Tag: Model Answer

  • [Solved] thomas week 5

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    – What does the research say about best practices in teaching vocabulary? – How did you learn new words while in school? – Which strategies do not work?

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    Assignment Prompt & Instructions

    – What does the research say about best practices in teaching vocabulary?
    – How did you learn new words while in school?
    – Which strategies do not work?

  • [Solved] 98

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    Executive Solution Overview

    – , create a simple diagram of one of the business processes used by ClubIT. This process can be creating a food order, a sale, or any other business process that could happen within ClubIT. – Insert your diagram into the Discussion response. Make sure the process is clearly labeled

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    Assignment Prompt & Instructions

    – , create a simple diagram of one of the business processes used by ClubIT. This process can be creating a food order, a sale, or any other business process that could happen within ClubIT.
    – Insert your diagram into the Discussion response. Make sure the process is clearly labeled

  • [Solved] Education thomas week c assignment

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    Executive Solution Overview

    **Reading and writing instruction must be grounded in research. A valuable resource for educators is the What Works Clearinghouse (WWC), a government agency providing the latest research related to programs and strategies for educators.** In this assignment, you will write a report to a building- or…

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    Assignment Prompt & Instructions

    **Reading and writing instruction must be grounded in research.  A valuable resource for educators is the What Works Clearinghouse  (WWC), a government agency providing the latest research related to  programs and strategies for educators.**
    In this assignment, you will write a report to a building- or  district-level leader to explain the merits of an evidence-based  strategy for reading or writing instruction.
    **Step 1. Identify**
    Identify a strategy commonly used to teach one component of reading or writing.
    **Step 2. Investigate**
    Access the What Works Clearinghouse (WWC) website and read through the research supporting that strategy.
    **Step 3. Synthesize**
    Compile your findings to determine the effectiveness of the strategy.
    **Step 4. Write**
    Write a report to your building  or district leader explaining the value of implementing this strategy.  Follow APA guidelines for in-text citations and include title page and a  references page with at least three references.

  • [Solved] Week 10 Discussion Response- Account for Management Decision Making

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    Executive Solution Overview

    **Colleague 1** Tameika Coates **The Strategic Power of Inquiry** There were systemic inventory anomalies in one of the multinational pharmaceutical supply chain companies where I work as a senior operations analyst, whose inventory problem was not being addressed by the established traditional audi…

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    Assignment Prompt & Instructions

    **Colleague 1**
    Tameika Coates
    **The Strategic Power of Inquiry**
    There were systemic inventory anomalies in one of the multinational pharmaceutical supply chain companies where I work as a senior operations analyst, whose inventory problem was not being addressed by the established traditional auditing guidelines. I refrained from purchasing the attribution being presented by management due to vendor unreliability. I applied some strategic reframing questions to conduct an executive briefing: What processes could be implemented in organizations without the intent to promote misreporting? What conflicts might occur between accuracy and efficiency in our measures of performance? What operational realities are we otherwise not factoring in in our present construct? This questionnaire's action made the established narratives wobbly, initiating further formation of systems analysis, which jeopardized our bonus structure for having disloyal warehouse employees during the capture of delays. Consequently, they promptly invented inventory confirmation. This was followed by policy restructuring, resulting from consultations with frontline workers, which narrowed the discrepancies by 61% over two fiscal quarters. At the same time, it boosted employee satisfaction metrics, indicating that psychological safety is catalytic to organizational learning, as revealed by Edmondson and Bransby (2023).
    The organizational defensiveness would be avoided because of the epistemological positioning of my inquiry. I also purposefully used relationship-building questions instead of telling, asking questions such as, "What are we possibly missing?" In which collective ownership was stated as a frame, thus avoiding it, it must be acceptable to make the accusation. Moreover, the careful use of gradual perception rather than confrontational criticism enabled leaders to build an alternative Darwinism step by step, rather than being forced to confront it. This strategy transformed acts that could have posed a threat into a joint knowledge-building process. Furthermore, I adjusted my questioning tone to an organizational focus on organizational preparedness, supported by the fact that time- and date-timely questions, asked at the right time, may provoke productive cognitive dissonance that enables paradigm shifting to counter the rapid reflex responses that typify premature inquiry (Gino and Staats, 2020).
    The use of retrospective analysis, complemented by current literature on adaptive leadership, helps highlight some opportunities to refine better praxis. Earlier application of generative questions — identifying potential possibilities and problems — would help future interventions, possibly with the question: What organizational circumstances would make accurate reporting feel intrinsically rewarding? Most importantly, Gino and Staats (2020) emphasized that the need to develop sustained questioning rhythms, rather than discrete interventions, fosters inquiry as an organizational infrastructure rather than a crisis response and externalizes sustained adaptive capacity. Moving on, I would initiate built-in reflection procedures that incorporate questioning as part of daily operations evaluations, such that interrogative practice becomes institutionalized in an organizational culture and does not rely solely on individual ability to generate questions in times of crisis.
    **References:**
    Edmondson, A. C., & Bransby, D. P. (2023). Psychological safety comes of age: Observed themes in an established literature. _Annual Review of Organizational Psychology and Organizational Behavior, 10_(1). [https://doi.org/10.1146/annurev-orgpsych-120920-055217Links to an external site.](https://doi.org/10.1146/annurev-orgpsych-120920-055217)
    Gino, F., & Staats, B. (2020). Why organizations don’t learn. _Harvard Business Review._ [https://hbr.org/2015/11/why-organizations-dont-learnLinks to an external site.](https://hbr.org/2015/11/why-organizations-dont-learn)
    **Colleague 2**
    Angela Eaker
    As a Basic Skills Instructor at the Coastal Adult Learning Center (CALC), I encountered a challenge where adult learners were consistently disengaged during virtual instruction. During a faculty meeting, I posed the critical question: _“How might our current instructional delivery methods be unintentionally limiting engagement for adult learners with diverse learning needs and technological barriers?”_ I deliberately framed the question to focus on systemic and instructional factors rather than student deficits, which helped foster a non-defensive, collaborative atmosphere among colleagues. I tailored my approach by using inclusive language and referencing shared goals—such as learner success and retention—to encourage open dialogue. This led to a productive discussion where faculty shared strategies and concerns, ultimately resulting in the adoption of more interactive tools, flexible pacing, and hybrid learning options. These changes improved learner participation and satisfaction.
    Reflecting on the situation and drawing from insights in strategic questioning frameworks, I realize that I could have involved learners more directly in the process. In the future, I would incorporate learner feedback through surveys or informal interviews before initiating the conversation with colleagues. This would ensure that the questions I raise are grounded in learner experience and promote equity in decision-making. Strategic questioning, when used thoughtfully, can uncover root causes and foster inclusive, solution-oriented dialogue (Brown & Isaacs, 2005).
    **Reference**
    Brown, J., & Isaacs, D. (2005). _The World Café: Shaping our futures through conversations that matter_. Berrett-Koehler Publishers.

  • [Solved] discussion

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    Executive Solution Overview

    – What is the primary purpose of the DSM-5-TR, and how is it intended to be used in clinical practice? – Describe the organization of the DSM-5-TR. What are the main sections and how are disorders grouped? – In your own words, what is the difference between a “diagnosis” and a “label,” and how can a…

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    Assignment Prompt & Instructions

    – What is the primary purpose of the DSM-5-TR, and how is it intended to be used in clinical practice?
    – Describe the organization of the DSM-5-TR. What are the main sections and how are disorders grouped?
    – In your own words, what is the difference between a “diagnosis” and a “label,” and how can a PMHNP reduce stigma when using diagnostic terms?

