|
|
Our Workshop Page
Coordinator is
Don Griego
Jump Below to:
|
 |
Please contact me
with any workshop related questions or comments.
Typical Workshop (4/2002)
 |
|
|
|
Workshops are held once per month
(usually 4th Wednesday) as a cost effective way to keep up to date on
quality practices, and to network with some of the best quality
professionals in industry. Dinner & 0.3 re-certification units
included. See
feedback from past workshops, "... the
workshop was AWESOME!", or "... the best investment I've made in
years". |
This Month's Workshop
Our
September workshop went well. See
details here.
Our October workshop is as follows:
|
TOPIC |
Taught By |
Date;Tm;Loc |
Cost |
Contact |
|
"Introductory
FDA & cGMP Regulations" |
Abe Wong
abeconsults@yahoo. com |
October 27,
2004; 6pm; Gen-Probe |
$50 Members with RSVP, $60 "Non Member / Day of the Event".
|
Don Griego |
Abstract
This workshop is
an introductory class focused on FDA cGMP regulations. It provides the
basic GMP information for regulated consumer products under the Food, Drug, and
Cosmetics Act.
This workshop is
for individuals interested in Quality Assurance and Regulatory Affairs
processes. It presents a bigger picture to study the anatomy of an FDA
audit as well as the critical issues of handling a recall.
About Our Presenter
Abe Wong is a Principal Consultant with
GMPSigma, LLC
Mr. Wong has been providing consulting services to multinational companies to
improve their efficiency and quality in operations for over twenty years. Mr.
Wong has a Master’s degree in Telecommunications. He received various
certifications, including RAB Certified Lead Auditor, Certified Chinese
Interpreter, and Certified Six-Sigma Black Belt. Mr. Wong is fluent in English,
Mandarin and Cantonese Chinese.
Mr. Wong has written articles and conducted seminars on topics regarding FDA
rules and cGMP regulations, as well as other product quality and safety topics
including International Product Regulations. He is also an expert on China’s CCC
import/export regulations, the exemption requirements, and China’s individual
income tax law system for foreigners.
Mr. Wong served in the U.S. Department of Defense, worked with defense and
non-defense contractors, also working with biomedical companies and other
manufacturers in establishing and facilitating their international operations.
Among the companies that Mr. Wong assisted are: Life Force International, CMTC,
Solar Turbines, Intel, HP/Compaq, IBM, Hitachi, Samsung, Fujitsu, Sony, NEC,
Quinton Cardiology, Becton Dickinson, Xerox Corporation, and Boeing.
|
_____________________________
Abe Wong is a Principal Consultant
with GMPSigma, LLC
Telephone: 858-442-0423
Email: awong@gmpsigma.com |
Dinner
will be served at 5:30 and the program will begin at 6:00 PM
Location:
Gen-Probe Inc. at 10210 Genetic Center Drive
San Diego, CA 92121. Their phone: (858) 410-8000.
See map here.
Time:
5:30 PM – 9:00 PM
If
you are interested in attending this workshop, please fill out and
submit the following on-line form and bring a check to the meeting, or you can mail this form
with the check
made out to
the PO box at the bottom of the page, or you can pay by credit card as
outlined below.
*
spaces are mandatory.
|
After submitting your RSVP by hitting the
"submit registration" button above,
return here and click on the appropriate PayPal button
below to pay now. If the class is cancelled or you submit a
cancellation within 24 hours, your money will be refunded to you in full.
 Pay Now
Using Pay Pal or Credit Card
|
|
|
Future Workshop Plans
In an effort to allow
easy printing of this month's workshop information, we've moved all future
workshop information to a separate page.
Click here for future workshop plans.
Past Workshop Archives
In an effort to allow easy printing of this month's workshop
information, we've moved all past workshop information to a separate
page. Click here for past
workshop info.
| |
|
GMP & ISO Compliance
|
Sponsored by UCSDE
Free Info
Sessions. Click here
for more info.
or call (858) 882-8018
|
Sarbanes Oxley, ISO, BS, HIPPA,etc.
|
|
Pay now
with credit card or PayPal.
 |
|
