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alarm Total duration : 90 minute(s)
Catalog price : €750 (VAT excl.), €900 (VAT incl.)

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

support@immerscio.com

Module Version & Date

Master Version, 15/09/2023

Accessibility

The courses of this Module meet WCAG standards.