Hey Tim Noonan

Food and Drug Administration (FDA)

During the day I focus on issues involving information and in my free time I turn my attention to the community. With over thirty years of experience, I have seen it all from Y2K to AI. Checkout my Professional Experience page. In my free time I founded the 19th Ward Mutual Aid group. Providing support to the 19th Ward and beyond. Checkout my Volunteer Work page. Thanks for visiting.

CLIENT PROFILE

Over the last quarter century major shifts in records storage, multimedia management, disclosure requirements, electronic product submission, scientific computing and federally mandated records keeping requirements make it necessary for FDA to move from a paper centric agency to a media neutral information-based organization.

CLIENT REQUEST

The FDA is responsible for protecting the public health by assuring the safety, efficacy, and security of human and veterinary drugs, biological products, medical devices, tobacco products, our nation’s food supply, cosmetics and products that emit radiation

I developed a Governance, Risk & Compliance (GRC) solution to U.S Food & Drug Administration (FDA) as they move to a broader information-based organization by supporting core functions related to the following:

  • On-site Records Material Processing and Operations Support
  • Records Management
  • Relocation Services
  • Electronic Discovery

Federal regulations mandate the support of the following regulations: Federal Food, Drug and Cosmetic Act , Food and Drug Administration Safety and Innovation Act (FDASIA), and the following supplementary statutes: Prescription Drug User Fee Act (PDUFA), Generic Drug User Fee Act (GDUFA), Medical Device User Fee Act (MDUFA), Biosimilar User Fee Act (BsUFA), Animal Drug User Fee Act (ADUFA), Animal Generic Drug User Fee Act (AGDUFA), Mammography Quality Standards Act (MQSA), Export Reform and Enhancement Act (EREA), Freedom of Information Act (FOIA), Family Smoking Prevention and Tobacco Control Act (FSPTCA), and Food Safety Modernization Act (FSMA).

Technology

  • FedRAMP: The Federal Risk and Authorization Management Program is a United States federal government-wide compliance program that provides a standardized approach to security assessment, authorization, and continuous monitoring for cloud products and services.
  • Iron Mountain: Records Management