Description

Learner Profile:

Learners who are already in the pharmaceutical sector who wish to increase their knowledge base in equipment validation and/or learners who are seeking access to the area of validation and who wish to upskill specifically in equipment validation.

(Candidates are likely to have completed the Introduction to Validation for the Pharmaceutical Industry course (AMC22017), if they are new to 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).

Learners must have completed the 2-day Introduction to Validation course (AMC22017) prior to commencing this course.

Learning outcomes:

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

• Demonstrate a clear understanding of equipment qualification and the V model as a structured approach to validation in the pharmaceutical and biopharmaceutical industries.

• Understand the importance of User Requirement Specifications (URS) including testable criteria for ordering and procuring equipment, ensuring alignment with the validation process

• Recognise the of the importance of requalification and the reasons for requalification, including changes to equipment, processes, or regulatory requirements, and be able to explain why periodic requalification is essential for maintaining product quality and safety

• Demonstrate knowledge of the process of planning and executing Installation Qualification (IQ) and Operational Qualification (OQ) tests, including identifying the testing requirements and executing the necessary protocols.

• Gain knowledge and insights through real-life case studies.