Biotechnology has created more than 200 new therapies and production levels now routinely exceed metric tons for many antibodies. Product complexity has also increased as stem cell therapies have entered clinical studies and the first antilogous cellular therapies have recently been approved in the United States. In turn, ensuring product quality has grown in importance and complexity. Instances of product recalls and regulatory enforcement actions are frequent and result in supply shortages and significant loss of corporate reputation and value. Production of biotechnology products requires comprehensive quality standards and systems that meet global cGMP expectations and are based upon thorough scientific knowledge of the product and process.
Persons knowledgeable in the principles and practice of biopharmaceutical quality management are in high demand and hold positions of significant responsibility within the private and public sectors of the healthcare industry. The primary goal of this course is to provide students with an advanced background in the principles and requirements of biopharmaceutical quality assurance and control. Through a series of lectures and case studies this course will teach the critical thinking and judgment skills that are needed for the development of quality systems and the resolution of product quality issues.
ALS 333 or Instructor approval.
-By the end of this course the student will understand the scientific and regulatory basis for quality assurance and quality control in the biopharmaceutical industry.
– Students will be prepared for entry professional roles in biopharmaceutical quality control through instruction in specifications establishment, stability requirements, in-process control and microbial control of biopharmaceutical processes.
– Students will also be prepared for roles in quality assurance through instruction in the ICH Quality Guidance and international GMP’s. Students will understand the fundamental concepts of product quality investigations, validation, and corrective/preventative actions.
– Students will learn the authority of, and how to interact with, regulatory agencies; with particular emphasis on inspection management and resolution of product quality issues.
– Last, students will understand roles and responsibilities of quality management positions through instruction in regulatory expectations for management, industry best practices, and case studies of management failures in quality.