  • [Solved] Journal Response MODULE 6_DNP850

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    Executive Solution Overview

    JOURNAL – ## Module6JournalQuestion.docx – ## Module6JournalQuestion-Rubric.docx **## Module6JournalQuestion.docx** **Journal Response MODULE 6_DNP850** Consider your healthcare organization and the readings from this week. Considering the lessons this week on healthcare systems, reflect on a healt…

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    Assignment Prompt & Instructions

    JOURNAL

    – ## Module6JournalQuestion.docx

    – ## Module6JournalQuestion-Rubric.docx

    **## Module6JournalQuestion.docx**

    **Journal Response MODULE 6_DNP850**

    Consider your healthcare organization and the readings from this week. Considering the lessons this week on healthcare systems, reflect on a healthcare organization where you have previously worked or had clinical experience (do not name the site).

    Discuss the organization's culture and how you felt when you were in the organization over the period you were at the site.

    Was it a positive culture? Why or why not?

    How do you think staff, patients, and families perceived the organization? Consider all your senses in your response.

    What would your recommendation for the organization be as a DNP leader?

    Journal Response Expectations

    **Each short-answer Journal response will be a minimum of 300 words.**

    **No citation, reference, or APA style is necessary.**

    **## Module6JournalQuestion-Rubric.docx**

    Graduate Journal Question Rubric v1

    Course: DNP850 Sect1 Nursing Practice, Professionalism, and Scholarship

    ![](https://www.sweetstudy.com/questions/journal-response-module-6-dnp850)

    ![](https://www.sweetstudy.com/questions/journal-response-module-6-dnp850)

    **Overall Score**

    **Level 1**

    0

    points minimum

    **Level 2**

    14

    points minimum

    **Level 3**

    16

    points minimum

    **Level 4**

    20

    points minimum

    ## image1.png

    ## image2.png

    **## Module6JournalQuestion-Rubric.docx**

    Graduate Journal Question Rubric v1

    Course: DNP850 Sect1 Nursing Practice, Professionalism, and Scholarship

    ![](https://www.sweetstudy.com/questions/journal-response-module-6-dnp850)

    ![](https://www.sweetstudy.com/questions/journal-response-module-6-dnp850)

    **Overall Score**

    **Level 1**

    0

    points minimum

    **Level 2**

    14

    points minimum

    **Level 3**

    16

    points minimum

    **Level 4**

    20

    points minimum

    ## image1.png

    ## image2.png

    **## Module6JournalQuestion.docx**

    **Journal Response MODULE 6_DNP850**

    Consider your healthcare organization and the readings from this week. Considering the lessons this week on healthcare systems, reflect on a healthcare organization where you have previously worked or had clinical experience (do not name the site).

    Discuss the organization's culture and how you felt when you were in the organization over the period you were at the site.

    Was it a positive culture? Why or why not?

    How do you think staff, patients, and families perceived the organization? Consider all your senses in your response.

    What would your recommendation for the organization be as a DNP leader?

    Journal Response Expectations

    **Each short-answer Journal response will be a minimum of 300 words.**

    **No citation, reference, or APA style is necessary.**

    **## Module6JournalQuestion-Rubric.docx**

    Graduate Journal Question Rubric v1

    Course: DNP850 Sect1 Nursing Practice, Professionalism, and Scholarship

    ![](https://www.sweetstudy.com/questions/journal-response-module-6-dnp850)

    ![](https://www.sweetstudy.com/questions/journal-response-module-6-dnp850)

    **Overall Score**

    **Level 1**

    0

    points minimum

    **Level 2**

    14

    points minimum

    **Level 3**

    16

    points minimum

    **Level 4**

    20

    points minimum

    ## image1.png

    ## image2.png

    **## Module6JournalQuestion.docx**

    **Journal Response MODULE 6_DNP850**

    Consider your healthcare organization and the readings from this week. Considering the lessons this week on healthcare systems, reflect on a healthcare organization where you have previously worked or had clinical experience (do not name the site).

    Discuss the organization's culture and how you felt when you were in the organization over the period you were at the site.

    Was it a positive culture? Why or why not?

    How do you think staff, patients, and families perceived the organization? Consider all your senses in your response.

    What would your recommendation for the organization be as a DNP leader?

    Journal Response Expectations

    **Each short-answer Journal response will be a minimum of 300 words.**

    **No citation, reference, or APA style is necessary.**

    **## Module6JournalQuestion-Rubric.docx**

    Graduate Journal Question Rubric v1

    Course: DNP850 Sect1 Nursing Practice, Professionalism, and Scholarship

    ![](https://www.sweetstudy.com/questions/journal-response-module-6-dnp850)

    ![](https://www.sweetstudy.com/questions/journal-response-module-6-dnp850)

    **Overall Score**

    **Level 1**

    0

    points minimum

    **Level 2**

    14

    points minimum

    **Level 3**

    16

    points minimum

    **Level 4**

    20

    points minimum

    ## image1.png

    ## image2.png

    – 1
    – 2

  • [Solved] Nursing DNP Essential PowerPoint ASSIGNMENT 6

    ✓ Verified Academic Solution Available

    Executive Solution Overview

    ESSENTIAL OF DNP – ## Module6AssignmentQuestion.docx – ## Module6Assignment-RUBRIC.docx **## Module6AssignmentQuestion.docx** **DNP Essential PowerPoint** Based on what you have learned so far in this course, create a PowerPoint presentation that addresses each of the following points/questions. Be …

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    Assignment Prompt & Instructions

    ESSENTIAL OF DNP

    – ## Module6AssignmentQuestion.docx

    – ## Module6Assignment-RUBRIC.docx

    **## Module6AssignmentQuestion.docx**

    **DNP Essential PowerPoint**

    Based on what you have learned so far in this course, create a PowerPoint presentation that addresses each of the following points/questions. Be sure to completely answer all the questions for each bullet point. Use clear headings that allow your professor to know which bullet you are addressing on the slides in your presentation. Support your content with at least three (3) sources throughout your presentation. Make sure to reference the citations using the APA writing style for the presentation. Include a slide for your references at the end. Follow best practices for PowerPoint presentations related to text size, color, images, effects, wordiness, and multimedia enhancements. Review the rubric criteria for this assignment.

    The knowledge and expertise acquired in a DNP program assist us in meeting the changing needs of society and healthcare systems. Our preparation as a DNP enables us to utilize information technologies, provide evidence-based practice, develop healthcare policies, and provide leadership to meet the societal needs of a multicultural, complex healthcare environment.
    **This week you will prepare an APA-style PowerPoint presentation exploring the DNP Essentials and how they inform healthcare systems and your DNP project. In preparing your presentation, include the following:**

    **Title slide (1 slide)**

    **Overview of the DNP Essentials and their impact on your DNP project (3 – 4 slides)**

    **A slide for each of the Essentials and how you intend to meet the objectives for each of the eight DNP Essentials (9 – 11 slides)**

    **Closing slide and plan for meeting any of the Essentials where your project may contain a gap (3 slides)**

    **References (1 slide)**

    Study the required chapter(s) of the textbook and any additional recommended resources. Some answers may require you to do additional research on the Internet or in other reference sources. Choose your sources carefully.

    Consider the discussion and the any insights you gained from it.

    Review the rubric and the specifications below to ensure that your response aligns with all assignment expectations.

    Create your assignment submission and be sure to cite your sources, use APA style as required, check your spelling, and review the rubric.

    The following specifications are required for this assignment:

    **Length: 15 slides**

    **Structure: Include a title page and reference slide in APA style. These do not count towards the minimal word slide count for this assignment.**

    References: Use the appropriate APA citations and references for all resources utilized on each slide. Include at least FIVE (5) scholarly sources to support your claims.

