Contamination Prevention and Control in a GMP Environment
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Download 2024 UPDATE:
This program is currently unavailable for enrollment.
It may have been updated or discontinued.
Check for newer version in our catalog.
This program is currently unavailable for enrollment.
It may have been updated or discontinued.
Check for newer version in our catalog.
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Free Trial CoursesOutline:Introduction Overview Learning objectives Who should take this course? Course modules Introduction to Contamination Prevention Overview Why the concern over contamination Vaccines Parenteral Medicine Terms explained Review Activity Types of Contamination Overview The FDA What is contamination? What is cross contamination? Types of contamination Microorganisms Size of microorganisms Growing Microbes Different types of microorganisms Growth of microorganisms Rate of growth of bacteria Sources of Contamination Overview Where does contamination come from? Sources of contamination Personnel Sources of viable contamination Human hands Skin Proper hand washing Building and facility Equipment Materials Manufacturing process HVAC systems Modes of cross contamination Review Activity Quality Risk Management Overview QRM defined QRM team for contamination prevention ICH Q9 Quality Risk Management - Part 1 ICH Q9 Quality Risk Management - Part 2 FDA focus on risk assessments QRM European Commission Insight Quality risk management tool selection FMEA - Contamination preventation FMEA example Contamination Control Strategies Overview Control strategies Personnel - Part 1 Personnel - Part 2 Monitoring methods - people Gowning Facility building design - Part 1 Facility building design - Part 2 Facility building design - Part 3 Aseptic facilities Airlocks Pressure differentials HEPA Filters Laminar air flow Heating ventilation and air conditioning (HVAC) system Manufacturing process Access to areas Cleaning and disinfection - Part 1 Cleaning and disinfection - Part 2 Chemical agents Different type of chemical agents How to use the chemical agent Utilities Water Sterilization Sterile equipment Equipment - Part 1 Equipment - Part 2 Materials Conclusion Final Assessment Certification | Objectives:Skill Level: Basic This training program has been developed to train employees with Basic Knowledge of Contamination Control and Aseptic Techniques. | |
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