Receive an overview of quality and productivity management in pharmaceutical, medical research and manufacturing settings and learn how quality and compliance control and assurance are applied to help improve:

• Quality of clinical trials and products
• Safety of patients
• Improvement of data
• Satisfaction of the sponsor and clinical site

The course focuses on four pillars of quality, control, assurance and improvement. Learners acquire the background, theory and analytical tools to ensure quality and compliance. At the end, learners will participate in a hands-on activity to apply several concepts and theories into an application-based scenario.

This course is intended for all health professionals interested in clinical research.

Upon successful completion of the course, learners will be able to:

• Understand and apply principles of quality and compliance to a clinical trial involving the clinical site, pharmaceutical company, healthcare workers, health authorities and patients
• Understand the impact to delaying and ignoring quality control and assurance
• Develop a Quality Management System using risk-based management techniques and apply it to different scenarios – GMP and clinical trials
• Understand the role of audits in ensuring quality and compliance
• Review how to conduct an audit successfully
• Understand the differences in quality and regulators between biological products and medical devices