    Scholarly articles
    **from**
    **2020 to 2025 only. (Within the last five years) Please review your spelling and the rubric.** **Please use North American peer-reviewed journals ONLY.DO NOT use any European Journal.**

    **Resources**

    Finkelman, A. (2023).
    _Professional nursing concepts: Competencies for quality leadership_ 5th ed.).Jones & Bartlett Learning.
    **Read chapters 8 & 9.**

    Chism, L. A. (2023).
    _The doctor of nursing_ _practice: A guidebook for role development and professional nursing practice_(5th ed.). Jones & Bartlett Learning.
    **Read chapters 16.**

    **Module 6 Additional Resources**

    American Association of Colleges of Nursing.(2006). The essentials of doctoral education for advanced nursing practice. https://www.aacnnursing.org/DNP/DNP-Essentials

    American Association of Colleges of Nursing.(2021) The essentials: Core competencies for professional nursing education. https://www.aacnnursing.org/Portals/42/

    AcademicNursing/pdf/Essentials-2021.pdf

    **“My DNP project aims to enhance glycemic control in Black adults aged 40–70 years with uncontrolled Type 2 Diabetes (HbA1c ≥9%) within a community-based primary care clinic by increasing the use of Continuous Glucose Monitors (CGMs)”.**

    **## Module6Assignment-RUBRIC.docx**

    10/27/25, 7:43 PM Preview Rubric: Graduate PowerPoint Assignment Rubric v1 – DNP850 Sect1 Nursing Practice, Professionalism, and Scholarship – Aspen University Classroom

    Criteria

    **Does Not Meet 0%**

    **Approaches 70%**

    **Meets 80%**

    **Exceeds 100%**

    **Criterion Score**

    Criteria

    **Does Not Meet 0%**

    **Approaches 70%**

    **Meets 80%**

    **Exceeds 100%**

    **Criterion Score**

    Graduate PowerPoint Assignment Rubric v1

    Course: DNP850 Sect1 Nursing Practice, Professionalism, and Scholarship

    Criteria

    **Does Not Meet 0%**

    **Approaches 70%**

    **Meets 80%**

    **Exceeds 100%**

    **Criterion Score**

    Content/Quality

    of Information

    Weight: 40%

    / 40

    0

    points

    Topic is inappropri

    –

    ate to assignment,

    not based on schol

    –

    arly information (if

    required), unclear

    and difficult to un

    –

    derstand, no hyper

    –

    links to credible

    sites; did not include

    required assignment

    components; slide

    notes missing (if

    required).

    28

    points

    Topic is mostly cov

    –

    ered and appropri

    –

    ate to assignment,

    but not based on

    scholarly informa

    –

    tion (if required);

    mostly clear and un

    –

    derstandable; may

    contain hyperlinks

    to non-credible

    sites; some of re

    –

    quired assignment

    components are

    present; minimal use

    of slide notes (if

    required).

    32

    points

    Good coverage of

    topic and appropri

    –

    ate to assignment;

    sound, research-

    based (if required)

    information; clear

    and understandable;

    hyperlinks to credi

    –

    ble sites; all required

    assignment compo

    –

    nents are accurate

    and present; slide

    notes used appro

    –

    priately (if required).

    points

    40

    In-depth coverage

    of topic and assign

    –

    ment components;

    outstanding clarity

    of information; de

    –

    tailed slide notes

    ensure all required

    content is well ex

    –

    plained (if required).

    | | | | | | |
    | — | — | — | — | — | — |
    | Presentation<br>Weight: 20% | 0 points<br>Unattractive; difficult to interpret; poor color choice and slide contrast; slide presentation unorganized; slide effects detract from the content; missing slide headings or sub-headings (if required for organization purposes); missing title/reference slides. | 14 points<br>Attractive but somewhat difficult to interpret; somewhat pleasing contrast between text and background, slide presentation may be somewhat disorganized; transitions and slide effects detract from the content; may be missing title or reference slides; included slide headings/sub-headings may detract from presentation. | 16 points<br>Attractive; easy to interpret, pleasing colors with strong contrast between text and background, slide presentation organized, good use of transitions and slide effects which enhance the presentation; both title and reference slides are present. Slide headings/sub-headings are used appropriately to organize the presentation. | 20 points<br>Excellent use of transitions and effects that enhance the presentation. Presentation is organized and designed for maximum impact of content. | / 20 |

    | | | | | | |
    | — | — | — | — | — | — |
    | Use of<br>Multimedia,<br>Graphics, Diagrams, and/or<br>Illustrations<br>Weight: 30% | 0 points<br>Does not include required multimedia, graphics, diagrams, and/or illustrations or they are irrelevant to topic or detract from slide content or presentation as a whole. | 21 points<br>Required multimedia, graphics, diagrams, and/or illustrations are generally relevant but some may not appropriately support the slide content. | 24 points<br>Required multimedia, graphics, diagrams, and/or illustrations are highly relevant and acceptably support the slide content; sized and positioned appropriately. | 30 points<br>Required multimedia, graphics, diagrams, and/or illustrations add clarity and sophistication to the presentation content; they improve the effectiveness of the presentation. | / 30 |

    Total

    / 100

    Writing,

    Mechanics, and

    APA Weight:

    %

    10

    / 10

    0

    points

    Style is inappropri

    –

    ate or does not ad

    –

    dress given audi

    –

    ence, purpose, etc.

    Inconsistent gram

    –

    mar, spelling, and

    punctuation; APA

    format and style are

    not evident

    throughout the

    presentation.

    7

    points

    Style is somewhat

    appropriate to given

    audience and pur

    –

    pose. Repetitive me

    –

    chanical errors dis

    –

    tract the reader.

    Inconsistencies in

    language, sentence

    structure, and/or

    word choice are

    present. There are

    missing APA ele

    –

    ments or some are

    incorrectly format

    –

    ted throughout the

    presentation.

    points

    8

    Style is appropriate

    to the given audi

    –

    ence and purpose.

    Word choice is spe

    –

    cific and purposeful,

    and somewhat var

    –

    ied throughout.

    Minimal mechanical

    or typographical er

    –

    rors are present, but

    are not overly dis

    –

    tracting. Reference

    slide and in-text ci

    –

    tations have few

    formatting errors.

    points

    10

    Style shows original

    –

    ity and creativity.

    Word choice is dy

    –

    namic and varied.

    Free of mechanical

    and typographical

    errors. Reference

    slide and other in-

    text citations are

    formatted correctly

    using APA elements.

    **Overall Score**

    **Level 1**

    0

    points minimum

    **Level 2**

    70

    points minimum

    **Level 3**

    80

    points minimum

    **Level 4**

    100

    points minimum

    1/4

    https://classroom.aspen.edu/d2l/le/content/114903/viewContent/6049702/View 1/4

    1/4

    **## Module6Assignment-RUBRIC.docx**

    10/27/25, 7:43 PM Preview Rubric: Graduate PowerPoint Assignment Rubric v1 – DNP850 Sect1 Nursing Practice, Professionalism, and Scholarship – Aspen University Classroom

    Criteria

    **Does Not Meet 0%**

    **Approaches 70%**

    **Meets 80%**

    **Exceeds 100%**

    **Criterion Score**

    Criteria

    **Does Not Meet 0%**

    **Approaches 70%**

    **Meets 80%**

    **Exceeds 100%**

    **Criterion Score**

    Graduate PowerPoint Assignment Rubric v1

    Course: DNP850 Sect1 Nursing Practice, Professionalism, and Scholarship

    Criteria

    **Does Not Meet 0%**

    **Approaches 70%**

    **Meets 80%**

    **Exceeds 100%**

    **Criterion Score**

    Content/Quality

    of Information

    Weight: 40%

    / 40

    0

    points

    Topic is inappropri

    –

    ate to assignment,

    not based on schol

    –

    arly information (if

    required), unclear

    and difficult to un

    –

    derstand, no hyper

    –

    links to credible

    sites; did not include

    required assignment

    components; slide

    notes missing (if

    required).

