Mô tả

Good Manufacturing Practice or GMP is a set of quality assurance practices promoted by regulatory authorities (including the WHO and US FDA) to ensure manufacturing processes are rigorously set and monitored. This training is designed to help you implement into an organization the increasing legislation and guidance on goods within the manufacturing industry.

GMP compliance is widely-accepted as the best way to conduct business, putting product quality first. The course is aimed principally at personnel occupying supervisory and management roles who need detailed explanation of GMP, requirements of GMP and how it works. The GMP course will also be of benefit anyone in the manufacturing (including food, food packaging and food packaging manufacturing) and pharmaceutical industries who have had no significant GMP training previously.

At the end of this course, you will be able to review general and specific requirements for documentation and records, review the way in which a self-inspection programs should be carried out, discuss aspects of good practices in production and quality control. You will understand the roles and duties of key personnel and departments in GMP implementation (i.e. production and quality personnel), and the importance of personnel training to GMP. You will learn best practices in complaints and recalls handling, self-inspection and quality audits. You will learn and be able to apply key considerations for GMP audit.

Bạn sẽ học được gì

Meaning and importance of GMP in the manufacturing and pharmaceutical industries.

GMP principles and key requirements

Aspects of good practices in production/manufacturing

Aspects of good practices in quality control

General and specific requirements for documentation and records

The role of Production, Quality Control (QC), Quality Assurance (QA) and the Qualified Person (QP) in GMP

Will be able to handle complaints and recalls

You'll learn key considerations in GMP auditing

Yêu cầu

  • Internet access

Nội dung khoá học

9 sections

Introduction

5 lectures
GMP - Meaning and Overview
04:03
The Main Risks
00:32
GMP Importance
00:59
GMP Directives
00:52
GMP Requirements
02:45

GMP and the Quality System

3 lectures
Quality System
00:17
Principle and Overview
02:54
Case Study
03:12

GMP and Personnel

4 lectures
Personnel and Principle
01:20
Key and qualified personnel
02:48
Responsibility Distributions
04:07
Staff Training and Hygiene
03:01

Premises and Equipment

4 lectures
Production Areas
03:18
Storage Areas
01:27
Quality Control and Ancillary Areas
01:29
Equipment
01:44

Documentation

3 lectures
Principle
00:45
Generation, Control and Types of Documentation
02:13
Manufacturing Formula and Processing Instructions
05:52

Production

4 lectures
Principle
01:48
Prevention of Cross Contamination in Production
00:59
Starting Materials and Processing Operations
02:22
Packaging Operations
03:58

Quality Control

3 lectures
Principle
01:54
QC Tasks
04:58
Technical Transfer of Testing Materials
02:19

Complaints and Recalls

4 lectures
Complaints & Recalls
00:32
Complaints
01:45
Classification of Defects
03:44
Recalls
02:06

GMP Audit

2 lectures
Considerations for GMP Audit
06:49
Course Assessment
8 questions

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