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Introduction to Validation for the Pharmaceutical Industry

The aim of this course is to assist learners to understand the regulatory requirements related to validation practices and documentation in order to ensure consistent high-quality 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, OQ, PQ. Learners will also gain knowledge related to validation documentation.

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Description

Learner Profile:

Candidates must have Leaving Certificate Maths or equivalent

What You Will Get:

    • 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.

Course Modules:

Module 1


The lifecycle approach to drug development processes and validation.


Module 2


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


Module 3


V Model for Validation


Module 4


Validation Master Plan


Module 5


Validation Documentation


Module 6


CAPA




Duration

2 Day Onine 

Certification:

Innopharma Education Certificate of Completion


Digital Badge Available