Getting Your New Package & Raw Materials Qualified Thursday, March 13, 2008 Waldorf-Astoria Hotel, New York 9:30 am to 12:00 pm,  Duke of Windsor Suite
Registration for this program is now closed.  Walk-in attendees are welcome the day of the program. This program is open to DCAT Member Companies only.
The cancellation deadline for this program was Monday, March 3rd at 12:00pm EST.  In order to receive a full refund, you must have submitted your cancellation request prior to that date.

As new chemical/biological entities become increasingly complex and sensitive to environmental factors, it is essential that your packaging protect the identity, strength, quality, purity and potency of your product. To make the correct packaging selections, it is essential to have a clear understanding of the regulatory requirements governing packaging materials and testing. This presentation will address the various aspects of qualifying both primary and secondary packaging. A specific focus will be placed on the regulatory requirements of primary packaging.

This program was developed by the DCAT Packaging Council.

Program Fees: This program is open to DCAT Member Company representatives only for $39.00.

About the Speaker:
Deborah M. Thomas is the Sr. Director of Regulatory Affairs, Americas Region for West Pharmaceutical Services, Inc.  Debbie joined the company in January 2005 and is the primary contact with the United States Food and Drug Administration (FDA) for both domestic and international regulatory matters. Debbie represents West’s regulatory interests with industry associations and the FDA. She leads the North American Regulatory team in support of customers using West products. 

Debbie takes on major initiatives such as providing regulatory opinions and recommendations to customers.  She is also responsible for West regulatory submissions including, 510(k)’s and Drug Master Files.  In addition to domestic regulatory affairs activities, Debbie directs the regulatory organization as it supports global programs such as the Westar RS and RU processes and other new development programs as needed.

Debbie is a graduate of Temple University where she earned a BA in Criminal Justice. She earned her MA in Government/Political Science with the FDA as a specific area of concentration.