Susan Bain, DRScProfessor of Practice, Clinical, Regulatory and Quality; Program Director, MBS in Clinical and Regulatory Affairs
Regulatory Affairs, Quality Assurance, Compliance and Operations
Dr. Bain has a strong background in Regulatory Affairs, Quality Assurance, Compliance and Operations, with more than 25 years of managerial experience at leading pharmaceutical, biotech and medical device firms, as well as at the FDA.
Her corporate experience includes serving as a Vice President in charge of Quality/Regulatory Assurance and Operations at the Huntington Beach-based SpineWorks LLC, a medical device company which focuses on implant design and development, assisting people with complex spine conditions. Prior to that, she was the Manager of Regulatory Affairs and then the Manager of Corporate Quality Assurance at Watson Pharmaceuticals in Corona, CA. Her responsibilities included initiating and coordinating product recalls, ensuring product destruction met FDA guidelines and regulations, post-approval drug manufacturing changes and reporting, and reviewing and submitting labeling per FDA guidelines, among other duties. She also held managerial positions in Quality Assurance and Control and/or Regulatory Affairs at Techniclone Corporation (Peregrine Pharmaceuticals), Baxter Health Care Corporation and Alpha Therapeutic Corporation (Grifols) in Los Angeles.
As a FDA Consumer Safety Officer based in Irvine, she investigated complaints against FDA-regulated products, conducted audit recall checks and monitored compliance to injunctions and seizures. In addition, as a certified medical device investigator, she inspected various pharmaceutical, medical device, IVD and veterinary medicine firms for compliance to all regulations for product licensure and cGMP compliance.
She received a Doctorate of Regulatory Science (DRSc), a Master of Science in Regulatory Science from the University of Southern California (USC) and a Bachelor of Science in Biological Science from Cal Poly, Pomona. She holds a graduate certificate in Effective Supervision from Cal Poly Pomona and is a member of the Orange County Regulatory Association.
This course will provide students with broad general competencies in regulatory affairs for all FDA-regulated product classes (drugs, biologics and devices) throughout the product lifecycle (pre-clinical development, clinical development and post marketing).
This course will provide students with a more in-depth understanding of clinical trial design, conduct and strategy for therapeutic products.
This course examines the operational, strategic and commercial aspects of the regulatory approval process for new medical devices, biologics, and combination products in the United States.
The business environment and regulatory framework pertaining to the medical products industry continue to change rapidly, as they are constantly challenged by competition, politics and new technological possibilities. The highly lucrative and competitive nature of this industry requires professionals have a good working knowledge, background and understanding of FDA's most recent developments, trends and legislation affecting product development, licensing and manufacturing of current and future pharmaceutical products and devices. ALS 463 is a one-credit course that will provide students with a broad background and understanding of the most current regulatory developments, strengthening their capacity to discuss and address contemporary issues effecting the pharmaceutical and medical device industry. The student will become familiar with the challenges posed by recent legislation and enforcement and be better able to analyze, plan and navigate in the dynamic and complex medical products industry.
This course will provide students with a broad background and understanding of the most current European Union regulatory requirements, strengthening their capacity to discuss, perform and address the regulatory requirements effecting licensure of products from the pharmaceutical and medical device industries.
|Susan Bain, DRSc|
|Location:||Building 535, Room 156C|