JUNE 24th 2005

This introductory course on medical and clinical terminology is an eye opener to people who have had an engineering or non-medical academic background. This course introduces you to medical terminology and helps you understand how and why specific word parts are selected to form the thousands of medical and English terms that you will use daily in your career.

Instructor: Dr. Sudhi Gautam

This is one of several courses sponsored by the Silicon Valley Section to assist people transitioning into the biomedical industry. To get a complete list of courses sponsored, or to register for a class, contact Jim Bischof jbischof01@aol.com. (408-972-8852)

Course #614: Quality Management System Implementation Tools and Techniques
This course is a follow-on for the ISO 9001:2000 (#604) and/or ISO 13485:2003 (#618) courses or can be taken by anyone interested in understanding and practicing implementation methods for a quality management system. It is valuable for quality managers and practitioners who are implementing a QMS in their organization.
Course objectives are to provide participants with
Familiarity with best practices· for QMS implementation
Experience in developing implementation plans using· exercises in the methods and case studies from their own or other organizations.
Course Content:
This is a practical overview that explores best practices for QMS implementation in the high technology and biomedical fields. The course covers:
Importance of a systematic approach for QMS· implementation: what it is, what it means, and how it provides value
· Factors to consider when planning a QMS implementation: organizational environment, human elements, business objectives, and costs
Role of· important quality and productivity methods such as Six Sigma, Lean, Baldridge, Balanced Scorecard in a QMS
Practice with tools that can assist and improve· QMS implementation
Developing metrics to assess implementation success:· what, why and how
Evaluating best practices for your organization: how to· determine what is "best" for your company
Instructor: Marieann· Shovlin (m.shovlin@comcast.net) Cost: $175/$80 (Lower price is for unemployed persons)

Course #603: Survey Course 510k's (Pre-market Notification) & PMAs (Pre-market Approval)
This course will cover material that is essential for those individuals who submit 510k and PMA applications for medical devices to the FDA. This course will detail when these submissions are required, the information required in each submission, and the FDA review process involved. Handouts will be provided.
Instructor: Mike Crompton Cost: $75/$30 (mcrompton@spinalkinetics.com) (Lower price is for unemployed persons)

Course #602: Quality System Regulation for Medical Devices.
This is the basic FDA regulation for medical device companies. Here are the objectives for our two-Saturday sessions:
By the end of the two-day seminar, you will be able to:
1. Identify general compliance expectations of the FDA and State of California for medical device manufacturers
2. Identify the differences between ISO 9001:1994, ISO 13485:2003 and the FDA Quality System Regulation
3. Identify the key points of the QS Regulation
4. Complete an initial "gap analysis" of what's new/different in a QS Regulated industry
5. Understand FDA audit process, including QSIT, QSR "satellites" and Part 11 compliance issues.
You will be able to talk to prospective interviewers using FDA compliance vocabulary and concepts. While you will not be an expert in FDA compliance, you will be able to identify your personal FDA QS strengths and weaknesses based on your experience in a non-regulated industry. We think this class will help you showcase your career experience in a non-regulated industry. We hope you will be able to demonstrate in an interview situation that you could transition easily to the medical device industry.
Instructors: Bill Hufford (w.hufford@comcast.net) Cost: $270/$110 (Lower prices is for unemployed persons.)

There are only a limited number of positions open for these classes. If you or any of your colleagues are interested in these classes, please register with Sylvester Muthini (siliconvalleyregistrar@yahoo.com) as described below.
Payment to be made when you show up for the class. Please bring a check or your credit card. We accept VISA, Master Card, and American Express only.

Registration Instructions
To register for these courses, e-mail your contact information including full name, company, home address, company address, e-mail address, and phone numbers (home, cell, and work) to the registrar, Sylvester Muthini, at siliconvalleyregistrar@yahoo.com.
He will provide you with confirmation that you are registered.
For any general questions contact Jim Bischof 408-972-8852. Jbischof01@aol.com For questions about course content, contact the instructor, whose contact information is above.
Please register as soon as possible so the instructor can prepare the proper number of handouts.

If there are any classes in our curriculum that you would like to hold at your plant site, please contact me, and I will see if that can be arranged. To a company hosting a class, we offer one free student, and a 20% discount for other students from the host company.
If three or more students from the same company attend the class (not from the host company), we offer a 10% discount to those students.
If there is a course you would like to see added to the curriculum, or you would like to teach a course, please contact me, and I will see if that can be arranged.
As noted above.