Ms Dunham emphasizes validation in her detailed how-to course on documentation of specifications and testing procedures for equipment or systems processes. You should not copy company files to gain RA expertise, she adds. Ms Cabalza now sits on the ISPE Board as its youngest participant in valuable networking opportunities, and is being encouraged to apply directly to the FDA for her next RA job. Enthusiastically, Ms Cabalza realizes that her use of the UCSD student voucher for the Extension's professional development training in RA has opened a new world of exciting work opportunities. In Biology, of course, you learn about research institutions like Scripps or the Burnham, but most of my classmates bound for med school, think of the lab as just a pit stop on their way.
Trainees often choose to study biotech patent law and related issues in greater depth.
The FDA is seeking a regulated collaboration with industry, wherein the industry contact is viewed as the technical expert on product specifics. Together, the FDA and a company can develop agreements on specific applications of rather general regulations. UCSD preparation helps the RA professional learn how to best characterize, for example, the potency of a novel pharmaceutical. UCSD core courses in regulatory requirements and regulatory compliance are filled with casework to enable trainees to anticipate difficulties and avoid citations, and the elective courses for the Professional Certificate build on these skills. Optimizing use of time and money is critical to the welfare of the patient and the company, particularly of small biotechs, and even of the national economy.