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Our Workshop Page Coordinator is

Don Griego

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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 October workshop went well. See details here.

Our next workshop wont be until February as follows:

TOPIC

Taught By

Date;Tm;Loc

Cost

Contact

"Warning Letters and the Law"

Kathy Rangus

February 23, 2005; 6pm; Gen-Probe

$50 Members with RSVP, $60 "Non Member / Day of the Event".

Don Griego

Abstract:

Using recent warning letters issued by the FDA, this workshop will investigate the laws cited in the letters and relate the laws to drug and device regulatory requirements. The workshop will cover the basic requirements of IND, NDA, BLA, and GCP.

Goal:

An understanding of how US statutes form the basis for regulatory requirements applicable to drugs, biologics, and devices. An understanding of the purposes and differences between IND, NDA, and BLA. An introduction to GCP requirements and to commonly used acronyms.

About Our Speaker:

Kathryn Rangus has worked in the areas of regulatory affairs and clinical research since 1976. Her responsibilities have included premarket approval applications, clinical trial management, quality assurance and control, preclinical testing, labeling and advertising compliance, and foreign applications. She has prepared IND, NDA, BLA, PMA, ANDA, IDE, 510(k), and master files.

Ms. Rangus received her bachelor's degree in Zoology from the University of California, Riverside; Master of Science in genetics and developmental biology from San Diego State University; and an MBA from National University.

She is a member of the Regulatory Affairs Professional Society and is a certified Regulatory Affairs Professional. She is also a member of the Drug Information Association, a founding member of the San Diego Regulatory Affairs Network and a past President. Since 1989, Ms. Rangus has been President of Drug & Device Regulatory Services, Inc., which provides consulting services to pharmaceutical, biologic, and medical device companies.

Kathryn Rangus

_________________________

krangus@ddrsinc.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.

*Name:
Job Title:
*Email:
*Payment Plan:	$50 Members with Reservation Check or cash at the meeting I have mailed this form with the check I will pre-pay using my credit card below shortly $60 "Non Member/Day of the Event" Check or cash at the meeting I have mailed this form with the check I will pre-pay using my credit card below shortly Cancellation It's not the day of the event so please cancel me with no penalties or reimbursement expected. It's not the day of the event, please reimburse me for money paid. It's the day of the event, please cancel me and contact me of fees.
Member #:	used for the .3 re-certification units
Phone (H):
Phone (W):
Company:
Mailing Address:
Comments such as "this RSVP is for July to save $15 off materials"
Press submit to register for our workshop. By submitting this form you are submitting your RSVP for this month's workshop unless the date for this month's workshop has passed.

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