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Bio/Medical Technology Club of Houston Meeting Announcement

Meeting Topic:
“Conducting GCP-Compliant Clinical Trials:  An Auditor’s Perspective”

Speaker:
Dalal Murgai
Regulatory Outsource Consulting, Inc.


Dalal Murgai is the founder and President of Regulatory Outsource Consulting, Inc. (ROC), a firm providing consulting services in the areas of regulatory affairs and quality assurance.to pharmaceutical, biotechnology and medical device companies.

Ms. Murgai has more than 17 years in the biotechnology/medical research industry, with GLP, GMP and GCP operations experience in all phases of pre-market development of biological and pharmaceutical drugs.  Her areas of expertise are GLP, GMP and GCP compliance audits, GXP training, preparation and evaluation of standard operating procedures and technical documents for preclinical and clinical studies as well as drug and biologics manufacturing records (including master production records, stability protocols and other documents); preparation of regulatory submissions (including INDs, NDAs/CTDs, DMFs/BMFs) for both U.S. and international regulatory authorities; and managing interactions with FDA and other international regulatory bodies.

Prior to starting a consulting business, Ms. Murgai worked for several biotechnology start-up companies including GeneMedicine, Inc., Aronex Pharmaceuticals, and Agennix Incorporated.  Mrs. Murgai obtained a bachelor’s degree from Texas A&M University, is a member of DIA, RAPs and SQA, currently serves on the DIA GCP SIAC and Industry Advisory Counsel for the Texas A&M University Professional Program in Biotechnology and also previously served on the BMTC Steering Committee.

www.regoutsource.com

Date/Time:
Tuesday, August 7, 2007
7:00 am - 8:30 am

New Location:
Trevisio Restaurant (Water Wall Building in the Texas Medical Center)
6th Floor
6550 Bertner Ave (Off Holcombe Blvd, East of Fannin)
Houston, TX 77030
(713) 749-0400

Map: www.bmtchouston.org/meetings/location.asp

Pricing: Includes Breakfast Hospitality and Parking
$15 – All attendees cash or check at the door; exact change is appreciated.

Reservations:
No pre-registration available for this event.  Registration is at the door the day of the event.

PreRegistration Closed

Payments by cash or check prior to the event are to be mailed to:
BMTC
P.O. Box 66488
Houston, TX 77266-6488

January 2006 forward, pre-registration payments by credit card are non-refundable with no-shows billed.

Day of Event Registration:
On site registrations are welcome the day of the event. Payment on site is by
cash or check only. Correct change is appreciated.

Thank you and we look forward to seeing you at this event.

Bio/Medical Technology Club of Houston
www.bmtchouston.org

 

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