Digital Commons Network^™

Fda’S Quality Systems Methodology At Pharmaceutical Manufacturing Sites, Warren Adis

Communications of the IIMA

This research details the FDA's quality systems methodology used in its inspection of biopharmaceutical manufacturers in the time period between 2003 and 2009. It analyzes the violations specified in FDA site inspection warning letters, reviewing their frequency and specificity. This analysis is an exploration into FDA activity in this sector, focusing particularly on finished pharmaceuticals, and serves as an initial evaluation of the FDA’s performance. In addition, the study pays particular attention to whether the FDA’s risk methodology has enhanced the overall inspection process and increased its quality assurance.

The Fbi Virtual Case File: A Case Study , Jack T. Marchewka

Communications of the IIMA

The Federal Bureau of Investigation (FBI) began developing a case management software system called the Virtual Case File in 2000, but eventually abandoned the project in April 2005. The cost of this project was estimated to be over $170 million, and this waste of tax payer money drew sharp criticism. The impetus for the project was due to the FBI’s aging technology infrastructure that included 386-based personal computers and a 12-year-old network system. In 2000, Congress allocated almost $340 million for the proposed FBI Information Technology Upgrade Project (FITUP) that was soon divided into three parts and renamed Trilogy. This …

Methamphetamines, The Crystal Method And The War On Drugs, Bernard J. Hughes

ExpressO

Illegal methamphetamines and their clandestine production is a growing threat to the nation and the war on drugs. States such as Missouri, Oregon, Washington, Iowa, Ohio and Kansas have been devastated by the the drug. Is this a problem that the criminalized drug war can effectively deal with? Was the meth epidemic a direct result of the war on drugs? The current war on drugs will be challenged by meth as well as by the abuse of pharmaceuticals, can it remain tenable? Should we continue to keep drugs such as cocaine and marijuana illegal or should we consider legalization? The …

Emu Today, June 17, 2014, Eastern Michigan University

EMU Today

No abstract provided.

America's Missing Link: Educational Reform And Workforce Development, Sharon A. Weiner, Lana W. Jackman, Glen Warren

Libraries Faculty and Staff Presentations

This presentation was given at a White House meeting about the potential role of information literacy in Michelle Obama's Reach Higher initiative on June 18, 2014.

The Collapse Of Sensemaking At The Pennsylvania State University, Travis Schott

Communication & Leadership Dissertations and Theses

The Pennsylvania State University (PSU) has generated billions of dollars from collegiate licensing of products and corporate sponsorship due largely to the success of their football program. Therefore, significant economic consequences exist if the PSU brand sustains damage to its image and reputation. This thesis examines events and communication among key actors at PSU who had knowledge of allegations, or who were directly involved with the investigation of Jerry Sandusky, the former PSU football defensive coordinator, for improper sexual contact with minors dating back as far as 1998. Two reports published following independent investigations of this incident provide detailed accounts …

The Eastern Echo, June 17, 2014, Eastern Michigan University

EMU Student Newspaper: The Normal News & The Eastern Echo

No abstract provided.

Chhs News, College Of Health And Human Sciences, Georgia Southern University

College of Health Professions: News & Publications (2012-2023)

No abstract provided.

Where There's Smoke, There's Fire?: The Cloud Of Suspicion Surrounding Former Offenders And The Eeoc's New Enforcement Guidance On Criminal Records Under Title Vii, Tiffany Nichols

Georgia State University Law Review

No abstract provided.

Emu Today, June 16, 2014, Eastern Michigan University

EMU Today

No abstract provided.

The Setonian, June 13, 2014, Seton Hall University

2014

No abstract provided.

Preserving The Quality Of Architectural Tactics In Source Code, Mehdi Mirakhorli

College of Computing and Digital Media Dissertations

In any complex software system, strong interdependencies exist between requirements and software architecture. Requirements drive architectural choices while also being constrained by the existing architecture and by what is economically feasible. This makes it advisable to concurrently specify the requirements, to devise and compare alternative architectural design solutions, and ultimately to make a series of design decisions in order to satisfy each of the quality concerns.

