Description

Course Aim:

The aim of this course is to provide learners with knowledge and understanding of the use of Process Analytical Technologies for the Biopharmaceutical Manufacturing Sector. The programme will focus on technologies and techniques for applying PAT to a process, regulatory background and the benefits and drivers for the use of PAT.

Learner Profile:

Candidates should at minimum have completed the Junior Cert with pass grades in at least five ordinary level subjects (including Maths and Englsih)

What you will get:

On completion of this programme the learner should be able to demonstrate a knowledge and understanding of:

· What PAT is and why PAT is used in a manufacturing process.
· Regulations pertaining to the use of PAT
· Principles of Quality by Design (QbD), building quality into a process and Quality Risk Management (QRM)
· Deciding when PAT is used, mapping a process for PAT identification
· Commonly applied PAT techniques for measuring physical, chemical and biological properties in biopharmaceutical processes including model based soft sensor and instrument based.
· The learner will also demonstrate basic understanding of principle of spectroscopy measurement and how spectroscopy PAT instruments are used in industry such as Raman, NIR, UV-Vis, FTIR and other commonly used methodologies.

Course Modules:

• PAT and its use in manufacturing processes
• Regulatory implications and requirements with respect to PAT
• Mapping processes for PAT
• PAT techniques
• QbD – Quality by Design
• QRM – Quality Risk Management.