    28

    points

    Topic is mostly cov

    –

    ered and appropri

    –

    ate to assignment,

    but not based on

    scholarly informa

    –

    tion (if required);

    mostly clear and un

    –

    derstandable; may

    contain hyperlinks

    to non-credible

    sites; some of re

    –

    quired assignment

    components are

    present; minimal use

    of slide notes (if

    required).

    32

    points

    Good coverage of

    topic and appropri

    –

    ate to assignment;

    sound, research-

    based (if required)

    information; clear

    and understandable;

    hyperlinks to credi

    –

    ble sites; all required

    assignment compo

    –

    nents are accurate

    and present; slide

    notes used appro

    –

    priately (if required).

    points

    40

    In-depth coverage

    of topic and assign

    –

    ment components;

    outstanding clarity

    of information; de

    –

    tailed slide notes

    ensure all required

    content is well ex

    –

    plained (if required).

    | | | | | | |
    | — | — | — | — | — | — |
    | Presentation<br>Weight: 20% | 0 points<br>Unattractive; difficult to interpret; poor color choice and slide contrast; slide presentation unorganized; slide effects detract from the content; missing slide headings or sub-headings (if required for organization purposes); missing title/reference slides. | 14 points<br>Attractive but somewhat difficult to interpret; somewhat pleasing contrast between text and background, slide presentation may be somewhat disorganized; transitions and slide effects detract from the content; may be missing title or reference slides; included slide headings/sub-headings may detract from presentation. | 16 points<br>Attractive; easy to interpret, pleasing colors with strong contrast between text and background, slide presentation organized, good use of transitions and slide effects which enhance the presentation; both title and reference slides are present. Slide headings/sub-headings are used appropriately to organize the presentation. | 20 points<br>Excellent use of transitions and effects that enhance the presentation. Presentation is organized and designed for maximum impact of content. | / 20 |

    | | | | | | |
    | — | — | — | — | — | — |
    | Use of<br>Multimedia,<br>Graphics, Diagrams, and/or<br>Illustrations<br>Weight: 30% | 0 points<br>Does not include required multimedia, graphics, diagrams, and/or illustrations or they are irrelevant to topic or detract from slide content or presentation as a whole. | 21 points<br>Required multimedia, graphics, diagrams, and/or illustrations are generally relevant but some may not appropriately support the slide content. | 24 points<br>Required multimedia, graphics, diagrams, and/or illustrations are highly relevant and acceptably support the slide content; sized and positioned appropriately. | 30 points<br>Required multimedia, graphics, diagrams, and/or illustrations add clarity and sophistication to the presentation content; they improve the effectiveness of the presentation. | / 30 |

    Total

    / 100

    Writing,

    Mechanics, and

    APA Weight:

    %

    10

    / 10

    0

    points

    Style is inappropri

    –

    ate or does not ad

    –

    dress given audi

    –

    ence, purpose, etc.

    Inconsistent gram

    –

    mar, spelling, and

    punctuation; APA

    format and style are

    not evident

    throughout the

    presentation.

    7

    points

    Style is somewhat

    appropriate to given

    audience and pur

    –

    pose. Repetitive me

    –

    chanical errors dis

    –

    tract the reader.

    Inconsistencies in

    language, sentence

    structure, and/or

    word choice are

    present. There are

    missing APA ele

    –

    ments or some are

    incorrectly format

    –

    ted throughout the

    presentation.

    points

    8

    Style is appropriate

    to the given audi

    –

    ence and purpose.

    Word choice is spe

    –

    cific and purposeful,

    and somewhat var

    –

    ied throughout.

    Minimal mechanical

    or typographical er

    –

    rors are present, but

    are not overly dis

    –

    tracting. Reference

    slide and in-text ci

    –

    tations have few

    formatting errors.

    points

    10

    Style shows original

    –

    ity and creativity.

    Word choice is dy

    –

    namic and varied.

    Free of mechanical

    and typographical

    errors. Reference

    slide and other in-

    text citations are

    formatted correctly

    using APA elements.

    **Overall Score**

    **Level 1**

    0

    points minimum

    **Level 2**

    70

    points minimum

    **Level 3**

    80

    points minimum

    **Level 4**

    100

    points minimum

    1/4

    https://classroom.aspen.edu/d2l/le/content/114903/viewContent/6049702/View 1/4

    1/4

    **## Module6AssignmentQuestion.docx**

    **DNP Essential PowerPoint**

    Based on what you have learned so far in this course, create a PowerPoint presentation that addresses each of the following points/questions. Be sure to completely answer all the questions for each bullet point. Use clear headings that allow your professor to know which bullet you are addressing on the slides in your presentation. Support your content with at least three (3) sources throughout your presentation. Make sure to reference the citations using the APA writing style for the presentation. Include a slide for your references at the end. Follow best practices for PowerPoint presentations related to text size, color, images, effects, wordiness, and multimedia enhancements. Review the rubric criteria for this assignment.

    The knowledge and expertise acquired in a DNP program assist us in meeting the changing needs of society and healthcare systems. Our preparation as a DNP enables us to utilize information technologies, provide evidence-based practice, develop healthcare policies, and provide leadership to meet the societal needs of a multicultural, complex healthcare environment.
    **This week you will prepare an APA-style PowerPoint presentation exploring the DNP Essentials and how they inform healthcare systems and your DNP project. In preparing your presentation, include the following:**

    **Title slide (1 slide)**

    **Overview of the DNP Essentials and their impact on your DNP project (3 – 4 slides)**

    **A slide for each of the Essentials and how you intend to meet the objectives for each of the eight DNP Essentials (9 – 11 slides)**

    **Closing slide and plan for meeting any of the Essentials where your project may contain a gap (3 slides)**

    **References (1 slide)**

    Study the required chapter(s) of the textbook and any additional recommended resources. Some answers may require you to do additional research on the Internet or in other reference sources. Choose your sources carefully.

    Consider the discussion and the any insights you gained from it.

    Review the rubric and the specifications below to ensure that your response aligns with all assignment expectations.

    Create your assignment submission and be sure to cite your sources, use APA style as required, check your spelling, and review the rubric.

    The following specifications are required for this assignment:

    **Length: 15 slides**

    **Structure: Include a title page and reference slide in APA style. These do not count towards the minimal word slide count for this assignment.**

    References: Use the appropriate APA citations and references for all resources utilized on each slide. Include at least FIVE (5) scholarly sources to support your claims.

    Scholarly articles
    **from**
    **2020 to 2025 only. (Within the last five years) Please review your spelling and the rubric.** **Please use North American peer-reviewed journals ONLY.DO NOT use any European Journal.**

    **Resources**

    Finkelman, A. (2023).
    _Professional nursing concepts: Competencies for quality leadership_ 5th ed.).Jones & Bartlett Learning.
    **Read chapters 8 & 9.**

    Chism, L. A. (2023).
    _The doctor of nursing_ _practice: A guidebook for role development and professional nursing practice_(5th ed.). Jones & Bartlett Learning.
    **Read chapters 16.**

    **Module 6 Additional Resources**

    American Association of Colleges of Nursing.(2006). The essentials of doctoral education for advanced nursing practice. https://www.aacnnursing.org/DNP/DNP-Essentials

    American Association of Colleges of Nursing.(2021) The essentials: Core competencies for professional nursing education. https://www.aacnnursing.org/Portals/42/

    AcademicNursing/pdf/Essentials-2021.pdf

    **“My DNP project aims to enhance glycemic control in Black adults aged 40–70 years with uncontrolled Type 2 Diabetes (HbA1c ≥9%) within a community-based primary care clinic by increasing the use of Continuous Glucose Monitors (CGMs)”.**

    **## Module6Assignment-RUBRIC.docx**

    10/27/25, 7:43 PM Preview Rubric: Graduate PowerPoint Assignment Rubric v1 – DNP850 Sect1 Nursing Practice, Professionalism, and Scholarship – Aspen University Classroom

    Criteria

    **Does Not Meet 0%**

    **Approaches 70%**

    **Meets 80%**

    **Exceeds 100%**

    **Criterion Score**

    Criteria

    **Does Not Meet 0%**

    **Approaches 70%**

    **Meets 80%**

    **Exceeds 100%**

    **Criterion Score**

    Graduate PowerPoint Assignment Rubric v1

    Course: DNP850 Sect1 Nursing Practice, Professionalism, and Scholarship

    Criteria

    **Does Not Meet 0%**

    **Approaches 70%**

    **Meets 80%**

    **Exceeds 100%**

    **Criterion Score**

    Content/Quality

    of Information

    Weight: 40%

    / 40

    0

    points

    Topic is inappropri

    –

    ate to assignment,

    not based on schol

    –

    arly information (if

    required), unclear

    and difficult to un

    –

    derstand, no hyper

    –

    links to credible

    sites; did not include

    required assignment

    components; slide

    notes missing (if

    required).

