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alarm Total duration : 120 minute(s)
Catalog price : €750 (VAT excl.), €900 (VAT incl.)

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

support@immerscio.com

Module Version Level & Date

Module 4 - Version Master Advanced from 18/11/2022

Accessibility & Disability

The courses of this Module meet WCAG standards.