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
Internet access
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.
Overview
Section 1: Introduction
Lecture 1 GMP - Meaning and Overview
Lecture 2 The Main Risks
Lecture 3 GMP Importance
Lecture 4 GMP Directives
Lecture 5 GMP Requirements
Section 2: GMP and the Quality System
Lecture 6 Quality System
Lecture 7 Principle and Overview
Lecture 8 Case Study
Section 3: GMP and Personnel
Lecture 9 Personnel and Principle
Lecture 10 Key and qualified personnel
Lecture 11 Responsibility Distributions
Lecture 12 Staff Training and Hygiene
Section 4: Premises and Equipment
Lecture 13 Production Areas
Lecture 14 Storage Areas
Lecture 15 Quality Control and Ancillary Areas
Lecture 16 Equipment
Section 5: Documentation
Lecture 17 Principle
Lecture 18 Generation, Control and Types of Documentation
Lecture 19 Manufacturing Formula and Processing Instructions
Section 6: Production
Lecture 20 Principle
Lecture 21 Prevention of Cross Contamination in Production
Lecture 22 Starting Materials and Processing Operations
Lecture 23 Packaging Operations
Section 7: Quality Control
Lecture 24 Principle
Lecture 25 QC Tasks
Lecture 26 Technical Transfer of Testing Materials
Section 8: Complaints and Recalls
Lecture 27 Complaints & Recalls
Lecture 28 Complaints
Lecture 29 Classification of Defects
Lecture 30 Recalls
Section 9: GMP Audit
Lecture 31 Considerations for GMP Audit
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


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