Learner Outcomes

This Quality and Compliance course provides an overview of quality and productivity management in a pharmaceutical, medical research, and manufacturing setting. It goes into how quality and compliance can be broken down into control and assurance. The concepts are applied to improve the quality of clinical trials and products, the safety of patients, the improvement of data, and the satisfaction of the sponsor and clinical site. It focuses on four pillars of quality, control, assurance, and improvement, while you acquire the background, theory, and analytical tools needed to ensure quality and compliance. At the end, students will participate in a hand-on activity that will involve applying several concepts and theories into an application-based scenario.

Course Objectives

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

Evaluation Method

The evaluation method is in the form of:

• Weekly quizzes
• Group assignment in the form of video or written report (choice of the group)
• Final Exam

Intended For

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

Note:

QCCR110- New required course for Clinical Research Certificate Program as of September 2019.