Label and Package Survey (FLAPS)

Description of the Project:

Icetech provided and deliver business, IT technical support and scientific research on the Nationwide Food UPC labeling codes and developed an enterprise web application and Oracle database solution for the FLAPS program that provides the most comprehensive overview of label information research on all food products in the U.S.

Scope: Specifically, the FLAPS database will enable the Food and Drug Administration (FDA) to: (1) keep abreast of market responses to food labeling rules via changes in food package labels (e.g., trans fat labeling); (2) provided a sampling frame for studies that compare analytical nutrient values with the label values; (3) examine the types of ingredients that manufacturers are using; (4) review the serving size declarations on packaged foods; (5) determine the nutrient content claims and health claims that are being used on labels and the types of products that qualify for the claims; and (6) determine prevalence of food safety (e.g., refrigeration and pasteurization labeling) and other consumer information on food products.

The FLAPS database will be able to use barcode technology and will have features with direct scanning functions.  The database and site will be Section 508 Compliant.

1.         Icetech designed a data entry form with the given fields. The form will be filled manually by the data entry operator for each product.
2.         The product label will be scanned and stored in two images, one with a lower resolutions and the 2nd at the higher resolution as required, this will increase loading speed in the database.
3.         The database will have web-based asset tracking solution that is designed to collect real-time data from devices like RFID readers, RTLS devices, barcode scanners
4.         Icetech created a master tables for storing the information for different categories and sub-categories, department, cost, location acquired, brand name, package type, size, color, flavor etc. This information is related to product bar code and details will be displayed in product detail page and admin.
5.         Product Search: Example Search by brand names, or location, cost, etc.
6.         Web access with secure login

7.         Product Admin Management
8.         Product import from and export to CSV. Which can be added to any Excel or Access format
9.         Icetech created an access Domain name (www.flapsci.com)
10.       Icetech is Hosting Website database

External Assessment of the CDER Quality Management System for the CMC Review Process

Description of the Project: Development of Office of Biotechnology Products Internal Quality Procedures (IQPs) for the FDA Chemistry

Description of the Project: Development of Office of Biotechnology Products Internal Quality Procedures (IQPs) for the FDA Chemistry

Icetech The overall project purpose is to implement and deploy the CDER Chemistry, Manufacturing, and Controls Quality Management System (CMC QMS), program specific internal quality procedures (IQPs) as recommended by the senior management team in OBP.  This work covers all aspects of the CMC Review Process as defined by the Quality Management Plan (QMP), the program specific Quality Implementation Plan (QIP), and OPS Internal Quality Procedures.  This includes activities by the contractor to coordinate, develop and implement program-level Internal Quality Procedures (IQPs) for OBP.  The delivered contractor services shall contribute directly to how OBP and OPS meet quality system requirements as defined by the QMP in the following areas:
•           Meet the basic elements of a quality management system (i.e., Plan, Do, Check, Act)
•           Improve efficiency by developing and maintaining internal resource materials
•           Promote and ensure consistency of internal processes and practices
•           Provide greater access to critical review related procedures
•           Optimize performance practices, capabilities, and results within the organization
•           Capture and disseminate organizational knowledge
•           Facilitate communication across the organizations and with stakeholders
•           Share best practices for review and scientific information to enhance work products
•           Serve as a mechanism for understanding and managing performance expectations
•           Document existing sources of internal guidance and other tools and metrics serve as the basis for performance metrics (including internal audits and self-assessments)
•           Defines quality-related needs for the CMC review process
•           Documents organizational approaches and compiles available tools in an organization-specific internal quality procedure (IQP) that aligns with the CMC QMS