    28

    points

    Topic is mostly cov

    –

    ered and appropri

    –

    ate to assignment,

    but not based on

    scholarly informa

    –

    tion (if required);

    mostly clear and un

    –

    derstandable; may

    contain hyperlinks

    to non-credible

    sites; some of re

    –

    quired assignment

    components are

    present; minimal use

    of slide notes (if

    required).

    32

    points

    Good coverage of

    topic and appropri

    –

    ate to assignment;

    sound, research-

    based (if required)

    information; clear

    and understandable;

    hyperlinks to credi

    –

    ble sites; all required

    assignment compo

    –

    nents are accurate

    and present; slide

    notes used appro

    –

    priately (if required).

    points

    40

    In-depth coverage

    of topic and assign

    –

    ment components;

    outstanding clarity

    of information; de

    –

    tailed slide notes

    ensure all required

    content is well ex

    –

    plained (if required).

    | | | | | | |
    | — | — | — | — | — | — |
    | Presentation<br>Weight: 20% | 0 points<br>Unattractive; difficult to interpret; poor color choice and slide contrast; slide presentation unorganized; slide effects detract from the content; missing slide headings or sub-headings (if required for organization purposes); missing title/reference slides. | 14 points<br>Attractive but somewhat difficult to interpret; somewhat pleasing contrast between text and background, slide presentation may be somewhat disorganized; transitions and slide effects detract from the content; may be missing title or reference slides; included slide headings/sub-headings may detract from presentation. | 16 points<br>Attractive; easy to interpret, pleasing colors with strong contrast between text and background, slide presentation organized, good use of transitions and slide effects which enhance the presentation; both title and reference slides are present. Slide headings/sub-headings are used appropriately to organize the presentation. | 20 points<br>Excellent use of transitions and effects that enhance the presentation. Presentation is organized and designed for maximum impact of content. | / 20 |

    | | | | | | |
    | — | — | — | — | — | — |
    | Use of<br>Multimedia,<br>Graphics, Diagrams, and/or<br>Illustrations<br>Weight: 30% | 0 points<br>Does not include required multimedia, graphics, diagrams, and/or illustrations or they are irrelevant to topic or detract from slide content or presentation as a whole. | 21 points<br>Required multimedia, graphics, diagrams, and/or illustrations are generally relevant but some may not appropriately support the slide content. | 24 points<br>Required multimedia, graphics, diagrams, and/or illustrations are highly relevant and acceptably support the slide content; sized and positioned appropriately. | 30 points<br>Required multimedia, graphics, diagrams, and/or illustrations add clarity and sophistication to the presentation content; they improve the effectiveness of the presentation. | / 30 |

    Total

    / 100

    Writing,

    Mechanics, and

    APA Weight:

    %

    10

    / 10

    0

    points

    Style is inappropri

    –

    ate or does not ad

    –

    dress given audi

    –

    ence, purpose, etc.

    Inconsistent gram

    –

    mar, spelling, and

    punctuation; APA

    format and style are

    not evident

    throughout the

    presentation.

    7

    points

    Style is somewhat

    appropriate to given

    audience and pur

    –

    pose. Repetitive me

    –

    chanical errors dis

    –

    tract the reader.

    Inconsistencies in

    language, sentence

    structure, and/or

    word choice are

    present. There are

    missing APA ele

    –

    ments or some are

    incorrectly format

    –

    ted throughout the

    presentation.

    points

    8

    Style is appropriate

    to the given audi

    –

    ence and purpose.

    Word choice is spe

    –

    cific and purposeful,

    and somewhat var

    –

    ied throughout.

    Minimal mechanical

    or typographical er

    –

    rors are present, but

    are not overly dis

    –

    tracting. Reference

    slide and in-text ci

    –

    tations have few

    formatting errors.

    points

    10

    Style shows original

    –

    ity and creativity.

    Word choice is dy

    –

    namic and varied.

    Free of mechanical

    and typographical

    errors. Reference

    slide and other in-

    text citations are

    formatted correctly

    using APA elements.

    **Overall Score**

    **Level 1**

    0

    points minimum

    **Level 2**

    70

    points minimum

    **Level 3**

    80

    points minimum

    **Level 4**

    100

    points minimum

    1/4

    https://classroom.aspen.edu/d2l/le/content/114903/viewContent/6049702/View 1/4

    1/4

    **## Module6AssignmentQuestion.docx**

    **DNP Essential PowerPoint**

    Based on what you have learned so far in this course, create a PowerPoint presentation that addresses each of the following points/questions. Be sure to completely answer all the questions for each bullet point. Use clear headings that allow your professor to know which bullet you are addressing on the slides in your presentation. Support your content with at least three (3) sources throughout your presentation. Make sure to reference the citations using the APA writing style for the presentation. Include a slide for your references at the end. Follow best practices for PowerPoint presentations related to text size, color, images, effects, wordiness, and multimedia enhancements. Review the rubric criteria for this assignment.

    The knowledge and expertise acquired in a DNP program assist us in meeting the changing needs of society and healthcare systems. Our preparation as a DNP enables us to utilize information technologies, provide evidence-based practice, develop healthcare policies, and provide leadership to meet the societal needs of a multicultural, complex healthcare environment.
    **This week you will prepare an APA-style PowerPoint presentation exploring the DNP Essentials and how they inform healthcare systems and your DNP project. In preparing your presentation, include the following:**

    **Title slide (1 slide)**

    **Overview of the DNP Essentials and their impact on your DNP project (3 – 4 slides)**

    **A slide for each of the Essentials and how you intend to meet the objectives for each of the eight DNP Essentials (9 – 11 slides)**

    **Closing slide and plan for meeting any of the Essentials where your project may contain a gap (3 slides)**

    **References (1 slide)**

    Study the required chapter(s) of the textbook and any additional recommended resources. Some answers may require you to do additional research on the Internet or in other reference sources. Choose your sources carefully.

    Consider the discussion and the any insights you gained from it.

    Review the rubric and the specifications below to ensure that your response aligns with all assignment expectations.

    Create your assignment submission and be sure to cite your sources, use APA style as required, check your spelling, and review the rubric.

    The following specifications are required for this assignment:

    **Length: 15 slides**

    **Structure: Include a title page and reference slide in APA style. These do not count towards the minimal word slide count for this assignment.**

    References: Use the appropriate APA citations and references for all resources utilized on each slide. Include at least FIVE (5) scholarly sources to support your claims.

