SPRING - UCSC Extension Silicon Valley
SPRING - UCSC Extension Silicon Valley
SPRING - UCSC Extension Silicon Valley
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REGULATORY AFFAIRS Biosciences<br />
Elective Courses: Regulatory<br />
Electronic Records for<br />
Regulated Environments: Cost-Effective<br />
Approaches to Compliance<br />
CMPS.X400.382 (1.5 quarter units)<br />
This interactive two-day course explores proven techniques<br />
for reducing costs associated with implementing,<br />
using, and maintaining computer systems in regulated<br />
environments. The instructor addresses the latest industry<br />
standards for data security, data transfer, and audit trails.<br />
Students see how the FDA regulation pertaining to use<br />
of electronic records and signatures (21 CFR Part 11),<br />
and the HIPAA electronic security regulations for medical<br />
records fit into the validation process. Finally, the instructor<br />
reviews recent FDA inspection trends and discusses<br />
how to streamline SOP production.<br />
This course benefits regulatory, clinical, and IT<br />
professionals working in the health care, clinical trial,<br />
biopharmaceutical, and medical device sectors.<br />
Prerequisite(s): Participants should have good computer<br />
skills and some experience in a GxP environment.<br />
DAVID NETTLETON, A.A.<br />
SANTA CLARA CLASSROOM WITH ONLINE MATERIALS<br />
2 meetings: Friday, 8:30 am–5 pm, June 8;<br />
Saturday, 8:30 am–5 pm, June 9.<br />
Fee: $655 ($65.50 discount for early enrollment).<br />
To enroll, use Section Number 19362.(008)<br />
Post-Market Regulatory Obligations<br />
for Medical Devices<br />
NATSC.X400.044 (1.5 quarter units)<br />
After receiving regulatory approval or clearance within<br />
the United States, a medical device is subject to continuing<br />
regulation in the form of record keeping and reporting<br />
to federal agencies, including the FDA. This course<br />
provides a detailed overview of post-market regulatory<br />
obligations and offers practical insights for efficient and<br />
robust systems that can be implemented prior to market<br />
release. Discussion topics include complaint handling,<br />
adverse event reporting, device tracking, import/export<br />
requirements, and the conduct of mandatory and<br />
voluntary recalls. Other reporting and record keeping<br />
requirements for industry trade organizations and the<br />
Office of the Inspector General will also be discussed.<br />
Prerequisite(s): “Regulation of Medical Devices<br />
and Diagnostics.”<br />
DEBORAH TOLOMEO, J.D., Ph.D., RAC.<br />
THERESA BRANDNER-ALLEN, B.S.M.E., M.S.<br />
SANTA CLARA CLASSROOM<br />
5 meetings: Wednesdays, 6:30–9:30 pm,<br />
May 30–June 27.<br />
Fee: $750 ($75 discount for early enrollment).<br />
To enroll, use Section Number 22414.(005)<br />
Elective Courses: Clinical<br />
Adverse Event and Medication Coding:<br />
An Introduction to MedDRA ® ,<br />
COSTART, and WHO-Drug<br />
For course description, see page 13.<br />
Drug Safety and<br />
Adverse Events Reporting<br />
For course description, see page 14.<br />
Electronic Data Capture for Clinical Trials<br />
For course description, see page 15.<br />
Global Conduct of Clinical Trials<br />
For course description, see page 15.<br />
Good Clinical Practices<br />
For course description, see page 12.<br />
Preparing for FDA Inspections<br />
and Conducting Sponsor Audits<br />
For course description, see page 15.<br />
Science of Clinical Trials Design<br />
For course description, see page 13.<br />
Elective Courses:<br />
Discovery/Development<br />
A maximum of 1.5 units may be applied toward the<br />
elective.<br />
Intellectual Property Essentials<br />
for the Life Science Industry<br />
For course description, see page 10.<br />
Medical Device Design and Development<br />
For course description, see page 11.<br />
Molecular Diagnostics<br />
For course description, see page 11.<br />
Toxicology Basics for Biotechnology<br />
For course description, see page 11.<br />
Also of Interest<br />
Clinical Trials Essentials:<br />
An Intensive Course<br />
For course description, see page 13.<br />
Bioscience Business<br />
Certificate Program<br />
Bioscience Business<br />
and Marketing<br />
NOte<br />
This certificate program is no longer available to new<br />
students. If you have already applied for the certificate<br />
or are currently taking courses in the program and need<br />
more information, e-mail program@ucsc-extension.edu<br />
or call (408) 861-3860.<br />
Early Enrollment Discount<br />
Save 10 percent when you enroll more than<br />
14 days before the first day of class.<br />
VIEW complete course schedules<br />
ONLINE AT <strong>UCSC</strong>- EXTENSION.EDU<br />
ACCESS TO ONLINE MATERIALS<br />
online materials indicates that classroom instruction<br />
is supplemented with online materials or activities.<br />
Students who enroll in these courses, and in those<br />
which are entirely online, will receive logon information<br />
within 24 hours. However, valid logon information<br />
may not be active until the course’s start date.<br />
18<br />
Enroll on our Web site with a credit card. It’s the fastest, easiest way to get started. Visit ucsc-extension.edu.
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