Description

Learner Profile:

Learners who are already in the pharmaceutical sector who wish to increase their knowledge base in Process Validation and/or

learners who are seeking access to the area of Validation.

Learner prerequisites:

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

Candidates are likely to come from a technical background such as science or engineering who wish to upskill in a range of validation processes. 

Learners must have completed the 2-day Introduction to Validation course (AMC22017) prior to commencing this course, if they are new to validation.

Learning outcomes:

On completion of this programme the learner should be able to:

• Understand the importance of process validation in the biopharmaceutical industry.
• Demonstrate an understanding of the regulatory requirements and guidelines related to process validation including the three stages of process validation and how to apply them.
• Understand the concept of designing process validation protocols and related documentation.
• Outline the meaning of “design space”, as it relates to biopharmaceuticals and ensuring the quality and safety of the final product.
• Gain knowledge and insights through real-life case studies.
• Understand the concepts of CPPs (Critical Process Parameters) and CQAs (Critical Quality Attributes) as key measures of a Process Validation study.
• Describe the need for deviation and change management during the process validation cycle.