Computer System Validation in Pharmaceutical and Medical Device Domain

This course is designed to guide you through the regulatory, scientific, and practical aspects of validating computerized systems that support GxP processes.

Course Overview and Approach

This course follows a structured, end-to-end approach to provide you with a clear understanding of global regulatory expectations, validation strategy, system qualification, and lifecycle maintenance. You will learn how computerized systems support critical manufacturing, laboratory, and quality operations, and why regulators require these systems to be validated throughout their lifecycle.

The course will explore key areas across the CSV lifecycle, including:

• Building your foundation in CSV, including the modern framework of Computer Software Assurance (CSA).

• Learning about the regulations that drive CSV, such as FDA 21 CFR Part 11, EU Annex 11, ISO 13485, and FDA QSR 820 / QMSR.

• Learning the End-to-End CSV Process Steps.

• Getting introduced to industry-level documentation as part of CSV, such as Validation Plans, URS, FRS, Risk Assessments, and Traceability Matrices.

• Understanding and applying the ALCOA+ principles (Attributable, Legible, Contemporaneous, Original, Accurate, Plus attributes) that underpin data integrity.

• Understanding the GAMP 5 Framework and system categorization (Category 1, 3, 4, 5), which guides the validation effort.

Stay in touch, participate in Q&A and connect with other learners via our community 'Computer System Validation Professionals', Click here to join the community.

We also have weekly live sessions to clear your doubts. Please send your questions in advance to contact@neujinsolutions.com.

Note: The certificate will be shared over email upon successful completion of the course.