Introduction to cGMP in Biopharmaceutical Industry

Introduction to cGMP in Biopharmaceutical Industry, available at $19.99, has an average rating of 4.08, with 15 lectures, based on 6 reviews, and has 19 subscribers.

You will learn about Comprehensive Understanding and Practical Application of cGMP Principles Quality by Design and Process validation Levels of Quality Management Systems Control strategies Cleanroom requirements This course is ideal for individuals who are 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. It is particularly useful 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.

Enroll now: Introduction to cGMP in Biopharmaceutical Industry

Summary

Title: Introduction to cGMP in Biopharmaceutical Industry

Price: $19.99

Average Rating: 4.08

Number of Lectures: 15

Number of Published Lectures: 15

Number of Curriculum Items: 15

Number of Published Curriculum Objects: 15

Original Price: $79.99

Quality Status: approved

Status: Live

What You Will 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 Should Attend

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.

Target Audiences

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.

– 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 can’t wait to have you join us!

Course Curriculum

Chapter 1: Introduction

Lecture 1: Introduction

Lecture 2: Drug Development Process for Biologics

Chapter 2: Module 1: Background

Lecture 1: Background of cGMP & Biologics

Chapter 3: Module 2: Quality Management System (QMS)

Lecture 1: What is QMS in Biomanufacturing?

Lecture 2: QMS Tools You Should Know

Chapter 4: Module 3: GxP in Biopharmaceutical Industry

Lecture 1: Product: QbD Part 1-Introduction

Lecture 2: Product: QbD Part 2-CPP & CQA

Lecture 3: Product: QbD Part 3-Design of Experiment (DoE)

Lecture 4: Product: QbD Part 4 – Risk, Validation & PAT

Lecture 5: GxP Introduction

Lecture 6: Process Part 1: Aseptic Processing

Lecture 7: Process Part 2: Good Documentation Practice (GDP)

Lecture 8: Premises

Lecture 9: Personnel

Lecture 10: Conclusion

Instructors

Taylor Lee
Instructor at Udemy with a MEng in Biomanufacturing

Rating Distribution

1 stars: 0 votes
2 stars: 0 votes
3 stars: 2 votes
4 stars: 2 votes
5 stars: 2 votes

Frequently Asked Questions

How long do I have access to the course materials?

You can view and review the lecture materials indefinitely, like an on-demand channel.

Can I take my courses with me wherever I go?

Definitely! If you have an internet connection, courses on Udemy are available on any device at any time. If you don’t have an internet connection, some instructors also let their students download course lectures. That’s up to the instructor though, so make sure you get on their good side!

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