Good Manufacturing Practices – QMS, Premises & Personnel

Description:

In this course we will discuss why we need to adhere to good manufacturing practices from a Quality Management System perspective, we will discuss GMP in relation to production, storage and quality control areas and also the special precautions for certain types of drugs and materials and finally we will learn about the requirements for working in a manufacturing facility in terms of personal hygiene and what garments should be worn.

Curriculum for this course:
Introduction
Overview 1 min 21 secs
Learning objectives 2 min 31 secs
Who should take this course? 1 min 42 secs
Program introduction 1 min 59 secs
Module overview 43 secs
Module 1: Quality Management System
Overview 2 min 38 secs
What is quality management? 2 min 28 secs
Standard operating procedures (SOP's) 1 min 19 secs
Quality objective 35 secs
GMP as a part of quality assurance 2 min 09 secs
Requirements for an effective quality assurance program 2 min 30 secs
ICH Q10 1 min 35 secs
Life cycles phases of GMP 2 min 01 secs
Module 2: Premises
Overview 2 min 38 secs
Premises 1 min 01 secs
Production areas 2 min 48 secs
Changing rooms 1 min 42 secs
Storage areas 2 min 18 secs
Quality control areas 1 min 51 secs
Module 3: Personnel
Overview 2 min 18 secs
Personnel 2 min 00 secs
General principles 1 min 11 secs
Special requirements for staff 2 min 41 secs
Grades A,B,C and D 1 min 43 secs
Personal hygiene 2 min 52 secs
General considerations for manufacturing 1 min 36 secs
Review Activity 5 mins
Conclusion 2 mins 30 secs
Conclusion
Final Exam
Certification
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