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Overview
Key module objectives
Explain the role and the importance of In-Process Controls (IPCs) in DSP, and the interactions between operators and Quality Control teams.
Target audience
Employees from pharma or chemistry, newcomer to pharma sector, people with interest into pharma sector.
Module Overview
Activity 1: Overview of In Process Controls (IPCs) for DSP in cGMPs
• Different types of In Process Controls (IPCs), their roles, advantages and stakes for DSP in cGMPs
• Main IPCs according to methods and roles in the control of product quality profile
• Controls results and potential impacts of deviations on CQAs
• Identification of deviation and suggestion for improvement
• Sampling plan review and suggest actions
• PAT (Process Analytic Technology) initiative and stakes for DSP
Activity 2: IPCs Methods and Equipment for Downstream Process in cGMPs
• Physico-chemical, microbiological and biochemical IPCs at the DSP step
• Sampling procedures and good practices
Activity 3: Identifying and managing deviations, developing a continuous improvement mindset
• IPCs information listed in batch records or procedure documents
• Out-of range controls and reacting accordingly
• Module evaluation quiz
Prerequisites
No prerequisites
Learning mode
Remote
Digital modalities
Activity 1: E Learning / Activity 2: Serious Game 2D / Activity 3: Serious Game 2D
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 (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.
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 & Price
Master Version, 15/09/2023
€750
Accessibility & Disability
The courses of this Module meet WCAG standards.
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