Pharmaceutical Quality Systems

Course Description This course gives a practical understanding of how pharmaceutical quality systems are built, implemented and maintained across the product lifecycle. It explains the expectations set by global regulatory bodies and connects them with real operational activities like documentation, deviations, CAPA, change control, validation and audit readiness. Learners will explore the core elements of ICH Q10, along with supporting guidelines such as ICH Q8, Q9 and Q12, to understand how quality works not just as a compliance requirement but as a framework for consistency, patient safety and continuous improvement. By the end of the program, participants will be able to apply quality principles in day-to-day work and contribute meaningfully to a culture of compliance and operational excellence. Learning Objectives / Outcomes By the end of this course, participants will be able to understand the structure and purpose of a pharmaceutical quality system and apply regulatory expectations in practical workplace scenarios. They will learn how to manage documentation, deviations, CAPA and change controls in alignment with global standards. They will also gain confidence in reviewing batch records, supporting audits, identifying risks and contributing to continuous improvement initiatives. The course will strengthen their ability to work within GMP environments and support activities across development, manufacturing, testing and lifecycle management. Target Audience 1) Gradua

Module 1: Introduction
Module 2: Introduction to PQS
Module 3: Regulatory Framework
Module 4: Quality Management System Components
Module 5: Product Lifecycle Quality
Module 6: Risk Management
Module 7: Operational Excellence
Module 8: Data Integrity and Digital Compliance
Module 9: Global Inspection and Audit Prepardnes
Module 10: Case Studies and Industry Application