course
Sterile Medicinal Products
Sterile Medicinal Products
Sterile Medicinal Products

About the Course

Introduction to this course: 

Understand what sterility means, how it's determined, and the role of the Probability of Nonsterile Unit. Learn about viable microorganisms, bacterial endotoxins, and the depyrogenation process. Distinguish between sterilization and disinfection to ensure a safe, sterile environment in pharmaceutical manufacturing.


Who should attend: 

This course is ideal for pharmaceutical professionals, including quality control and assurance specialists, production managers, GMP auditors, and regulatory affairs personnel. It's also beneficial for cleanroom operators, microbiologists, and chemical analysts involved in drug manufacturing. 


Learning Outcomes: 

By the end of this lesson, you will be able to:

  • Recall the key principles of sterilization and terminology related to sterility assessment.

  • Explain the process of depyrogenation and differentiate it from sterilization and disinfection.


What will I gain: 

Participants will gain a comprehensive understanding of sterilization principles, terminology, and contamination control strategies crucial for pharmaceutical manufacturing. By the end of the course, they will be equipped to apply this knowledge to maintain sterile environments effectively.


Prerequisites: 

Prerequisites for this course include a basic understanding of pharmaceutical and medical device manufacturing processes and terminology.


Additional information: 


Course duration: 00:17:01

Course code/version (effective date): L-106/v1.0 (19/02/2023)

Course Categories

GxP Regulations
Course Progress
Not started
Enroll
Course Outline
  1. Sterile Medicinal Products
    1. Lesson 1: Sterile Medicinal Products. Glossary (Part 1)
    2. Lesson 2: Sterile Medicinal Products. Glossary (Part 2)
  2. Additional resources
    1. Mind map: Sterile Medicinal Products
  3. Survey
    1. Course survey
course
Sterile Medicinal Products
Sterile Medicinal Products
Course Progress
Not started
Enroll

About the Course

Introduction to this course: 

Understand what sterility means, how it's determined, and the role of the Probability of Nonsterile Unit. Learn about viable microorganisms, bacterial endotoxins, and the depyrogenation process. Distinguish between sterilization and disinfection to ensure a safe, sterile environment in pharmaceutical manufacturing.


Who should attend: 

This course is ideal for pharmaceutical professionals, including quality control and assurance specialists, production managers, GMP auditors, and regulatory affairs personnel. It's also beneficial for cleanroom operators, microbiologists, and chemical analysts involved in drug manufacturing. 


Learning Outcomes: 

By the end of this lesson, you will be able to:

  • Recall the key principles of sterilization and terminology related to sterility assessment.

  • Explain the process of depyrogenation and differentiate it from sterilization and disinfection.


What will I gain: 

Participants will gain a comprehensive understanding of sterilization principles, terminology, and contamination control strategies crucial for pharmaceutical manufacturing. By the end of the course, they will be equipped to apply this knowledge to maintain sterile environments effectively.


Prerequisites: 

Prerequisites for this course include a basic understanding of pharmaceutical and medical device manufacturing processes and terminology.


Additional information: 


Course duration: 00:17:01

Course code/version (effective date): L-106/v1.0 (19/02/2023)
Course Outline
  1. Sterile Medicinal Products
    1. Lesson 1: Sterile Medicinal Products. Glossary (Part 1)
    2. Lesson 2: Sterile Medicinal Products. Glossary (Part 2)
  2. Additional resources
    1. Mind map: Sterile Medicinal Products
  3. Survey
    1. Course survey

Course Categories

GxP Regulations
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