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Overview
Key module objectives
Master microbiological controls and environmental monitoring to ensure bioproduct quality throughout the manufacturing process.
Target audience
• Collaborators integrating or working in interface with a bioproduction or quality control unit (Technicians and managers of quality control laboratories, operators, and technicians of production areas).
• Support functions in laboratories (maintenance, Quality Assurance, R&D).
• Partners (suppliers, service providers, subcontractors) operating in bioproduction or quality control partners.
• Students in life sciences, analysis and control, pharmacy or chemistry, or individuals from the academic field wishing to understand the industrial environment of biopharmaceutical control.
Module Overview
Activity 1 : Manufacturing and microbiological controls for bioproducts
• Sampling process
• Documentation and traceability
• Best sampling practices
Activity 2 : Description of microbiological controls performed on examples of bioproducts
• Equipment and reagents in the virology laboratory
• Environmental control and microbiological tests
• Raw material quality control tests
Activity 3 : New rapid and automated techniques for environmental monitoring and microbiological bioproducts control
• Introduction to Out of Specification (OOS) and Out of Trend (OOT) results
• Deviation investigation
• Implementation of CAPA (corrective and preventive actions)
Prerequisites
Second year university level
Or equivalent experience in health industry.
Completion of the previous module in the same domain.
Learning mode
Remote
Digital modalities
e-learning
Evaluation procedures
• A short evaluation at the end of the module confirming what you have learnt and enabling you to move to the next one (no limit of attempts, 80% of correct answers required).
• Trainees enrolled in the whole curriculum have the possibility to assess and set their new knowledges and skills via an anchoring quiz between modules.
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
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
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Accessibility & Disability
The courses of this Module meet WCAG standards with the exception of contents in 3D/VR/AR. For those contents, alternatives can be proposed to the Trainee. For any questions or additional information, please contact support@immerscio.com.
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