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Introduction to Validation for the Pharmaceutical Industry

This course aims to help learners understand the regulatory requirements related to validation practices and documentation, to ensure consistent high-quality pharmaceutical products. The module will provide the core foundational knowledge and understanding of the fundamental principles and concepts related to including key set protocols of IQ (Installation Qualification), OQ (Operational Qualification), PQ (Process Qualification). Learners will also gain knowledge related to validation document

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Description

Learner Profile:

Learners who are already in the pharmaceutical sector who wish to upskill in Validation skills and/or
Learners who are seeking access to the field of Validation and who wish to gain an understanding of the importance of Validation in the pharmaceutical industry.

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).

Learning outcomes:

On completion of this module, learners will be able to: -

  • Describe the validation lifecycle.
  • Demonstrate knowledge and competence related to the V model* for equipment qualification.
  • Demonstrate an awareness of regulatory responsibility of a manufacturing organization in relation to validation.
  • Understand the CAPA process regarding validation studies.
  • Understand the key concepts and protocols related to the IQ, OQ and PQ validation steps.


Course Content:

• The lifecycle approach to drug development processes and validation.


• Introduction to the key set of protocols within equipment validation (IQ, OQ, PQ).


• V Model for Validation


• Validation Master Plan


• Validation Documentation


• CAPA (Corrective Action Preventive Action)

Duration:

2 Day 

Exam/Continuous Assessment details:

Short Exercise/Quiz (to check for understanding – not marked)

Certification/ Awarding Body/ Credits:

Vendor Certificate of Completion

Progression Pathway:

Possible options for progression form this course are as follows:


Certificate in Operational Excellence (Special Purpose Award/QQI Level 6 – 25 Credits: AMC22150) or


Certificate in Supply Chain (Special Purpose Award/QQI Level 6 – 25 Credits: AMC22151)