Published 5/2025
MP4 | Video: h264, 1280x720 | Audio: AAC, 44.1 KHz, 2 Ch
Language: English | Duration: 4h 14m | Size: 1.95 GB
Master GMP regulations, build a robust QMS, and ensure product quality with practical tools and proven best practices.
What you'll learn
Interpret global GMP regulations and standards to ensure manufacturing compliance with FDA, EMA, WHO, and PIC/S guidelines.
Develop and implement a Quality Management System (QMS), including document control, policies, roles, and continuous improvement processes.
Apply Quality Risk Management (ICH Q9) by conducting risk assessments and implementing mitigation strategies across product lifecycles.
Design and validate cleaning, sanitation, and change control procedures to maintain contamination control and facility hygiene.
Requirements
Basic knowledge of manufacturing or quality assurance principles; familiarity with standard operating procedures (SOPs); access to a computer with an internet connection; no specialized tools required.
Description
Dive deep into the core principles of Good Manufacturing Practice (GMP) and establish a robust Quality Assurance (QA) foundation for your organization. This comprehensive, hands-on course will guide you through global regulatory frameworks, Quality Management Systems (QMS), essential operational elements, and strategies for continuous improvement.You'll start by understanding the origins and purpose of GMP, exploring key regulations from FDA, EMA, WHO, and PIC/S. Next, you'll learn how to design and implement a comprehensive QMS that includes document control, organizational roles, standard operating procedures (SOPs), and process oversight. You'll gain the skills to develop quality policies, manage change control processes, and maintain rigorous documentation and record-keeping to ensure audit readiness.Building on this foundation, the course dives into critical operational elements: personnel and training programs, facility design and environmental controls, equipment qualification (IQ/OQ/PQ), and materials and supplier management. You'll master contamination control by designing validated cleaning and sanitation procedures, understand how to conduct in-process checks, and ensure consistent product quality through effective production and process control. Laboratory and quality control modules will provide practical insights into sampling techniques, analytical methods validation, and data integrity within electronic systems compliant with 21 CFR Part 11.Risk management is at the heart of GMP. You will apply ICH Q9 principles to identify potential risks, assess severity and probability, and implement tailored mitigation strategies. We'll cover deviation management, root cause analysis, and Corrective and Preventive Action (CAPA) workflows, equipping you to resolve nonconformances and drive continuous improvement. Hands-on exercises will help you develop audit checklists, conduct internal audits, and prepare for regulatory inspections with mock inspections and readiness assessments.Finally, the course addresses supply chain and distribution controls, including vendor qualification, cold chain logistics, serialization, and traceability best practices. You'll learn how to manage product complaints and recall procedures to protect end users and maintain brand reputation. Throughout the course, real-world case studies, interactive quizzes, and downloadable templates such as SOP checklists, risk assessment matrices, and audit planning guides will reinforce your learning and enable immediate application in your workplace.Interactive video demonstrations will show you how to conduct environmental monitoring, calibrate equipment, and execute batch record reviews step-by-step. You will receive personalized feedback through optional community Q&A sessions and peer discussions to reinforce your learning journey.You'll also learn to leverage continuous improvement methodologies like Lean, Six Sigma, and the PDCA cycle to optimize processes and track key performance indicators. Upon completion, you will gain a verified certificate of completion to showcase your expertise and advance your professional credentials.Note: This course is based on publicly available GMP guidelines and is not affiliated with any regulatory agency.By the end of this course, you'll have the confidence and competence to implement and manage a fully compliant GMP system. Whether you're a quality assurance professional, manufacturing engineer, regulatory affairs specialist, or lab technician, this course will empower you to elevate product safety, ensure regulatory compliance, and foster a culture of quality excellence in your organization.Enroll now to transform your quality assurance processes and become a GMP expert!
Who this course is for
Quality assurance professionals, manufacturing engineers, regulatory affairs specialists, and quality control personnel in pharmaceutical, biotech, and medical device industries seeking to master GMP principles and implement a robust QMS.
Homepage:
https://www.udemy.com/course/good-manufactoring-practices-gmp-mastery/Screenshots
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