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Overview
Key module objectives
Validate analytical methods and ensure data integrity in quality control throughout the bioproduct 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 : Analytical methods validation
• Lifecycle of analytical method validation
• Concepts and parameters of method validation
• Importance of validation
Activity 2 : Implementation of a method validation protocol
• Analytical method validation process
• Validation strategy and test plan
• Managing deviations during validation
Activity 3 : Data Integrity in Quality Control
• Principles of data integrity (ALCOA+)
• Data management and lifecycle
• Applying data integrity principles
Prerequisites
Second year university level
Or equivalent experience in health industry
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
Master version from 25/07/2024
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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