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alarm Total duration : 13 hour(s)

Overview

Main competencies

- Identify key data in the bioprocess lifecycle, from development to production, to address issues and optimize performance.
- Understand information systems (ERP, MES, LIMS…) and international standards (ISA95/ISA88) to structure data models and ensure traceability, compliance, and efficiency.
- Understand "On-premises" and "Cloud" storage architectures and the importance of governance (ALCOA++, 21CFRpart11) and standardization to ensure data quality and usability.
- Utilize data through statistical analyses (control charts, bivariate and multivariate methods) and models (mechanistic, Machine Learning) to anticipate deviations and enhance bioprocess control.

Pedagogical content

Module 1: Bioproduct life cycle data, from development to manufacturing
Module 2: Information system organization in the biopharmaceutical industry
Module 3: What architecture should we use to maximize the value of your bioproduction data?
Module 4: Data governance
Module 5: Statistical tools to describe and analyze process operation
Module 6: Modeling methods to simulate and optimize the process
Module 7: Curriculum evaluation

Target audience

Biotechnology students (Master’s level, engineering school) wishing to gain an initial understanding of the challenges related to data management and analysis in an industrial environment.

Experienced technicians, engineers, and team leaders in Bioproduction, as well as support functions (process monitoring, maintenance, Quality Assurance, Quality Control) wishing to strengthen their skills in process digitalization and data utilization in a cGMP context.

Engineers or data science analysts looking to discover the specificities and application cases in bioproduction.

Expertise level

Not applicable

Prerequisites

Basic scientific and technical knowledge in biology and/or biotechnology, or approximately one year of professional experience in bioproduction or the pharmaceutical industry.

Learning modes

Blended Mode

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) Trainees enrolled on the whole Curriculum will also have the possibility to receive anchoring quiz between modules to help them in the memorization of their new competencies.

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

support@immerscio.com

Curriculum version & date

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Accessibility & Disability

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.

Module 7: Final Assessment

Browse the available module by level