    Scholarly articles
    **from**
    **2020 to 2025 only. (Within the last five years) Please review your spelling and the rubric.** **Please use North American peer-reviewed journals ONLY.DO NOT use any European Journal.**

    **Resources**

    Finkelman, A. (2023).
    _Professional nursing concepts: Competencies for quality leadership_ 5th ed.).Jones & Bartlett Learning.
    **Read chapters 8 & 9.**

    Chism, L. A. (2023).
    _The doctor of nursing_ _practice: A guidebook for role development and professional nursing practice_(5th ed.). Jones & Bartlett Learning.
    **Read chapters 16.**

    **Module 6 Additional Resources**

    American Association of Colleges of Nursing.(2006). The essentials of doctoral education for advanced nursing practice. https://www.aacnnursing.org/DNP/DNP-Essentials

    American Association of Colleges of Nursing.(2021) The essentials: Core competencies for professional nursing education. https://www.aacnnursing.org/Portals/42/

    AcademicNursing/pdf/Essentials-2021.pdf

    **“My DNP project aims to enhance glycemic control in Black adults aged 40–70 years with uncontrolled Type 2 Diabetes (HbA1c ≥9%) within a community-based primary care clinic by increasing the use of Continuous Glucose Monitors (CGMs)”.**

    **## Module6Assignment-RUBRIC.docx**

    10/27/25, 7:43 PM Preview Rubric: Graduate PowerPoint Assignment Rubric v1 – DNP850 Sect1 Nursing Practice, Professionalism, and Scholarship – Aspen University Classroom

    Criteria

    **Does Not Meet 0%**

    **Approaches 70%**

    **Meets 80%**

    **Exceeds 100%**

    **Criterion Score**

    Criteria

    **Does Not Meet 0%**

    **Approaches 70%**

    **Meets 80%**

    **Exceeds 100%**

    **Criterion Score**

    Graduate PowerPoint Assignment Rubric v1

    Course: DNP850 Sect1 Nursing Practice, Professionalism, and Scholarship

    Criteria

    **Does Not Meet 0%**

    **Approaches 70%**

    **Meets 80%**

    **Exceeds 100%**

    **Criterion Score**

    Content/Quality

    of Information

    Weight: 40%

    / 40

    0

    points

    Topic is inappropri

    –

    ate to assignment,

    not based on schol

    –

    arly information (if

    required), unclear

    and difficult to un

    –

    derstand, no hyper

    –

    links to credible

    sites; did not include

    required assignment

    components; slide

    notes missing (if

    required).

    28

    points

    Topic is mostly cov

    –

    ered and appropri

    –

    ate to assignment,

    but not based on

    scholarly informa

    –

    tion (if required);

    mostly clear and un

    –

    derstandable; may

    contain hyperlinks

    to non-credible

    sites; some of re

    –

    quired assignment

    components are

    present; minimal use

    of slide notes (if

    required).

    32

    points

    Good coverage of

    topic and appropri

    –

    ate to assignment;

    sound, research-

    based (if required)

    information; clear

    and understandable;

    hyperlinks to credi

    –

    ble sites; all required

    assignment compo

    –

    nents are accurate

    and present; slide

    notes used appro

    –

    priately (if required).

    points

    40

    In-depth coverage

    of topic and assign

    –

    ment components;

    outstanding clarity

    of information; de

    –

    tailed slide notes

    ensure all required

    content is well ex

    –

    plained (if required).

    | | | | | | |
    | — | — | — | — | — | — |
    | Presentation<br>Weight: 20% | 0 points<br>Unattractive; difficult to interpret; poor color choice and slide contrast; slide presentation unorganized; slide effects detract from the content; missing slide headings or sub-headings (if required for organization purposes); missing title/reference slides. | 14 points<br>Attractive but somewhat difficult to interpret; somewhat pleasing contrast between text and background, slide presentation may be somewhat disorganized; transitions and slide effects detract from the content; may be missing title or reference slides; included slide headings/sub-headings may detract from presentation. | 16 points<br>Attractive; easy to interpret, pleasing colors with strong contrast between text and background, slide presentation organized, good use of transitions and slide effects which enhance the presentation; both title and reference slides are present. Slide headings/sub-headings are used appropriately to organize the presentation. | 20 points<br>Excellent use of transitions and effects that enhance the presentation. Presentation is organized and designed for maximum impact of content. | / 20 |

    | | | | | | |
    | — | — | — | — | — | — |
    | Use of<br>Multimedia,<br>Graphics, Diagrams, and/or<br>Illustrations<br>Weight: 30% | 0 points<br>Does not include required multimedia, graphics, diagrams, and/or illustrations or they are irrelevant to topic or detract from slide content or presentation as a whole. | 21 points<br>Required multimedia, graphics, diagrams, and/or illustrations are generally relevant but some may not appropriately support the slide content. | 24 points<br>Required multimedia, graphics, diagrams, and/or illustrations are highly relevant and acceptably support the slide content; sized and positioned appropriately. | 30 points<br>Required multimedia, graphics, diagrams, and/or illustrations add clarity and sophistication to the presentation content; they improve the effectiveness of the presentation. | / 30 |

    Total

    / 100

    Writing,

    Mechanics, and

    APA Weight:

    %

    10

    / 10

    0

    points

    Style is inappropri

    –

    ate or does not ad

    –

    dress given audi

    –

    ence, purpose, etc.

    Inconsistent gram

    –

    mar, spelling, and

    punctuation; APA

    format and style are

    not evident

    throughout the

    presentation.

    7

    points

    Style is somewhat

    appropriate to given

    audience and pur

    –

    pose. Repetitive me

    –

    chanical errors dis

    –

    tract the reader.

    Inconsistencies in

    language, sentence

    structure, and/or

    word choice are

    present. There are

    missing APA ele

    –

    ments or some are

    incorrectly format

    –

    ted throughout the

    presentation.

    points

    8

    Style is appropriate

    to the given audi

    –

    ence and purpose.

    Word choice is spe

    –

    cific and purposeful,

    and somewhat var

    –

    ied throughout.

    Minimal mechanical

    or typographical er

    –

    rors are present, but

    are not overly dis

    –

    tracting. Reference

    slide and in-text ci

    –

    tations have few

    formatting errors.

    points

    10

    Style shows original

    –

    ity and creativity.

    Word choice is dy

    –

    namic and varied.

    Free of mechanical

    and typographical

    errors. Reference

    slide and other in-

    text citations are

    formatted correctly

    using APA elements.

    **Overall Score**

    **Level 1**

    0

    points minimum

    **Level 2**

    70

    points minimum

    **Level 3**

    80

    points minimum

    **Level 4**

    100

    points minimum

    1/4

    https://classroom.aspen.edu/d2l/le/content/114903/viewContent/6049702/View 1/4

    1/4

    – 1
    – 2

  • [Solved] Heed wk 3

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    Executive Solution Overview

    – ## study_guide_17a_pathway_to_medical_device_approval_slides_1_15_grlr_v1.docx – ## Heedwk3assign.docx – 15_grlr_part_1_validation_overview_v3.pdf **## study_guide_17a_pathway_to_medical_device_approval_slides_1_15_grlr_v1.docx** **![](https://www.sweetstudy.com/quest…

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    Assignment Prompt & Instructions

    – ## study_guide_17a_pathway_to_medical_device_approval_slides_1_15_grlr_v1.docx

    – ## Heedwk3assign.docx

    – 15_grlr_part_1_validation_overview_v3.pdf

    **## study_guide_17a_pathway_to_medical_device_approval_slides_1_15_grlr_v1.docx**

    **![](https://www.sweetstudy.com/questions/heed-wk-3)**

    **Global Regulatory and Legal Requirements of Quality.v1**

    **17a Study Guide- Pathway to Medical Device Approval Part 1**

    1.
    Which branch of FDA Approves Medical Device products?

    2. The Approval Pathway is Based on Device Risk. Fill in the following table:

    | | | |
    | — | — | — |
    | Medical Device Risk Classification |
    | Classification | Define | Examples |
    | Class I | | |
    | Class II | | |
    | Class III | | |

    3. Explain the following:

    | | |
    | — | — |
    | FDA Submission Types |
    | PMA | 510(k) |
    | | |

    4. What do you think is meant by “least burdensome” on slide 6, and why is this important (refer to slides 12-13)?

    5. Define Predicate (slide 6):

    6. Define DeNovo (slide 6):

    7. What is a Pre-Sub, and why is this beneficial for companies?

    8. On slide 11, a 510(k) is to request ________________ for your product to be on the market, whereas a Pre-Market Approval application is to request approval.

