Introduction To Cgmp In Biopharmaceutical Industry
Free Download Introduction To Cgmp In Biopharmaceutical Industry
Published 1/2024
MP4 | Video: h264, 1920x1080 | Audio: AAC, 44.1 KHz
Language: English | Size: 151.36 MB | Duration: 0h 36m
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
Requirements
No previous experience required
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 can't wait to have you join us!
Overview
Section 1: Introduction
Lecture 1 Introduction
Lecture 2 Drug Development Process for Biologics
Section 2: Module 1: Background
Lecture 3 Background of cGMP & Biologics
Section 3: Module 2: Quality Management System (QMS)
Lecture 4 What is QMS in Biomanufacturing?
Lecture 5 QMS Tools You Should Know
Section 4: Module 3: GxP in Biopharmaceutical Industry
Lecture 6 Product: QbD Part 1-Introduction
Lecture 7 Product: QbD Part 2-CPP & CQA
Lecture 8 Product: QbD Part 3-Design of Experiment (DoE)
Lecture 9 Product: QbD Part 4 - Risk, Validation & PAT
Lecture 10 GxP Introduction
Lecture 11 Process Part 1: Aseptic Processing
Lecture 12 Process Part 2: Good Documentation Practice (GDP)
Lecture 13 Premises
Lecture 14 Personnel
Lecture 15 Conclusion
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.
Homepage
https://www.udemy.com/course/introduction-to-cgmp-in-biopharmaceutical-industry/
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