Category: Essay

I have found a biologic approved in 2012, called Bivigam. It is an infusion of immune globulin (human). Please see below the following links, they have all the information regarding the biologic.

• Identify the product by both Trade and Brand name as well as the product’s sponsor
• Describe the reason for your Group’s interest in the product
• Identify dates of critical regulatory milestones for the product (including BLA
approval date)
• Provide a detailed description of the product (as available from public sources),
including its molecular mechanism(s) of action and specific indications for use
• Identify the class/type of product and explain why the product is regulated by
CBER© 2014-2015 Northeastern University: College of Professional Studies 5
• Identify the general and product-specific FDA guidance documents that apply to the product and the premarket submission, as applicable
• Describe what preclinical safety data was likely submitted to CBER in support of
the sponsor’s IND and BLA applications
• Describe what the Sponsor’s IND clinical and investigational plan likely contained

In the United States, there is no real standard when it comes to sentencing and punishment which is why the criminal courts are always under a lot of scrutiny. There are five main goals/ theories behind criminal sentencing: retribution (aka punishment), deterrence, incapacitation, rehabilitation, and restoration. In the United States, we believe punishment is necessary to maintain order and show fairness to those who do not violate the rules and laws we live by. “Punishment is used on many different levels, we use it from the basics to teach children right from wrong, and we use it as a means to deal with societies most despicable offenders.” Today there are many things the criminal justice system aims to do by imposing punishments and sentences.

Write a five page argumentative paper on the criminal court processes and the issues of criminal sentencing in the State of California. Be sure to include legal vocabulary and provide examples.

Much has been written about the disease, Alzheimer’s, and it IS Disease, not normal aging. Find an article or video on some aspect of Alzheimer’s disease and summarize it. please post the article or video site.

Final Assessment Case Study

Objective of this assignment:

This activity serves as a final assessment for the course. It provides you the opportunity to demonstrate how well you have achieved the learning outcomes of the course. You are to provide your knowledge of the strategic and administrative function of Human Resources by thinking about the situation of Southwest Airlines recent merger and their expansion.

Deliverable:

Read and reflect on the case study below and prepare a response paper of not less than five pages (excluding title and reference pages) with appropriate in text citations. Demonstrate your research and analytical skills in developing your comprehensive paper by using the organizations website and outside articles written about the organization to supplement the information provided in the case study. However, the case study is unique in that it is focused on the HR ramifications and most of the outside reports you will locate articulate the business side of the merger or expansion possibilities. Tailor your paper to the HR ramifications of the merger and expansion.

Keep in mind that the purpose of this final assessment is for you to demonstrate your knowledge of the strategic and administrative function of Human Resources. While the business side of the situation is the foundation, it is the command of the needed tasks and role for the Human Resource function that you are to focus most of your attention.

Key Components

The key components of the paper are as follows:

1. Title page

2. Introduction in which you restate the issue(s) and state the purpose of the paper

3. SWOT analysis from the HR perspective

4. Recommendations to address the issues. Scholarly research is expected to support the recommendations.

Examples of issues that may want to be elaborated upon may be possible redundant positions, maintaining the culture of both organizations (or not), combining compensation and benefits plans and union involvement (just to name some).

5. There are many tasks for recruiting and hiring for the expansion (in various global locations). Think about and list what those tasks are.

6. Provide the metrics for evaluating the outcomes of the expansion of the organization (again, from an HR perspective).

7. Synthesize and summarize your thoughts about the merger and expansion (from an HR perspective), including recommendations for aligning the HR function of the two organizations and addressing any of the S.W.O.T. assessment HR related elements as appropriate.

6. Reference page containing at least five scholarly references cited in the paper and presented in APA guideline format

Situation:

Southwest Airlines is a major airline in the United States with limited flights outside the country. The organization has a strong culture which is described in the following excerpt from Gary Kelly, CEO Southwest Airlines found on the Southwest Airlines Website. https://www.southwest.com/html/about-southwest/index.html?int=GFOOTER-ABOUT-ABOUT

Living the Southwest Way

(Gary Kelly states that)…..I ask three things of the 46,000 Southwest Airlines and AirTran Airways Employees every day: Work hard, have fun, and treat everyone with respect. We call this Living the Southwest Way, and it comprises three characteristics that we look for in job candidates and require of our Employees: a Warrior Spirit, a Servant�s Heart, and a Fun-LUVing Attitude. While it may sound simple (and it is), the impact can be profound. Our Culture has long been admired and has earned Southwest much recognition, including a yearly spot on Fortune�s �World�s Most Admired Companies� list (we ranked seventh this year) and the distinction of being named one of the Best Places to Work in Glassdoor.com�s 2013 Employees� Choice Awards. Our Culture is not a program or a campaign; it is the sum of the personalities and behaviors of our People who Live the Southwest Way every day.

(The following is fiction but is the situation to consider for this assignment). Due to the recent acquisition of AirTran Airways and with the possibility of acquiring other airlines that will expand the organization to other countries, Southwest Airlines will add thousands of employees quickly from any number of existing airlines in a variety of global locations.

Faced with the tasks of maintaining the values of the organization, consider and propose steps the Human Resources team will need to take to achieve a successful merger of the two companies and to expand to additional global locations.