    9. Explain Substantial Equivalence

    **image1.png**

    **## Heedwk3assign.docx**

    ![](https://www.sweetstudy.com/questions/heed-wk-3)Version 6

    **Homework Assignment 3**

    Pathway for Patient Health

    Global Regulatory and Legal Requirements of Quality

    | |
    | — |
    | **Complete this assignment by typing your answers into this Word document** |

    First Name:

    Last Name:

    Email address:

    · Save this file as: First Name Last Name GRLR Project 3 (e.g. Marla Phillips GRLR Project 3.doc)

    · Submit this assignment in Canvas

    · Assignment due dates are as listed in the syllabus.

    · Generative AI use is not allowed on this assignment.

    | |
    | — |
    | **This assignment must be submitted by the due date that was provided to you by 11:59pm (EST)** |

    **Review the FDA Guidance on Cleaning Validation, and describe:**

    1. What series of events (plural) caused the FDA to focus on how equipment is cleaned, and when did that occur? (Note: this is described in the FDA guidance document)

    2. Describe what can be tested in order to determine if the equipment is clean. (Note: what would you test and give a short narrative description on why)

    3. Describe 2 examples of why it is critical to document the cleaning process.

    4. What types of contamination can be present in the equipment? (list 3 types)

    5. An entrapment area (a.k.a. dead-legs) in equipment is a place where part of the product/formulation can become trapped/lodged in the equipment (for example, where two parts of the equipment are joined together, where there is curvature in the equipment, etc.), and is challenging to flush, rinse or wipe clean. The entrapped product/formulation can become dislodged during the production of another product and cause cross-contamination. How could you reduce the risk of entrapment?

    (
    **Hint:** See the assignment rubric below to ensure that you are providing a complete answer.)

    **Resource you will need for this Assignment:**

    · Lecture notes

    · Review the FDA Guidance on Cleaning Validation.
    [Access Cleaning Validation Document](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/inspection-guides/validation-cleaning-processes-793)

    | | |
    | — | — |
    | **Grading Comments for Question 1** | **Score for Question 1**<br>**(Possible 2)** |
    | | |

    | | |
    | — | — |
    | **Grading Comments for Question 2** | **Score for Question 2**<br>**(Possible 2)** |
    | | |

    | | |
    | — | — |
    | **Grading Comments for Question 3** | **Score for Question 1**<br>**(Possible 2)** |
    | | |

    | | |
    | — | — |
    | **Grading Comments for Question 4** | **Score for Question 2**<br>**(Possible 2)** |
    | | |

    | | |
    | — | — |
    | **Grading Comments for Question 5** | **Score for Question 1**<br>**(Possible 2)** |
    | | |

    **Rubric:**

    | | | |
    | — | — | — |
    | | **Does not meet requirements** | **Excellent** |
    | **Question 1** | No engagement/effort with this question. (0)<br>Use of AI (0) | The student identified a logical series of events that led to the focus on cleaning validation. (1-2) |
    | **Question 2** | No engagement/effort with this question. (0)<br>Use of AI (0) | The student identified at least one example of what can be tested (1-2) |
    | **Question 3** | No engagement/effort with this question. (0)<br>Use of AI (0) | The student explained why it is critical to document the cleaning process. (1-2) |
    | **Question 4** | No engagement/effort with this question. (0)<br>Use of AI (0) | The student lists 3 types of contamination. (1-2) |
    | **Question 5** | No engagement/effort with this question. (0)<br>Use of AI (0) | The student explained how to reduce the risk of entrapment. (1-2) |

    Marla A. Phillips, Ph.D. | CEO and President | Pathway for Patient Health

    Marla.Phillips@Pathway4PH.org | 513-238-4338 | www.Pathway4PH.org

    ## image1.png

    **15_grlr_part_1_validation_overview_v3.pdf**

    This file is too large to display. [View in new window](https://www.sweetstudy.com/files/15-grlr-part-1-validation-overview-v3-pdf)

    **15_grlr_part_1_validation_overview_v3.pdf**

    This file is too large to display. [View in new window](https://www.sweetstudy.com/files/15-grlr-part-1-validation-overview-v3-pdf)

    **## study_guide_17a_pathway_to_medical_device_approval_slides_1_15_grlr_v1.docx**

    **![](https://www.sweetstudy.com/questions/heed-wk-3)**

    **Global Regulatory and Legal Requirements of Quality.v1**

    **17a Study Guide- Pathway to Medical Device Approval Part 1**

    1.
    Which branch of FDA Approves Medical Device products?

    2. The Approval Pathway is Based on Device Risk. Fill in the following table:

    | | | |
    | — | — | — |
    | Medical Device Risk Classification |
    | Classification | Define | Examples |
    | Class I | | |
    | Class II | | |
    | Class III | | |

    3. Explain the following:

    | | |
    | — | — |
    | FDA Submission Types |
    | PMA | 510(k) |
    | | |

    4. What do you think is meant by “least burdensome” on slide 6, and why is this important (refer to slides 12-13)?

    5. Define Predicate (slide 6):

    6. Define DeNovo (slide 6):

    7. What is a Pre-Sub, and why is this beneficial for companies?

    8. On slide 11, a 510(k) is to request ________________ for your product to be on the market, whereas a Pre-Market Approval application is to request approval.

    9. Explain Substantial Equivalence

    **image1.png**

    **## Heedwk3assign.docx**

    ![](https://www.sweetstudy.com/questions/heed-wk-3)Version 6

    **Homework Assignment 3**

    Pathway for Patient Health

    Global Regulatory and Legal Requirements of Quality

    | |
    | — |
    | **Complete this assignment by typing your answers into this Word document** |

    First Name:

    Last Name:

    Email address:

    · Save this file as: First Name Last Name GRLR Project 3 (e.g. Marla Phillips GRLR Project 3.doc)

    · Submit this assignment in Canvas

    · Assignment due dates are as listed in the syllabus.

    · Generative AI use is not allowed on this assignment.

    | |
    | — |
    | **This assignment must be submitted by the due date that was provided to you by 11:59pm (EST)** |

    **Review the FDA Guidance on Cleaning Validation, and describe:**

    1. What series of events (plural) caused the FDA to focus on how equipment is cleaned, and when did that occur? (Note: this is described in the FDA guidance document)

    2. Describe what can be tested in order to determine if the equipment is clean. (Note: what would you test and give a short narrative description on why)

    3. Describe 2 examples of why it is critical to document the cleaning process.

    4. What types of contamination can be present in the equipment? (list 3 types)

    5. An entrapment area (a.k.a. dead-legs) in equipment is a place where part of the product/formulation can become trapped/lodged in the equipment (for example, where two parts of the equipment are joined together, where there is curvature in the equipment, etc.), and is challenging to flush, rinse or wipe clean. The entrapped product/formulation can become dislodged during the production of another product and cause cross-contamination. How could you reduce the risk of entrapment?

    (
    **Hint:** See the assignment rubric below to ensure that you are providing a complete answer.)

