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Overview
Main competencies
• Identify the main steps of USP biological production
• Be able to conduct the main general steps of USP for biological products, in cGMPs
• Identify production equipment and devices
• Operate in Controlled Atmosphere Zones​
• Apply cGMPs guidelines for USP in cGMPs
• Identify USP steps in the context of cGMPs objectives, recognize different USP manufacturing techniques and their impact on the product, the manufacturing process, costs and the environment
• Recognize and adopt the correct behaviors applied to USP in cGMPs to guarantee personal and environmental safety, and product quality
• Identify key in-process controls (IPCs) for USP in cGMPs and recognize various methods for performing key controls
• Apply Data Integrity requirements to USP procedures and report non-compliance
• Perform representative actions of fundamental steps of USP in cGMPs, and alert in case of anomaly or deviation
Pedagogical content
Module 1: Impact of bioproduction on the biotherapy delivery
Module 2: Presentation of cGMPs and industrial environment - USP
Module 3: Behaviors for USP in cGMPs industrial environment
Module 4: In-Process Controls (IPCs) for USP
in cGMPs
Module 5: Data Integrity applied to USP in cGMPs
Module 6: Practice USP in cGMPs
Module 7: Final evaluation
Target audience
Manufacturing operator, supervisor and manager, Production process analyst, continuous improvement technician and engineer, Cell culture engineer…
Expertise level
Essential and Advanced
Prerequisites
• For Essential : some experience in Health Care or curriculum "Environment of Bioproduction Factory" Essential level completed
• For Advanced : some experience in Health Care including supervision and analysis skills or curriculum "USP in cGMPs" Essential
level completed
Learning modes
Remote and face to face (only for the VR)Â
Evaluation procedures
• 1 Evaluation at the end of each
module to be able to access the next module (no limit of attempts, 80% of
correct answers required)
• 1 Evaluation at the last module to validate the
Curriculum (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
Curriculum Version & Date
Master Version, 18/11/2022
Accessibility
The courses offered by Immerscio meet WCAG standards with the exception of contents in 3D, in virtual reality or augmented reality. 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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