This training program offers a thorough overview of Pharmaceutical Quality System (PQS) lifecycle management as defined in ICH Q10. It builds foundational knowledge step by step, covering the history, objectives, and regulatory framework of ICH Q10. The curriculum examines management responsibilities, quality governance, and the four main PQS elements: Process Performance and Product Quality Monitoring, Corrective and Preventive Action (CAPA), Change Management, and Management Review. Participants will learn to apply these elements throughout the product lifecycle, from development and technology transfer to commercial manufacturing and product discontinuation. The program also addresses Knowledge Management and Quality Risk Management as essential support for science- and risk-based decision-making.
This training program references the following global regulatory frameworks and guidelines:
This program is for pharmaceutical professionals in quality assurance, regulatory affairs, manufacturing, process development, technology transfer, and quality system management. It also suits those looking to deepen their knowledge of lifecycle quality management, including leaders responsible for implementing, maintaining, or improving a Pharmaceutical Quality System in their organization.
Learners who successfully complete the program will receive a dated, traceable certificate that provides verifiable proof of their achievement for professional records.
We provide training programs designed to help you meet quality and compliance standards. Our courses cover GMP, GLP, GCP, GEP, GDP, and Quality Assurance.
