Introduction to cGMP in Biopharmaceutical Industry

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Taylor Lee

36:07

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1 - Introduction

1 - Introduction.mp4

01:12

2 - Drug Development Process for Biologics.mp4

05:01

2 - Module 1 Background

3 - Background of cGMP Biologics.mp4

03:15

3 - Module 2 Quality Management System QMS

4 - What is QMS in Biomanufacturing.mp4

03:09

5 - QMS Tools You Should Know.mp4

03:14

4 - Module 3 GxP in Biopharmaceutical Industry

6 - Product QbD Part 1Introduction.mp4

02:13

7 - Product QbD Part 2CPP CQA.mp4

01:55

8 - Product QbD Part 3Design of Experiment DoE.mp4

02:09

9 - Product QbD Part 4 Risk Validation PAT.mp4

02:44

10 - GxP Introduction.mp4

01:21

11 - Process Part 1 Aseptic Processing.mp4

01:59

12 - Process Part 2 Good Documentation Practice GDP.mp4

02:02

13 - Premises.mp4

03:58

14 - Personnel.mp4

00:40

15 - Conclusion.mp4

01:15

Description

cGMP, Quality by Design (QbD), aseptic processing, biologics

What You'll Learn?

Comprehensive Understanding and Practical Application of cGMP Principles
Quality by Design and Process validation
Levels of Quality Management Systems
Control strategies
Cleanroom requirements

Who is this for?

This course is designed for individuals aspiring to or currently engaged in the biopharmaceutical industry, seeking a comprehensive understanding of Current Good Manufacturing Practice (cGMP) and its application in ensuring product quality and compliance.

What You Need to Know?

No previous experience required

More details

Description
- Are you an engineer or a scientist who wants to break into the emerging biomanufacturing field?
- Are you an R&D specialist who wants to know more about the bioprocess development and validation?
- Are you working in Market Access or Regulatory Affairs that need to know the language used in cGMP?

If you've answered yes to any of these questions, this course is designed for you! I'm Taylor, with an MEng degree in Biomanufacturing from a World Top 30 university and years of experience in the biopharmaceutical industry, I've launched BioMANU, a channel aimed at disseminating essential knowledge about biomanufacturing. I truly believe that by having more professionals access to cutting-edge processes, we can enhance global biologics supply while reducing costs.
Biologics are shaping the future of pharmaceuticals, making it crucial for professionals to grasp essential cGMP components. Throughout this 30-minute crash course, you will gain insight into vital concepts of cGMP in biomanufacturing. This includes its distinctions from traditional pharmaceutical practices, the quality by design (QbD) framework, environmental monitoring, aseptic processing, process validation, and more. By mastering cGMP principles, it will not only elevate your work standards but also foster seamless communication and collaboration across diverse teams within the industry.
Feel free to explore our demo videos and other courses related to biomanufacturing that we offer. I canâ€™t wait to have you join us!
Who this course is for:
This course is designed for individuals aspiring to or currently engaged in the biopharmaceutical industry, seeking a comprehensive understanding of Current Good Manufacturing Practice (cGMP) and its application in ensuring product quality and compliance.

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Pharmaceutical Industry

Taylor Lee

Instructor's Courses

Hi there! I'm Taylor, thrilled to meet you! With a Master's in Biomanufacturing and years of industry experience,I am glad to bring this introduction to cGMP in biopharmaceutical manufacturing course. Biologics are shaping the future of pharmaceuticals, making it crucial for professionals to grasp essential cGMP components.In this comprehensive online course, we will first introduce the basic background of cGMP and biopharmaceutical manufacturing. Then we will talk about the levels of the quality management system. Our main focus will be module 3 which dives deep into the key concepts in GMP following the 5P framework, which stands for product, people, premises, process, and procedure. Key concepts that will be discussed include aseptic processing, Quality by design (QbD), process validation, cleanroom requirements, control strategies, and more. Let's explore this dynamic industry together.

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