Quality management systems are essential in the pharmaceutical industry to enhance product quality and reduce the risk of recalls. The Pharmaceutical Quality Management System (QMS), guided by ICH Q10, forms the foundation for quality production and reliable data generation. Gaining knowledge of QMS equips students to excel in quality and management roles within the pharma sector.
This program covers a range of topics including various types of quality management systems, principles of quality management, ISO standards, CAPA management, policy management, and internal auditing.
Program Modules
Module 1 introduces different types of quality management systems, document control, change control, enterprise and operational risk management, supplier management, equipment and asset management, CAPA management, policy management, and internal audit.
Module 2 focuses on the principles of quality management, quality systems, and the elements affecting pharmaceutical quality.
Module 3 explores ISO standards, customer focus, leadership approaches, engagement of members, process approaches, system improvements, evidence-based decision making, and relationship management.
Module 4 covers QMS processes, implementation, and process mapping.
Module 5 highlights QMS tools, risk management, and includes a case study.
Learning Outcomes
Upon completing this course, students will be able to identify, develop, and implement quality management systems, improve processes and systems, eliminate defects, investigate deviations, collaborate effectively with inspectors, prepare for and respond to inspection comments, conduct gap analyses, and perform self-inspections.
Job Opportunities
Graduates of this program can pursue roles as coordinators, auditors, supervisors, or managers within pharmaceutical quality management.
Who Should Attend
This training is suitable for beginners aspiring to become technical writers, existing technical team members, management personnel, auditors, and consultants aiming to deepen their knowledge of pharmaceutical quality management systems.
