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Overview
Key module objectives
Introduce USP and DSP processes, Quality by Design (QbD) development method and control strategy documentation
Target audience
Employees integrating or working in R&D or bioproduction laboratories (senior technicians, engineers, researchers, managers) wishing to integrate the teams of Process Development and/or Technology Transfer.
Personnel initiated in biotechnology working in support functions (Quality Assurance, Analysis, Regulatory), Partners (suppliers, subcontractors, consultants, CMOs) operating in bioproduction and pharmaceutical industry or Public from the academic environment wishing to understand the industrial environment and development issues, the technology transfer and biomedecine production.
Module Overview
Activity #1: Principles and specificities of USP and DSP processes and basis of the Quality by Design (QbD) approach
• Upstream and downstream in Development phase
• Development objectives
• Quality by Design methodology
Activity #2: Key steps for the Quality by Design approach (QbD)
• The parameters for a process characterization
• How to determine a Design Space?
Activity #3: The USP and DSP development documentation for the global control strategy
• USP & DSP development documentation
• Synthesis of the principles of Quality by Design
Prerequisites
Basic scientific and technical knowledge in biology and/or biotechnology or professional experience of approximately 1 year in R&D or pharmaceutical production.
Learning mode
Remote
Digital modalities
Activity 1: E Learning / Activity 2: Serious Game 2D / Activity 3: 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
Gold Version from 10/07/2024
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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