    **Resource you will need for this Assignment:**

    · Lecture notes

    · Review the FDA Guidance on Cleaning Validation.
    [Access Cleaning Validation Document](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/inspection-guides/validation-cleaning-processes-793)

    | | |
    | — | — |
    | **Grading Comments for Question 1** | **Score for Question 1**<br>**(Possible 2)** |
    | | |

    | | |
    | — | — |
    | **Grading Comments for Question 2** | **Score for Question 2**<br>**(Possible 2)** |
    | | |

    | | |
    | — | — |
    | **Grading Comments for Question 3** | **Score for Question 1**<br>**(Possible 2)** |
    | | |

    | | |
    | — | — |
    | **Grading Comments for Question 4** | **Score for Question 2**<br>**(Possible 2)** |
    | | |

    | | |
    | — | — |
    | **Grading Comments for Question 5** | **Score for Question 1**<br>**(Possible 2)** |
    | | |

    **Rubric:**

    | | | |
    | — | — | — |
    | | **Does not meet requirements** | **Excellent** |
    | **Question 1** | No engagement/effort with this question. (0)<br>Use of AI (0) | The student identified a logical series of events that led to the focus on cleaning validation. (1-2) |
    | **Question 2** | No engagement/effort with this question. (0)<br>Use of AI (0) | The student identified at least one example of what can be tested (1-2) |
    | **Question 3** | No engagement/effort with this question. (0)<br>Use of AI (0) | The student explained why it is critical to document the cleaning process. (1-2) |
    | **Question 4** | No engagement/effort with this question. (0)<br>Use of AI (0) | The student lists 3 types of contamination. (1-2) |
    | **Question 5** | No engagement/effort with this question. (0)<br>Use of AI (0) | The student explained how to reduce the risk of entrapment. (1-2) |

    Marla A. Phillips, Ph.D. | CEO and President | Pathway for Patient Health

    Marla.Phillips@Pathway4PH.org | 513-238-4338 | www.Pathway4PH.org

    ## image1.png

    **15_grlr_part_1_validation_overview_v3.pdf**

    This file is too large to display. [View in new window](https://www.sweetstudy.com/files/15-grlr-part-1-validation-overview-v3-pdf)

    **## study_guide_17a_pathway_to_medical_device_approval_slides_1_15_grlr_v1.docx**

    **![](https://www.sweetstudy.com/questions/heed-wk-3)**

    **Global Regulatory and Legal Requirements of Quality.v1**

    **17a Study Guide- Pathway to Medical Device Approval Part 1**

    1.
    Which branch of FDA Approves Medical Device products?

    2. The Approval Pathway is Based on Device Risk. Fill in the following table:

    | | | |
    | — | — | — |
    | Medical Device Risk Classification |
    | Classification | Define | Examples |
    | Class I | | |
    | Class II | | |
    | Class III | | |

    3. Explain the following:

    | | |
    | — | — |
    | FDA Submission Types |
    | PMA | 510(k) |
    | | |

    4. What do you think is meant by “least burdensome” on slide 6, and why is this important (refer to slides 12-13)?

    5. Define Predicate (slide 6):

    6. Define DeNovo (slide 6):

    7. What is a Pre-Sub, and why is this beneficial for companies?

    8. On slide 11, a 510(k) is to request ________________ for your product to be on the market, whereas a Pre-Market Approval application is to request approval.

    9. Explain Substantial Equivalence

    **image1.png**

    **## Heedwk3assign.docx**

    ![](https://www.sweetstudy.com/questions/heed-wk-3)Version 6

    **Homework Assignment 3**

    Pathway for Patient Health

    Global Regulatory and Legal Requirements of Quality

    | |
    | — |
    | **Complete this assignment by typing your answers into this Word document** |

    First Name:

    Last Name:

    Email address:

    · Save this file as: First Name Last Name GRLR Project 3 (e.g. Marla Phillips GRLR Project 3.doc)

    · Submit this assignment in Canvas

    · Assignment due dates are as listed in the syllabus.

    · Generative AI use is not allowed on this assignment.

    | |
    | — |
    | **This assignment must be submitted by the due date that was provided to you by 11:59pm (EST)** |

    **Review the FDA Guidance on Cleaning Validation, and describe:**

    1. What series of events (plural) caused the FDA to focus on how equipment is cleaned, and when did that occur? (Note: this is described in the FDA guidance document)

    2. Describe what can be tested in order to determine if the equipment is clean. (Note: what would you test and give a short narrative description on why)

    3. Describe 2 examples of why it is critical to document the cleaning process.

    4. What types of contamination can be present in the equipment? (list 3 types)

    5. An entrapment area (a.k.a. dead-legs) in equipment is a place where part of the product/formulation can become trapped/lodged in the equipment (for example, where two parts of the equipment are joined together, where there is curvature in the equipment, etc.), and is challenging to flush, rinse or wipe clean. The entrapped product/formulation can become dislodged during the production of another product and cause cross-contamination. How could you reduce the risk of entrapment?

    (
    **Hint:** See the assignment rubric below to ensure that you are providing a complete answer.)

    **Resource you will need for this Assignment:**

    · Lecture notes

    · Review the FDA Guidance on Cleaning Validation.
    [Access Cleaning Validation Document](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/inspection-guides/validation-cleaning-processes-793)

    | | |
    | — | — |
    | **Grading Comments for Question 1** | **Score for Question 1**<br>**(Possible 2)** |
    | | |

    | | |
    | — | — |
    | **Grading Comments for Question 2** | **Score for Question 2**<br>**(Possible 2)** |
    | | |

    | | |
    | — | — |
    | **Grading Comments for Question 3** | **Score for Question 1**<br>**(Possible 2)** |
    | | |

    | | |
    | — | — |
    | **Grading Comments for Question 4** | **Score for Question 2**<br>**(Possible 2)** |
    | | |

    | | |
    | — | — |
    | **Grading Comments for Question 5** | **Score for Question 1**<br>**(Possible 2)** |
    | | |

    **Rubric:**

    | | | |
    | — | — | — |
    | | **Does not meet requirements** | **Excellent** |
    | **Question 1** | No engagement/effort with this question. (0)<br>Use of AI (0) | The student identified a logical series of events that led to the focus on cleaning validation. (1-2) |
    | **Question 2** | No engagement/effort with this question. (0)<br>Use of AI (0) | The student identified at least one example of what can be tested (1-2) |
    | **Question 3** | No engagement/effort with this question. (0)<br>Use of AI (0) | The student explained why it is critical to document the cleaning process. (1-2) |
    | **Question 4** | No engagement/effort with this question. (0)<br>Use of AI (0) | The student lists 3 types of contamination. (1-2) |
    | **Question 5** | No engagement/effort with this question. (0)<br>Use of AI (0) | The student explained how to reduce the risk of entrapment. (1-2) |

    Marla A. Phillips, Ph.D. | CEO and President | Pathway for Patient Health

    Marla.Phillips@Pathway4PH.org | 513-238-4338 | www.Pathway4PH.org

    ## image1.png

    **15_grlr_part_1_validation_overview_v3.pdf**

    This file is too large to display. [View in new window](https://www.sweetstudy.com/files/15-grlr-part-1-validation-overview-v3-pdf)

    – 1
    – 2
    – 3

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    Build a model( as realistic as possible no AI pictures of a brain (do not trace or draw a brain) using things you have around your house. Be creative! There is no need to buy extra materials to do this. Make sure you include all four lobes of the brain, label them, and give a short explanation of where the lobe is and important features of the lobe.

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    2 pages APA In this assignment, you will analyze current data mining practices and evaluate the pros and cons of data mining. You will research an example of a company that has successfully practiced data mining to forecast the market and a company that could not leverage data mining effectively to …

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    2 pages APA
    In this assignment, you will analyze current data mining practices and evaluate the pros and cons of data mining. You will research an example of a company that has successfully practiced data mining to forecast the market and a company that could not leverage data mining effectively to forecast the market.
    In your paper,
    – Discuss the industry standards for data mining best practices.
    – Identify pitfalls in data mining, including practices that should be avoided.
    – Provide an example of a company that has successfully practiced data mining to forecast the market.
    – Explain the company’s forecasting model.
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    – What pitfalls did the organization fall into?
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