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Overview
Key module objectives
• Define basic microbiology principles
• Differentiate sources and vectors of contamination
• Identify the stakes of an aseptic environment
• Define ISO classes
• Define grades
• Identify basic of gowning
• Describe equipment
and techniques for air purity
• Name gowning and hygiene steps in order, and in accordance with the area to be reached (C,D)
• Perform controls in the correct order (C,D)
Target audience
Employee from pharma or chemistry, newcomer to pharma sector, people with interest into pharma sector…
Module Overview
Activity 1: Identify the stakes of an aseptic environment. Differentiate the contaminants and recognize their risks
• Microbiology basics, sources & vectors of contamination: concept of biocontamination, types of micro-organisms
in the pharmaceutical industry & their potential risks; different sources of contamination
• Stakes of an aseptic environment: risks & consequences of product contamination; identification of the aim of a clean room and responsibilities
of the staff in a clean room
Activity 2: ISO classes and grades. Basics of gowning
• ISO classes : concept and classes table & different levels of contamination control linked to different zones
• Bio
Contamination grades and prerequisites to enter an area; correspondence between grades and ISO classes
• Equipment and techniques of air cleanliness
Activity 3: Identify controls before entrance in low grade area: Gowning and Hygiene steps
In
this learning element, the participant puts into practice what he has covered in the M2LE2 and performs all the necessary steps (gowning and hygiene) to enter a C,D grade area
• Module evaluation quiz
Prerequisites
Complete the module 1 of this curriculum, Essential level
Learning mode
Remote and on site
Digital modalities
Gamified eLearning / Virtual Reality
Evaluation procedures
• A final evaluation at the last module to assess what you have learnt in the curriculum (max. 3 attempts, 80% of correct answers required)
Required equipment
Recommended equipment for an optimal experience : PC computer, with the last version of web browsers Chrome/Firefox/Microsoft Edge, and an internet connection of 8 Mb/s or more. Regarding the virtual reality equipment, please refer to these instructions.
Face to face training
Some activities on this curriculum must be done within an Immerscio Training Center. Please consult the available Immerscio Training Centers and the onsite reservation modalities HERE.
Contact for any question
Module Version Level, Date & Price
Module 2 - Version Master Essential from 18/11/2022
Overview
Key module objectives
• Define bioproduct and biopharmaceutical
• Compare biopharmaceutical and chemical pharmaceutical
• Identify development steps of a biopharmaceutical
• Identify manufacturing steps of a biopharmaceutical
• Identify global regulatory
framework leading to commercialization
Target audience
Employee from pharma or chemistry, newcomer to pharma sector, people with interest into pharma sector…
Module Overview
Activity 1: Bioproducts and biopharmaceuticals
• Definition of bioproducts or biobased products and identification of different sources;
• Presentation of the main differences between bioproduct and biomanufacturing
• Introduction to the 5 main families of bioproducts
• Regulatory
definition of a biopharmaceutical, examples of biopharmaceutical origins
• Presentation of the 3 main types of biopharmaceuticals: Vaccines, Proteins, ATMP
• Short introduction to the regulatory framework of biopharmaceuticals
Activity 2: Development phases, manufacturing steps, and regulatory framework of biopharmaceuticals
• Presentation of the development phase of a biopharmaceutical product (Research, Pre-clinical studies, Clinical production, Clinical trials, Marketing authorization, Price & reimbursement rate)
• Detailed presentation of the 3
main production steps (and their different sub-steps) and illustration via examples: USP, DSP, F&F
• Global presentation of the global regulatory framework leading to commercialization
Activity 3: Jobs in the biopharmaceutical Industry
Learner will play a recruiter who will:
• Place each CV in the right job family
• Practice to position each job in the life cycle of a biopharmaceutical project and chemical pharmaceuticals
• Make interactions between the main
job families (product, control, regulatory & marketing jobs)
• Module evaluation quiz
Prerequisites
No prerequisites
Learning mode
Remote
Digital modalities
Gamified eLearning / Serious Game 3D
Evaluation procedures
• A final evaluation at the last module to assess what you have learnt in the curriculum (max. 3 attempts, 80% of correct answers required)
Required equipment
Recommended equipment for an optimal experience : PC computer, with the last version of web browsers Chrome/Firefox/Microsoft Edge, and an internet connection of 8 Mb/s or more.
Face to face training
Not Applicable
Contact for any question
Module Version Level, Date & Price
Module 1 - Version Master Essential from 18/11/2022
Price upon request
Accessibility & Disability
The courses of this Module meet WCAG standards with the exception of contents in 3D. For those contents, alternatives can be proposed to the Trainee. For any questions or additional information, please contact support@immerscio.com.
Accessibility & Disability
The courses of this Module meet WCAG standards with the exception of contents in virtual reality. For those contents, alternatives can be proposed to the Trainee. For any questions or additional information, please contact support@immerscio.com.
Enroll to this curriculum
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