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Overview
Key module objectives
Know the key principles of GMP, identify HSE and energy constraints, and apply problem-solving methods to address production deviations, regardless of your role (USP, DSP, Fill & Finish).
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: The Bioproduction Environment
• Current Good Manufacturing Practices (cGMPs)
• Hygiene, Safety, and Environment (HSE)
Activity #2: Help the Production Manager in managing safety and quality events - part 1
• First deviation: Acid projection
• Second deviation: Conductivity out of specifications
Activity #3: Help the Production Manager in managing safety and quality events - part 2
• Third deviation: Non-conforming chromatography elution profile
• Fourth deviation: Contamination at the inoculum stage
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 3D / Activity 3: Serious Game 3D
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.Â
Contact for any question
Module Version Level, Date & Price
Gold Version from 28/01/2025
Price upon request
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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