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
Disciplines
Electronics & Embedded Technology Pharmacy Biotechnology View 5 other Short Courses in Pharmacy in IrelandWhat students do after studying
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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/fullTuition FeeBased on the tuition of 139 EUR for the full programme during 1 days. -
National
139 EUR/fullTuition FeeBased on the tuition of 139 EUR for the full programme during 1 days.
Funding
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