What you'll learn

Understand the importance of proper personnel and material flows, as well as how to design and manage laboratory and production environments to prevent risks
Understand and apply the fundamental principles of Good Manufacturing Practices in your daily operations.
Have a deeper awareness of how to maintain product quality, prevent contamination and mix-ups, and ensure the integrity of all documentation
Proficient in documenting and handling data, ensuring accuracy and traceability in compliance with the ALCOA principles.

Requirements

The course is for student or professional in the pharmaceutical field in order to learn or improve their skills.

Description

In this course, we will provide a comprehensive introduction to Good Manufacturing Practices (GMP) in the pharmaceutical industry. Whether you're new to GMP or looking to refresh your knowledge, this course will guide you through the critical principles and best practices that ensure high-quality, compliant manufacturing processes.We will begin by exploring the origins of GMP, its creation, and the objectives it seeks to achieve. You will learn why GMP standards are essential for maintaining product safety and quality in the pharmaceutical industry. Following that, we will dive into the importance of personnel within a pharmaceutical company, focusing on the role of each individual in maintaining high GMP standards. A key part of this will be understanding the difference between contamination and mix-ups—two issues often confused—and how to effectively prevent and control both in a GMP-compliant environment.Next, we'll examine the expectations for health, dressing, and behavior according to GMP guidelines. This includes understanding personal hygiene, appropriate attire, and workplace conduct, all critical to maintaining a sterile and safe environment. We'll then discuss the management of personnel and materials within the facility, covering best practices to ensure efficiency and prevent contamination risks.The course will also cover GMP

Requirements

for equipment design, cleanliness, and maintenance, emphasizing the importance of equipment validation and preventive maintenance. Afterward, we will explore GMP standards for the Quality Control Laboratory, focusing on how contamination and mix-ups can occur in a lab setting and the distinct consequences of these issues in comparison to production environments.Finally, we'll address the importance of proper documentation and record-keeping within GMP compliance. We will focus on Data Integrity, explaining how to ensure accurate and compliant records across all stages of the manufacturing process.This course is ideal for pharmaceutical industry professionals seeking a deeper understanding of GMP, quality assurance, and regulatory affairs professionals, as well as beginners interested in GMP compliance in regulated environments.

Overview

Section 1: Introduction
Lecture 1 Introduction
Lecture 2 Agenda
Section 2: The course
Lecture 3 GMP: Good Manufacturing Practices
Lecture 4 GMP structure
Lecture 5 GMP goals
Lecture 6 Personnel part I
Lecture 7 Personnel Part II
Lecture 8 Soft skills
Lecture 9 From theory to practise
Lecture 10 Training
Lecture 11 Contamination vs mix-up
Lecture 12 How to prevent mix-up
Lecture 13 Types of contamination
Lecture 14 Risk containment actions
Lecture 15 Health and Igiene
Lecture 16 Transition from dirty to clean areas
Lecture 17 Material flows
Lecture 18 Equipments
Lecture 19 Detergent,disinfectant, sanitizers
Lecture 20 Disinfectant effects
Lecture 21 Quality Control
Section 3: Data Integrity
Lecture 22 GMP documentation and Data Integrity
Lecture 23 ALCOA
Lecture 24 Data Integrity
Lecture 25 From theory to practise
Lecture 26 Conclusions
Quality Assurance, Quality Control or Production employee or students.
Homepage:

https://www.udemy.com/course/good-manufacturing-practices-gmp-knowledge/