Unfortunately, anecdotal evidence has shown that architectural knowledge tends to be tacit in nature, stored in the heads of people, and lost over time. Therefore, developers often lack comprehensive knowledge of underlying architectural design …

Emu Today, June 13, 2014, Eastern Michigan University

EMU Today

No abstract provided.

Emu Today, June 12, 2014, Eastern Michigan University

EMU Today

No abstract provided.

Vex Robotics, Ho Joon Cha, Joshua Del Real, Jamie Kalb, Thomas Nance, Jenny Yang

Mechanical Engineering Senior Theses

The objective of our project was to design and construct a control system for communication between two autonomous robots, of different size and capabilities, in an environment with numerous obstacles and challenges. These challenges, completed autonomously, involved moving over and under barriers along with the obtainment and transportation of spherical objects. Our project was tied to the VEX Robotics competition environment as we tested our robots by competing at the World Championships. Unfortunately, due to time and budget considerations, we had to scale back our sensor subsystem. This led to a simpler control system than originally intended; however, we were …

Leveraging A Cross-Functional Team For Critical Professional Development: The Work After The Leading For Change 2013 Conference, Darcy Orellana, Paula Pitcher, Phil Sisson, Peter Shea

Leading for Change

There’s no single way for a campus to “act” after sending a team to the Leading for Change: Diversity Practices in Higher Education 2013 conference. At Middlesex Community College we leveraged the expertise and perspectives of our cross-functional and cognitively diverse team to establish a Closing the Achievement Gap working group to promote organizational learning about the topic. Learn how this collaborative group is telling the MCC data story and providing opportunities for the entire campus to learn, discuss and share knowledge about promoting success through inclusive practices at a college-wide professional day dedicated to closing the achievement gap.

State V. Ellis Respondent's Brief Dckt. 40898

Not Reported

No abstract provided.

State V. Williston Clerk's Record Dckt. 42115

Idaho Supreme Court Records & Briefs, All

No abstract provided.

Volume 51, Number 43: June 11, 2014, University Of North Dakota

University Letter Archive

No abstract provided.

Emu Today, June 11, 2014, Eastern Michigan University

EMU Today

No abstract provided.

Aesthetic Considerations In The Law, Rose L. Lipman

St. John's Law Review

No abstract provided.

Emu Today, June 10, 2014, Eastern Michigan University

EMU Today

No abstract provided.

Chhs News, College Of Health And Human Sciences, Georgia Southern University

College of Health Professions: News & Publications (2012-2023)

No abstract provided.

Lausti And Salazar: Are Religious Symbols Legitimate In The Public Square?, Katie A. Croghan

Georgia Journal of International & Comparative Law

No abstract provided.

The Role And Mission Of The United States Food And Drug Administration: Regulator, Watchdog, Facilitator, Or "All Of The Above", Roseann Termini J.D., Anthony Knabb Didonato J.D.

North Carolina Central University Science & Intellectual Property Law Review

No abstract provided.

Commodification Of The Female Egg: Stem Cell Technology And The Future, Rachel Ostander

North Carolina Central University Science & Intellectual Property Law Review

No abstract provided.

Emu Today, June 9, 2014, Eastern Michigan University

EMU Today

No abstract provided.

Compensating Victims Of Crime, Douglas N. Evans

Publications and Research

Victims of violent crime are often unable to access financial compensation to offset the costs of victimization (e.g., medical, lost wages, funeral expenses) despite the massive amounts of money set aside for just that purpose. Currently, there is about $11 billion in the federal Crime Victims Fund (CVF). Less than 10 percent of this amount is allocated to state victim compensation programs. This report explores the funding mechanisms used by federal and state governments to compensate victims of crime, and it describes the administrative and policy problems in these systems. The report offers several recommendations for improvement. States have their …

Can Citizens Better Use The Ballot Initiative To Protect Wildlife?: The Case Of The Mountain Lion In The West, Tyler Welch

Colorado Environmental Law Journal

No abstract provided.

Doe V. Wilmington Housing Authority

2014 Decisions

USDC for the District of Delaware