SPRING - UCSC Extension Silicon Valley

More documents

Recommendations

Info

REGULATORY AFFAIRS Biosciences Elective Courses: Regulatory Electronic Records for Regulated Environments: Cost-Effective Approaches to Compliance CMPS.X400.382 (1.5 quarter units) This interactive two-day course explores proven techniques for reducing costs associated with implementing, using, and maintaining computer systems in regulated environments. The instructor addresses the latest industry standards for data security, data transfer, and audit trails. Students see how the FDA regulation pertaining to use of electronic records and signatures (21 CFR Part 11), and the HIPAA electronic security regulations for medical records fit into the validation process. Finally, the instructor reviews recent FDA inspection trends and discusses how to streamline SOP production. This course benefits regulatory, clinical, and IT professionals working in the health care, clinical trial, biopharmaceutical, and medical device sectors. Prerequisite(s): Participants should have good computer skills and some experience in a GxP environment. DAVID NETTLETON, A.A. SANTA CLARA CLASSROOM WITH ONLINE MATERIALS 2 meetings: Friday, 8:30 am–5 pm, June 8; Saturday, 8:30 am–5 pm, June 9. Fee: $655 ($65.50 discount for early enrollment). To enroll, use Section Number 19362.(008) Post-Market Regulatory Obligations for Medical Devices NATSC.X400.044 (1.5 quarter units) After receiving regulatory approval or clearance within the United States, a medical device is subject to continuing regulation in the form of record keeping and reporting to federal agencies, including the FDA. This course provides a detailed overview of post-market regulatory obligations and offers practical insights for efficient and robust systems that can be implemented prior to market release. Discussion topics include complaint handling, adverse event reporting, device tracking, import/export requirements, and the conduct of mandatory and voluntary recalls. Other reporting and record keeping requirements for industry trade organizations and the Office of the Inspector General will also be discussed. Prerequisite(s): “Regulation of Medical Devices and Diagnostics.” DEBORAH TOLOMEO, J.D., Ph.D., RAC. THERESA BRANDNER-ALLEN, B.S.M.E., M.S. SANTA CLARA CLASSROOM 5 meetings: Wednesdays, 6:30–9:30 pm, May 30–June 27. Fee: $750 ($75 discount for early enrollment). To enroll, use Section Number 22414.(005) Elective Courses: Clinical Adverse Event and Medication Coding: An Introduction to MedDRA ® , COSTART, and WHO-Drug For course description, see page 13. Drug Safety and Adverse Events Reporting For course description, see page 14. Electronic Data Capture for Clinical Trials For course description, see page 15. Global Conduct of Clinical Trials For course description, see page 15. Good Clinical Practices For course description, see page 12. Preparing for FDA Inspections and Conducting Sponsor Audits For course description, see page 15. Science of Clinical Trials Design For course description, see page 13. Elective Courses: Discovery/Development A maximum of 1.5 units may be applied toward the elective. Intellectual Property Essentials for the Life Science Industry For course description, see page 10. Medical Device Design and Development For course description, see page 11. Molecular Diagnostics For course description, see page 11. Toxicology Basics for Biotechnology For course description, see page 11. Also of Interest Clinical Trials Essentials: An Intensive Course For course description, see page 13. Bioscience Business Certificate Program Bioscience Business and Marketing NOte This certificate program is no longer available to new students. If you have already applied for the certificate or are currently taking courses in the program and need more information, e-mail program@ucsc-extension.edu or call (408) 861-3860. Early Enrollment Discount Save 10 percent when you enroll more than 14 days before the first day of class. VIEW complete course schedules ONLINE AT UCSC- EXTENSION.EDU ACCESS TO ONLINE MATERIALS online materials indicates that classroom instruction is supplemented with online materials or activities. Students who enroll in these courses, and in those which are entirely online, will receive logon information within 24 hours. However, valid logon information may not be active until the course’s start date. 18 Enroll on our Web site with a credit card. It’s the fastest, easiest way to get started. Visit ucsc-extension.edu.
