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Description

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.
Who this course is for:
All food handlers
All food safety team members
QA/QC managers and personnel
Pharmacists
Production managers and personnel
Business owners or any person in charge of food and/or drug manufacturing premises

What you'll learn

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

Requirements

  • You will need a copy of Adobe XD 2019 or above. A free trial can be downloaded from Adobe.
  • No previous design experience is needed.
  • No previous Adobe XD skills are needed.

Course Content

27 sections • 95 lectures
Expand All Sections
1-Introduction
5
1.1-GMP - Meaning and Overview
1.2-The Main Risks
1.3-GMP Importance
1.4-GMP Directives
1.5-GMP Requirements
2-GMP and the Quality System
3
2.1-Quality System
2.2-Principle and Overview
2.3-Case Study
3-GMP and Personnel
4
3.1-Personnel and Principle
3.2-Key and qualified personnel
3.3-Responsibility Distributions
3.4-Staff Training and Hygiene
4-Premises and Equipment
4
4.1-Production Areas
4.2-Storage Areas
4.3-Quality Control and Ancillary Areas
4.4-Equipment
5-Documentation
3
5.1-Principle
5.2-Generation, Control and Types of Documentation
5.3-Manufacturing Formula and Processing Instructions
6-Production
4
6.1-Principle
6.2-Prevention of Cross Contamination in Production
6.3-Starting Materials and Processing Operations
6.4-Packaging Operations
7-Quality Control
3
7.1-Principle
7.2-QC Tasks
7.3-Technical Transfer of Testing Materials
8-Complaints and Recalls
4
8.1-Complaints & Recalls
8.2-Complaints
8.3-Classification of Defects
8.4-Recalls
9-GMP Audit
2
9.1-Considerations for GMP Audit
9.2-Course Assessment