Biopharmaceutical Quality Assurance and Control
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. Professionals 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 develop the critical thinking and judgment skills that are needed for the development of quality systems and the resolution of product quality issues.
Introduction to US FDA and European Laws and Regulations
This course will provide students with broad general competencies in regulatory affairs for all US FDA regulated product classes (drugs, biologics and devices) throughout the product lifecycle (pre-clinical development, clinical development and post marketing). Emphasis will be placed on regulatory interactions, submissions, other communications and inspections, for each product class and for each phase of the product lifecycle. European regulations will also be reviewed.
CMC Regulations of Pharmaceuticals
Regulatory Chemistry, Manufacturing and Control (CMC) requirements determine the strategy parameters for new pharmaceutical process development and changes post approval. Knowledge of CMC requirements and relevant agencies is a key success factor in pharmaceutical approval and compliance. In particular, globalization has caused a significantly more complex regulatory environment for the manufacture and distribution of pharmaceuticals (and medical devices). Most product supply chains are now multinationals with an increasing trend towards investment in rapidly developing but poorly regulated nations.
The development of regulatory strategies for product development and post approval changes require the understanding of many national regulatory agencies and international harmonization efforts. Often the introduction of product production and distribution improvements is limited by the effectiveness of the Chemistry, Manufacturing and Control (CMC) regulatory strategy employed by the firm.
Effective CMC organizations coordinate with global regulatory agencies to develop risk-based approaches to inspection frequency and focus. Similar risk-based approaches are developed with global regulatory agencies to detect and prevent counterfeiting and product diversion.
Professionals knowledgeable in the principles and practice of regulatory CMC requirements 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 regulatory CMC including Post-Approval reporting requirements, Deviation reporting, Inspection coordination and resolution, and Good Distribution Practices (GDP) practices. Through a series of lectures and case studies, this course will teach the critical thinking and judgment skills that are required for the development of CMC regulatory strategies and influence.