The life science industry is regulated by governmental agencies, including the U.S. Food and Drug Administration (FDA) and the Environmental Protection Agency (EPA). Industry professionals must have a working knowledge of the regulatory environment in which they work and a commitment to repeatedly producing safe, effective and reliable products.
Regulatory Affairs professionals ensure that companies are in compliance with these governing authorities. The Regulatory Affairs Professional Society (RAPS) provides career information and resources at their website, along with information about RAC certification. In California regional groups such as Orange County Regulatory Affairs (OCRA) and San Diego Regulatory Affairs Network (SDRAN) provide training and education programs and networking to help professionals advance their careers.
While many college science graduates understand concepts surrounding repeatability, they don’t necessarily know that there is an entire body of knowledge employed to ensure safety of pharmaceuticals and medical device products, even at the discovery stage (Chemistry, Manufacturing & Control, or CMC). The American Society of Quality (ASQ) Biomedical Division provides training and education programs and networking opportunities to help professionals advance their careers.
CSU Dominguez Hills
Bachelor and Master of Science in Quality Assurance (BSQA and MSQA)
CSU Dominguez Hills provides baccalaureate and graduate level quality assurance programs to professionals in a variety of industries. CSU Dominguez Hills partnered with the biotechnology industry to adapt its coursework to more closely align with industry practice. The online Bachelor of Science in Quality Assurance (BSQA) degree program blends the basic sciences with the technologies, management principles, quality concepts and statistical tools needed to prepare professionals for careers in Quality Assurance, and to enhance the careers of working professionals in the field seeking career enhancement. The online Master of Science in Quality Assurance (MSQA) degree program is designed to prepare professionals in quality, engineering, science, management, health care, government and service industries for career advancement. Topics covered include Total Quality Management (TQM), Six Sigma, ISO 9000, reliability, benchmarking, process improvement, quality control, human factors in quality assurance, measurement and testing techniques, quality project management, productivity, quality function management, and customer satisfaction.
San Diego State University
Regulatory Science Programs
Since 1999 Regulatory Science Programs at San Diego State University have provided online education and training to enhance professional excellence and career opportunities for scientists in the pharmaceutical, biotechnology and medical device industries, and other professionals who are broadening their skill-set or making a career change. Regulatory science professionals are in demand. A career in regulatory affairs can take many paths, e.g., clinical trials, drug development, food safety, medical device advancement, pharmaceutical research, or chemistry manufacturing and controls. Just knowing the fundamentals of regulatory affairs is not enough to advance your career or secure a job in this industry. To become a regulatory affairs professional, training and education are essential. Students in our fully online Masters Degree and Certificate Programs build a foundation of knowledge focused on current laws, regulations, and good manufacturing processes mandated by major governmental regulatory agencies, specifically the Food and Drug Administration (FDA) and European Medicines Agency (EMA). Topics related to the discovery, development, testing, manufacture, commercialization, and post-marketing surveillance of pharmaceutical, biologic, and medical device products are at the core of these programs.
All of the Regulatory Science courses are available online as nine-week special sessions and designed to afford students a high degree of flexibility in integrating their studies with their professional responsibilities and other commitments.
For more information visit program website.
San Francisco State University
Clinical Trials Design & Management
The College of Extended Learning offers a series of courses and a professional development certificate in clinical trials design and management. Individuals who pursue a Clinical Trials Design & Management certificate are professionals, often with advanced degrees, working in science, health care, technology, or management. Students may complete a full certificate or simply take those courses which advance their own professional goals. The Program is designed to be flexible for working adults by offering evening or weekend courses.
For more information visit the program website.
San Jose State University
Master of Medical Products Development Management
The Master of Medical Product Development Management (MPDM) is a Master of Science (MS) degree program that prepares its graduates for career change, advancement or entry into the challenging and rewarding field of clinical research and clinical development in the biomedical industry.The emphasis of the program is on the management of products undergoing clinical research and clinical development, i.e. clinical trial stages I, II, III and IV or other testing as required the Federal Food and Drug Administration (FDA).The MPDM provides rigorous courses covering the processes, regulated by the FDA, by which drugs, biologicals such as vaccines and biopharmaceuticals, in vitro medical diagnostics, and medical devices are developed for use in patients. The MPDM also includes advanced MBA-level courses in the administration, supervision and management of the development processes including FDA submissions for medical product approvals.
For more information visit the program website.