Understanding the Life Sciences Industry by Biobusiness Research

Understanding the Life Sciences Industry

Working in the Medical and Pharmaceutical Products Manufacturing Industry

Course Description

This introductory course is designed for students, recent graduates and those interested in starting a career in the life sciences and biomedical products 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. 

This basic course is designed 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.

 
OBJECTIVES

Learn about the dynamics of manufacturing industries in the areas of ​​biotechnology, pharmaceutical, and medical devices.

Understand the rules that each employee must follow.

Know about the regulatory environment in which products are manufactured (FDA, GMP, ISO)

Learn about careers and functional areas within the industry.

Obtain basic knowledge about quality, validations, audits, nonconformities, CAPA, and Project Management.

This mini-course provides an overview of the business aspects related to the life sciences manufacturing industry.

 

TOPICS

 
  • Introduction to the manufacturing industry with an emphasis on biotechnology, medical devices and pharmaceuticals

  • Careers in the Industry

  • Quality Systems / Quality Assurance / Quality Control (QS / QA / QS)

  • Quality Audits

  • Learn about manufacturing operations and support areas.

Language:  English

What's included?

Video Icon 12 videos File Icon 6 files Text Icon 25 text files

Contents

1.0 - Welcome to the Course
1.1 - Welcome to the Course!
1.2 - Why this Course?
1.3 - Course Introduction
1.4 - Introduction to the Course
4 mins
2.0 - Life Sciences Industry Overview
2.1 - The Life Sciences and Biomedical Industry Sectors
2.2 - An Overview of the Life Sciences Industry
7 mins
2.3 - Life Sciences Workforce
3.0 - Manufacturing Operations
3.1 - Manufacturing Operations
3.2 - Manufacturing Operations
5 mins
3.3 - Manufacturing Operations (Handout)
843 KB
4.0 - Functional Areas and Departments
4.1 - Departments
2 mins
4.2 - Functional Roles
3 mins
4.3 - Functional Areas and Departments
5.0 - Quality
5.1 - Quality
5.1.a. - Quality (Handout)
809 KB
5.2. - Quality Systems
5.2.a - Quality Systems (Handout)
624 KB
5.3 - Quality Assurance
5.4 - Quality Assurance (QA)
1 min
5.5 - Quality Department Function
6.0 - Regulatory Environment
6.1 - Regulatory Environment
6.2 - Regulatory Environment.mp4
14 mins
6.3 - Food and Drug Administration (FDA)
6.3.a. What are GMP?
6.3.b. - Regulatory Environment (Handout)
762 KB
6.4 - Regulatory Agencies
6.5 - International Quality Standard: ISO
6.6 - Regulatory Inspections and Audits.mp4
4 mins
6.7 - Quality Audits
7.0 - Documentation
7.1 - Documentation I
3 mins
7.2 - Documentation II
2 mins
7.3 - Documentation
7.4 - Documentation (Handout)
628 KB
8.0 - Knowledge and Skills
8.1 - Knowledge and Skills
6 mins
8.2. - Your Knowledge and Skills
9.0 - Validations
9.1 - Validations
9.2 - Validation (Handout)
428 KB
10.0 - Projects
10.1 - Projects
11.0 - Laboratories
11.1 -Laboratories
12.0 - Course Conclusion
12.1 - Closing of the Course
1 min
12.2 - Conclusion
13.0 - References
13.1 - Common Acronyms in the Industry
13.2- References