SPRING 2012 Business and Management In This Section Accounting...................................................... 20 CPA Preparation............................................ 22 Administrative and Executive Assistant....... 23 Bookkeeping Certified Bookkeeper Program....................... 24 Business Administration................................ 24 Graduate School Preparation......................... 26 Executive Education Silicon Valley Business Leadership.................. 26 Financial Planning Personal Financial Planning............................ 27 Human Resources Human Resource Management...................... 29 Strategic Human Resources............................ 31 Instructional Design and Delivery................... 31 Legal Studies Paralegal–Core.............................................. 32 Paralegal–Advanced...................................... 32 Marketing Management................................. 33 MCLE Credit..................................................... 35 Project Management Project and Program Management (PPM)....... 81 Advanced Applied Project Management......... 83 Technical Writing and Communication.......... 35 Web Content Management............................. 37 Course Readers, Textbooks and Other Instructional Resources Students are responsible for obtaining the required instructional materials for all courses. A variety of media are used. Please review the section details at the bottom of the course description pages on our Web site. Instructors may specify any of the following: • Printed course readers from our on-demand service provider, Content Management Corporation (CMC) • Electronic course materials from our online learning platform, UCSC Extension Online • Textbooks (required and recommended). See pages 5 and 94 and visit ucsc-extension.edu/bookstore. • Other materials distributed via e-mail either by the Academic Department or the instructor Students should acquire or access their materials prior to the first class meeting. For full instructions, go to ucsc-extension.edu/course-materials. Copyright © 2012 The Regents of the University of California. All Rights Reserved. 19
Page 1 and 2: SPRING COURSES START WEEKLY IN SANT
Page 3 and 4: New Year, New Options Dean Lynda M.
Page 5 and 6: Biosciences........................
Page 7 and 8: New to UCSC Extension Start Here We
Page 9 and 10: Biosciences Bioinformatics Bioinfor
Page 11 and 12: Biotechnology Certificate Program B
Page 13 and 14: Intellectual Property Essentials fo
Page 15 and 16: Biosciences Clinical Trials SANTA C
Page 17 and 18: Electronic Data Capture for Clinica
Page 19: Biosciences REGULATORY AFFAIRS Requ
Page 23 and 24: Business and Management Accounting
Page 25 and 26: Administrative and Executive Assist
Page 27 and 28: Business and Management Business Ad
Page 29 and 30: For 20 years, UCSC Extension’s pr
Page 31 and 32: Human Resources Certificate Program
Page 33 and 34: HUMAN RESOURCES Business and Manage
Page 35 and 36: Marketing Certificate Program Marke
Page 37 and 38: MCLE Credit MBA in Brief for Attorn
Page 39 and 40: Web Content Management Certificate
Page 41 and 42: Online Teaching Certificate Program
Page 43 and 44: Education Instructional Design and
Page 45 and 46: Education Early Childhood Education
Page 47 and 48: Education Educational Therapy Prere
Page 49 and 50: Education Teaching English to Speak
Page 51 and 52: Education Institute for the Study o
Page 53 and 54: Engineering and Technology Hardware
Page 59 and 60: Engineering and Technology Network
Page 61 and 62: Engineering and Technology Linux/UN
Page 63 and 64: Engineering and Technology Linux/UN
Page 65 and 66: Engineering and Technology Software
Page 71 and 72:
Engineering and Technology Software
Page 73 and 74:
Engineering and Technology Software
Page 75 and 76:
Engineering and Technology Web and
Page 77 and 78:
Engineering and Technology Technolo
Page 79 and 80:
Environmental Health and Safety Env
Page 81 and 82:
Environmental Health and Safety Cli
Page 83 and 84:
Project Management PROJECT AND PROG
Page 85 and 86:
Project Management PROJECT AND PROG
Page 87 and 88:
Spring 2012 Department interstate b
Page 89 and 90:
ONLINE COURSES Engineering and Tech
Page 91 and 92:
SprING 2012 Department interstate b
Page 93 and 94:
SPrING 2012 Department interstate b
Page 95 and 96:
Page 97 and 98:
Page 99 and 100:
instructor biographies ized in the
Page 101 and 102:
instructor biographies the Signal C
Page 103 and 104:
Page 105 and 106:
inDex Microeconomics, Introduction.
Page 107 and 108:
FIND COURSES AND ENROLL ON OUR NEW
show all

SPRING - UCSC Extension Silicon Valley

You also want an ePaper? Increase the reach of your titles

Delete template?

Save as template?