PLEASE NOTE: Much has been written about Southwest Airlines, its culture and the recent merger. While that information may be used as reference material, the situation you have been asked to use for your application of your knowledge about HR is unique. Do not merely cut and paste from what you find in the documents you locate.
NOTE
Please in proper APA format with abstract.

Your culminating assignment will help you and a colleague reinforce what has been learned throughout our time together by experiencing and reviewing your practical application of the theory and processes that affect organizational change.

Phase I: Select ONE of the following options
You will demonstrate organizational change and leadership in a detailed action plan by selecting one of the following options

Option I: Rejuvenate an existing but flawed or stalled change process
Select a conflict situation at your school or district or work site that originated as a result of the introduction of a new change initiative but has stalled or created disequilibrium and now requires resolution.

First, identify the change that has snagged and caused issues
Provide a brief background or history of the issue including such item as
Whose idea was it?
Was it a consensus or forced initiative?
Who �bought in� and who didn�t?
Clarify the situation and determine the true roadblocks by identifying such items as the driving forces, restraining forces, personal agendas, specific interest groups or cliques, varying agendas of the major players, etc.). You decide. You may also want to consider some of the following
Environmental forces (national, regional, state or community level forces driving change at your school)
Strategic Imperatives (Action your school or district needs to take)
Organizational Imperatives (what needs to change in the school or district?)
Cultural Imperatives (what school or district norms need to change)
Leader & Employee Behavior (what specific behaviors might need to change?)
Mindset � What assumptions, beliefs, and mental models need changing?)
Next, go to the �balcony� like David King at Kennedy High to gain insight. What do you see? What frames are paramount and which are lacking?
Now you are ready to create a strategy based on your growing knowledge of organizational change and leadership to remedy the stalemate or disequilibrium that includes a minimum of
5 � 6 action steps based on your knowledge of theory and framing
Address such items as what will your role be? Who will be involved?
From which frames and organizational theorists will you borrow the heaviest?
Consider Kotter�s 8 steps for leaders outlined in Learning Activity 8: how might this help?
Lastly, what intimidates you the most about becoming an agent of change and enacting this plan?
Option II: New Territory � Identify an area either in your classroom, school district or place of work you consider needful of change by asking �What type of change is required in your workplace, classroom, your school or district?�

Using that as a focus, develop an action plan for instituting your selected change initiative based on those skills and information gained during the first four weeks of class. Your task is to serve as change agent to design � and hopefully implement � a personal change initiative. In this process you should

Describe the change you want to implement and provide a brief rationale
What do you immediately see as the three key benefits of this change?
Identify key restraining forces and driving forces
Clarify the situation and determine the roadblocks by identifying such items as the driving forces, restraining forces, personal agendas, specific interest groups or cliques, varying agendas of the major players, etc.). You decide. You may also want to consider at least some of the following
Environmental forces (national, regional, state or community level forces driving change at your school)
Strategic Imperatives (Action your school or district needs to take)
Organizational Imperatives (what needs to change in the school or district?)
Cultural Imperatives (what school or district norms need to change)
Leader & Employee Behavior (what specific behaviors might need to change?)
Mindset � What assumptions, beliefs, and mental models need changing?)
Consider how you can provide �ownership� early in the change process to prevent alienation and bring everyone aboard
Now you are ready to create a strategy based on your growing knowledge of organizational change and leadership to remedy the stalemate or disequilibrium that includes a minimum of
5 � 6 action steps based on your knowledge of theory and framing
Address such items as what will your role be? Who will be involved?
From which frames and organizational theorists will you borrow the heaviest?
Consider Kotter�s 8 steps for leaders outlined in Learning Activity 8: how might this help?
Explain the reasons for your particular approach (be bold and honest, indicating where you are not certain)
How will you measure the success of your change?
Lastly, what intimidates you the most about becoming an agent of change and enacting this plan?
Final assignment parameters:

The use of graphics (pictures, charts, graphs, videos, PowerPoint, etc.) is encouraged
Outlines and bullets may be acceptable for certain elements of your change strategy (you decide which)
Reference in your plan a minimum of two sources other than your text, and a minimum of two organizational theorists
Make certain to address the requirements listed in your option selection
Final Assignment Suggestions
Be bold with this assignment and don�t view it as simply a �head exercise.� Instead, be hopeful of eventual implementation always remembering what Einstein said: �Great spirits have always encountered violent opposition from mediocre minds.�

1. Choose one of the cases found on this website https://forum.prisonplanet.com/index.php?topic=199977.0 that you were not familiar with.
2. What did you find most shocking about this case? Identify the vulnerable population in this case. (You must use two sources of information on you chosen case (one may be the one associated with the case, if it has one and you must find another credible source which discusses the case. You may NOT use the wikipedia but should use a credible source (internet or other). Please include your citation and reference at the end of your discussion).
3. Look at the following weblink https://www.cioms.ch/publications/layout_guide2002.pdf (Links to an external site.) where you will find the International Ethical
Guidelines for Biomedical Research Involving Human Subjects. Choose two of those guidelines that you think might have been breached in the case you have chosen and briefly explain how they were breached according to your understanding of the guideline (include the number of the guideline in your answer).