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Overview
Key module objectives
• Identify the types of IPC, characteristics and implementation in cGMPs
• Recognize different approaches & methods to realize physiochemical, microbiological and biochemical IPCs in cGMPs
• Carry-out different IPCs (physiochemical, microbiological, biochemical) in cGMPs and understand impact of potential gaps on process or product quality
• Analyze IPCs results and react accordingly
Target audience
Engineers, manufacturing managers or supervisor, operators qualified for complex USP operations with analytic skills
Module Overview
Activity 1: Overview of In Process Controls (IPCs) for USP in cGMPs
• Reminders on IPCs for USP in cGMPs
• Key IPC technologies
Activity 2: IPCs in Practice
• Check equipment conformity
• Recognizing cell viability
• Identifying out of range results
• Checking sampling calculations
• Checking sampling conformity
Activity 3: Acting on Deviations and Developing a Continuous Improvement Mindset
• Use cases
• Module evaluation quiz
Prerequisites
Complete the modules 1, 2 and 3 of this curriculum, advanced level, or having knowledge of USP
Understand the in-line process control principle
Learning mode
Remote
Digital modalities
E-learning / Serious Game
Evaluation procedures
• A final evaluation at the last module to assess what you have learnt in the curriculum (max. 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
Not Applicable
Contact for any question
Module Version Level & Date
Module 4 - Version Master Advanced from 18/11/2022
Accessibility
The courses of this Module meet WCAG standards.
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