Hi all,
Anybody have a recommendation for a consultant to come in-house to provide ISO 14971 training for a ~230 person capital medical device company? We are located in Sunnyvale, CA.

Thanks,
Eric

Try these guys.....

http://www.compliance-alliance.com/ISO14971.htm

Try these guys.....

http://www.compliance-alliance.com/ISO14971.htm:agree1: Based on a presentation By Dan Olivier, that I attended, I think he would be a good candidate. You could attend the seminar, gain some knowledge and get a first hand impression.

Hi,
Thanks for the feedback, looks like they do seminars (which I'll line myself up to attend). Would mainly like to get somebody to come in-house to give training to a larger group.

Thanks,
Eric

Hi,
Thanks for the feedback, looks like they do seminars (which I'll line myself up to attend). Would mainly like to get somebody to come in-house to give training to a larger group.

Thanks,
EricDan Olivier consults. Speak to him at the seminar. His company is Certified Software Solutions. (http://www.certifiedsoftware.com/services/services.htm)

Dan Olivier consults. Speak to him at the seminar. His company is Certified Software Solutions. (http://www.certifiedsoftware.com/services/services.htm)
Dan is a good choice, you can also look into Tim Stein (Business Performance Associates).

Barry Craner is a good instructor. He chairs ASQ Silicon Valley's biomedical section.

Hi,
Thanks for all the replies, I will get in touch with the folks you recommend.

Thanks,
Eric

Here's the email Jim just sent out this week:

----- Forwarded by Josephine Tai/MLS/MS/PHILIPS on 2006-02-16 10:15 AM -----





e-mail adresss removed
2006-02-16 06:39 AM
To
"undisclosed-recipients:"@ e mail adresss removed
cc

Subject
#1 ASQ Biomedical Classes
Classification





To: Members of the ASQ Quality Advisory Board
From: Jim Bischof
Class Coordinator Phone: 408-972-8852
Cell: 408-806-5139
e-mail: e mail address removed
Date: February 16, 2006
Subj: Next two Upcoming ASQ Biomedical Classes

Dear Members of the Quality Advisory Board: (14 to 550)

Below is an announcement of the next 2 upcoming biomedical classes sponsored by
the Silicon Valley Section of ASQ.


Title: Risk Management #611
Dates: March 9, 16, 2006
Cost: $175.00 ($80.00 for unemployed persons)
Time: 6pm to 10 pm
Instructor: Barry Craner
Location: Will be provided later to registered students.


Title: Lean Manufacturing #608
Dates: March 13, 2006
Cost: $175.00 ($80.00 for unemployed persons)
Time: 8am to 12pm, 1pm to 5pm
Instructor: Paul Jahanian
Location: Will be provided later to registered students.


(Detailed class descriptions are below)

There are only a limited number of positions open for these classes. If you or
any of your colleagues are interested in any of 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.
There is no on-line registration for these classes.

Registration Instructions
To register for this course, 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
e mail address removed.

He will provide you with confirmation that you are registered, or notify you
that you have been placed on a waiting list.

For any general questions contact Jim Bischof 408-972-8852.
(mail to:e mail address removed) For questions about
course content,
contact the instructor, whose contact information is below.
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, YOU ARE ENCOURAGED TO REGISTER EARLY FOR THESE CLASSES. SOME
CLASSES ARE CANCELED BECAUSE OF LOW EARLY ENROLLMENT, AND OTHER CLASSES ARE

OVER SUBSCRIBED, SO SOME STUDENTS HAVE TO BE TURNED AWAY.

Course #611: Risk Management
· This course will provide a work-shop setting in which the major risk-identification and risk-reducing methods will be characterized
o Failure Modes and Effects Analysis – FMEA,
o Fault Tree Analysis – FTA,
o Hazard and Critical Control Point Analysis – HACCP
· Analysis will be performed real-time in class in order to experience practical implementation of these processes.
· Examples will be worked on in class
o Identifying product and process hazards,
o Evaluating the hazards for possible level of risk,
o Ways to creatively brainstorm on reducing (mitigating) the risk.
· The course will also review recently enacted standards relevant to medical device risk management.
· Applicability of these analytical processes to the product development cycle will be explained
o The transfer to production
o Production phases,
o Examples of the use of such tools, many from the instructor’s work experience, will be explained and used in class
§ Identifying and minimizing risk impact during production
§ Critical process point identification / mitigation
· How to adapt many of these skills and processes for your specific needs,
o In or out of the medical device development and manufacturing environments.
· Examples also provided: Determining risk-level, Assignment of risk-impact, How to implement both predictive and preventive processes.
· Summary and introduction of the issues facing the FDA and Europe early on, which moved them toward the focus of requiring risk management in all aspects of product development and manufacturing, including mechanical, electrical, software, and disposable products.
· Full, usable procedures on Risk Management, Fault Tree Analysis, and Failure Modes and Effects Analysis
· CD with ~60 public and original resources for Risk Management in medical devices
· Binder with >100 pages of material, including all class presentation notes, procedures, worksheets, etc.
Instructor: Barry Craner (e mail address removed)


. Course #608: Overview of Lean Manufacturing for Low-volume/High-variety Production Environments
This course will provide overall strategies for implementing Lean Manufacturing in low-volume/high-variety production environments to dramatically reduce lead-time, inventory, defects, space, overhead, and non-value-added functions.

The course will include:
- overview of the principles of Lean Manufacturing
- implementing Lean Manufacturing in low-volume/high-variety production environments
- implementing Lean philosophy in non-manufacturing environments
Instructor: Paul Jahanian (e mail address removed)

Rose,
Thanks for all the great info. We prefer not to include e-mail adressess in posts. I left the phone numbers in place - do you have a link to a web site for this AQS Section.

Their web site is not always up to date. They have been sending out email communications on upcoming meetings and classes. You'll need to contact Jim Bischof to discuss group discount rate. Also, if you host the class at your company site, there is a discount too. For class details, you'll need to contact the instructor. Barry's class materials and workshop exercises are excellent. And, he goes over the risk analysis tools in the workshop exercises too. Best of all, you got a CD ROM. Good rate for amount of materials learned and received.

We remove the e-mails so spider bots don't pick them up.

Please contact rose24m03 through a PM to get the e-mail information.

We remove the e-mails so spider bots don't pick them up.

Please contact rose24m03 through a PM to get the e-mail information.The link is still in the post as "e-mail". I think it will be safe this way.

Since Phone # was not removed, please contact ASQ directly. Thanks.