment is continuously monitored through microbiological tests, particle counts, temperature, humidity, differential pressure, and air changes, among others.

Several tests are carried out in the manufacturing areas to determine if complies with quality parameters and specifications. The area is controlled. It must meet the minimum requirements according to the quality standards. This is a little different scenario for those who have not been exposed to contamination controls in the working areas.

At the end of the course, you will have an overview of the role of quality control (QC) laboratories, which perform tests to ensure that the organization processes and products meet quality. Laboratories, such as microbiology and chemistry, are usually part of the quality control function.

The regulatory and compliance area is critical in this type of industry. We must follow the law, quality standards, and Good Manufacturing Practices (GMPs). If we fully follow them, we are in compliance. Compliance is a word that is part of the daily vocabulary in the industry. If we are not in compliance, quality events are generated, observations or audit findings are given, and the company has problems. The quality role is to ensure that all elements of the Organization are in compliance.