ALS418 - Biopharmaceutical Quality Assurance and Control

This course is taught by Vince Anicetti. He's an adjunct professor at KGI and until recenlty was Vice President for Biologics Quality at Genentech. Currently he's a  Fellow, Science and Regulatory Affairs at the Parental Drug Association.
Here are parts of the course description.

The objective of ALS 418 is to provide students with a board understanding of the scientific and regulatory principles needed for quality assurance and quality control in the biopharmaceutical industry. ALS 418 will provide a through understanding of the following quality roles and responsibilities in the biopharmaceutical industry.

• Provide understanding of the structure of the quality unit and regulatory responsibilities of quality assurance and control organizations.
• Provide an understanding of relevant regulatory agencies and other organizations that set regulations and standards for the biopharmaceutical industry. Instruct students in the requirements and principles of the ICH Quality Guidelines and Good Manufacturing Practices.  
• Help students to develop the logic and critical thinking skills to make product quality and GMP decisions.
• Provide an understanding of best practices in developing and managing Pharmaceutical Quality Systems.
• Convey the expectations and responsibilities of Quality leadership in the Biopharmaceutical Industry based on regulations as well as case studies in management of product quality problems

LEARNING OBJECTIVES:

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, student will be prepared for management positions in biopharmaceutical quality through instruction in regulatory expectations for management, industry best practices, and case studies of management failures in quality.

COURSE FORMAT:

The course is taught using lecture presentations of scientific principles, quality concepts, and relevant regulations. In addition most lectures will feature a case study highlighting quality failures in the biopharmaceutical industry and their consequences. These case studies will be used as learning opportunities to understand fundamental quality concepts and systems and where management lapsed.

Each class session will be 80 minutes. The first part of the class will be lecture followed by time for discussion. Reading assignments for each lecture will be reviewed the week before and will also be posted in your SAKAI folder. Reading assignments will consist of material found on assigned websites. There are no textbooks for this class.

There will be periodic homework assignments and a mid-semester group poster presentation.

COURSE MATERIALS:

Course reading materials will be found online. The course will be structured on the International Conference on Harmonization (ICH) Quality Guidelines, which can be found on www.ich.org. Additional reading assignments will be based on FDA, EMA, or other regulatory guidances and publications. Case study background research will be found in lecture preparation material.