This intermediate course provides an in-depth examination of Quality Management System (QMS) in the pharmaceutical, biopharmaceutical, and medical devices industries. The course is designed to address the need for a working knowledge of designing and developing a strong and compliant quality system. The course will cover topics such as Quality Assurance (QA) and Quality Control (QC) concepts, Quality Risk Management (QRM), and Quality by Design (QbD). Students will gain an understanding of the regulatory requirements and guidelines for QMS, including current Good Manufacturing Practices (cGMP) and ISO standards.
Through case studies and student workshops, students will develop practical skills in using quality management tools such as change management, failure investigation, laboratory control system, validation system, and stability program. The course will also cover process validation, equipment qualification, and cleaning validation.
Upon completion of the course, graduates will have a sound and applicable knowledge of QMS and will be able to perform their job responsibilities confidently. This course is suitable for individuals who have a basic understanding of GMP and are looking to expand their knowledge and skills in QMS in order to advance their careers in the life sciences industry.