Process Validation 1 - Process Design, Certificate | Part time online | National Institute For Bioprocessing Research and Training (NIBRT) | Ireland
1 days
Duration
139 EUR/full
139 EUR/full
Unknown
Tuition fee
Anytime
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Apply date
Anytime
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About

Process Validation 1 -  Process Design from NIBRT Online Academy (NOA) is aimed at individuals who require an overview knowledge of Process Validation and Design – for example, personnel in manufacturing, quality, validation, engineering, and statistics.

Overview

Process Validation 1 -  Process Design from NIBRT Online Academy (NOA) provides an overview of the process design stage of process validation, describing how a biopharmaceutical manufacturing process can be defined using a Quality by Design (QbD) approach that emphasizes accumulated scientific knowledge and Quality Risk Management (QRM).

Process Qualification and Control are covered in e-lesson “Process Validation 2” which will be available soon.

Students at Process Validation 1 -  Process Design from NIBRT Online Academy (NOA) will be able:

  • To describe the rationale for having a structured approach to Process Design.
  • To explain what is meant by the term ‘Quality by Design’.
  • To explain the concept of a ‘Quality Target Product Profile’.
  • To define Critical Quality Attribute (CQA) and provide some examples.
  • To explain why risk assessment is done as part of process design.
  • To explain the concept of a manufacturing ‘design space’ with reference to Design of Experiments and Critical Process Parameters.
  • To define Process Control Strategy and Operational Control Strategy.
  • To define Master Production Record and explain its relationship to Process Design studies.

Programme Structure

Courses include:

  • Process Validation 
  • Process Design

Key information

Duration

  • Part-time
    • 1 days

Start dates & application deadlines

You can apply for and start this programme anytime.

Language

English

Delivered

Online

Academic requirements

We are not aware of any specific GRE, GMAT or GPA grading score requirements for this programme.

English requirements

We are not aware of any English requirements for this programme.

Other requirements

General requirements

  • NOA courses can be accessed through a Desktop Browser or a Mobile App.  
  • The “Go.Learn” Mobile App can be downloaded from the Apple Store or in Google Play.  
  • If you are using a tablet, you can use either the Go.Learn app or you can access the desktop version via your mobile browser

Tuition Fee

To always see correct tuition fees
  • International

    139 EUR/full
    Tuition Fee
    Based on the tuition of 139 EUR for the full programme during 1 days.
  • National

    139 EUR/full
    Tuition Fee
    Based on the tuition of 139 EUR for the full programme during 1 days.

Funding

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Our partners

Process Validation 1 - Process Design
National Institute For Bioprocessing Research and Training (NIBRT)
Process Validation 1 - Process Design
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National Institute For Bioprocessing Research and Training (NIBRT)

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