Contamination Prevention & Control

Description:

Contamination is a serious concern for the pharmaceutical industry. The presence of contaminants such as non-viable particles, micro-organisms and their endotoxins can reduce or even inactivate the therapeutic activity of the drugs and can adversely affect patients taking the contaminated drugs. In this course, we will learn about the basics of contamination and the control measures and strategies to prevent pharmaceutical contamination.

Curriculum for this course:
Introduction
Overview 49 secs
Learning objectives 32 secs
Who should take this course? 1 min 13 secs
Course modules 1 min 01 secs
Module 1: Introduction to Contamination Prevention
Overview 2 mins 05 secs
Why the concern over contamination 1 min 34 secs
Vaccines 1 min 20 secs
Parenteral Medicine 1 min 15 secs
Terms explained 3 mins
Review Activity 5 mins
Module 2: Types of Contamination
Overview 1 min 35 secs
The FDA 2 mins 35 secs
What is contamination? 1 min 23 secs
What is cross contamination? 2 min 10 secs
Types of contamination 1 min 38 secs
Microorganisms 1 min 02 secs
Size of microorganisms 1 min 30 secs
Growing Microbes 56 secs
Different types of microorganisms 1 min 34 secs
Growth of microorganisms 45 secs
Rate of growth of bacteria 1 min 02 secs
Module 3: Sources of Contamination
Overview 2 mins 10 secs
Where does contamination come from? 1 min 20 secs
Sources of contamination 1 min 40 secs
Personnel 1 min 34 secs
Sources of viable contamination 1 min 50 secs
Human hands 33 secs
Skin 25 secs
Proper hand washing 2 mins 05 secs
Building and facility 1 min 50 secs
Equipment 1 min 20 secs
Materials 1 min 55 secs
Manufacturing process 2 min 20 secs
HVAC systems 1 min 25 secs
Modes of cross contamination 2 mins 20 secs
Review Activity 5 mins
Module 4: Quality Risk Management
Overview 2 mins 20 secs
QRM defined 1 min 20 secs
QRM team for contamination prevention 55 secs
ICH Q9 Quality Risk Management – Part 1 1 min 40 secs
ICH Q9 Quality Risk Management – Part 2 1 min 20 secs
FDA focus on risk assessments 2 mins 30 secs
QRM European Commission Insight 1 min 10 secs
Quality risk management tool selection 2 mins 28 secs
FMEA – Contamination preventation 1 min 20 secs
FMEA example 2 min 20 secs
Module 5: Contamination Control Strategies
Overview 1 min 17 secs
Control strategies 2 min 10 secs
Personnel – Part 1 58 secs
Personnel – Part 2 1 min 47 secs
Monitoring methods – people 1 min 20 secs
Gowning 1 min 50 secs
Facility building design – Part 1 1 min 25 secs
Facility building design – Part 2 1 min 48 secs
Facility building design – Part 3 1 min 10 secs
Aseptic facilities 1 min 33 secs
Airlocks 58 secs
Pressure differentials 1 min 44 secs
HEPA Filters 45 secs
Laminar air flow 1 min 10 secs
Heating ventilation and air conditioning (HVAC) system 2 min 17 secs
Manufacturing process 1 min 17 secs
Access to areas 2 min 17 secs
Cleaning and disinfection – Part 1 1 min 30 secs
Cleaning and disinfection – Part 2 1 min 48 secs
Chemical agents 1 min 16 secs
Different type of chemical agents 2 min 48 secs
How to use the chemical agent 1 min 18 secs
Utilities 1 min 50 secs
Water 2 min 17 secs
Sterilization
Sterile equipment
Equipment – Part 1 1 min 57 secs
Equipment – Part 2 2 min 18 secs
Materials 47 secs
Conclusion
Final Assessment
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