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Bethesda North Marriott Hotel and Conference Center

Feb 08, 2016 12:00 PM - Feb 10, 2016 5:15 PM

5701 Marinelli Road, , North Bethesda, MD 20852 , USA

Regulatory Submissions, Information, and Document Management Forum

Discuss the end-to-end process for document management, publishing, and technical regulatory requirements in regulatory information management.

Session 7 Track 3 - Using the New DIA GMP Quality Systems and Labeling Reference Model

Session Chair(s)

Betsy  Fallen, RN

Betsy Fallen, RN


BAFallen Consulting LLC, United States

Get information on the new DIA GMP Quality Systems and Labeling Reference Models that were developed by the Documents and Records Management Community. The session topics include an overview of the reference models and an interactive walk-through of the models, key considerations and best practices for adoption, and a case study to highlight the experiences from a major pharmaceutical firm implementing the new GMP model.


Cary  Smithson, MBA

Using the New DIA GMP Quality Systems and Labeling Reference Models

Cary Smithson, MBA

Leapahead Solutions, Inc., United States

Managing Partner

Mary  Emanoil, MS

Piloting the DIA GMP Quality Systems Reference Model

Mary Emanoil, MS

Pfizer Inc, United States

Head, TMF & Registry Operations

Karin  Schneider, MLIS, MS

Labeling Reference Model: What’s New and How to Implement

Karin Schneider, MLIS, MS

Johnson & Johnson Innovative Medicines, United States

Associate Director

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