Category: Other

Assignment 4 Week 12 Completion requirements Opened: Wednesday, 27 November 2024, 12:00 AM Due: Wednesday, 18 December 2024, 11:59 PM As head of the Regulatory Affairs team in a large Finished Pharmaceutical manufacturing company you have been tasked with laying out a plan for dealing with a new drug application. This drug has just passed development stage and clinical trials and is ready for implementation at the planned site of manufacture, in Dublin. Prior to this you will need to review the work completed in the clinical trials, discuss what you would expect to see upon your review and what you will need for the submission. The drug itself is new with no competing drug on the market and is of great interest to the European market. Assess what route you would take for submission outlining the process and the choice of route. The company itself is a leading manufacturing of similar drugs. Please provide detail on what you would include in this plan under the headings listed below. Title: Provide a suitable and specific title to represent the content of the report. Introduction: Short Introduction with references. Aims: Specify the aims that you will be aiming to achieve. Discussion: Main Content (this section can have headings and sub-headings as well). Sub-headings: Based on the different stages of the key areas impacted in your Pharma company. Flow diagram (if any): Neatly presented (self-made and labelled). Tables (If any): (self-made linked with the flow diagram and labelled). Explanations: For each stage in detail. Conclusion and recommendation: Report. References: Include any References (Harvard Style) Submission Details: Submit project in one MS Word document in Moodle with a word count as below by Weds 18th Dec. Total: 3500 words Max Marks 40% The reason what you will find that the staff is too long is because some basic information touched must be included things like : maintaining … (E.C., EudraLex The Rules Governing Medicinal Products in the European Union Volume 4 EU Guidelines for Good Manufacturing Practice for Medicinal Products for Human and Veterinary Use Part 1 Chapter 2: Personnel, 2013). Production Production operations are required to comply with Good Manufacturing Practices (GMP) to guarantee the quality of products that fulfill necessary manufacturing and marketing authorizations. These procedures must be executed under the supervision of qualified personnel …. Guidelines and regulations cited as per topics Generalised solution for this assignment is not permitted as he wants things I gave examples about, please help me to shorten it as I am ‘dying’ of exhaustion and I am very very too late (1 day if possible) and happy christmas

I upload the assignment Guid on the file. Please follow the instructions and dont write more than 2000 words Also i would like you to Run SPSS and screenshot put it in the appendix . also write literature review as well.
Also upload the book of “Understanding_research_philosophy_and_approaches_to_theory_development ” that its can help you

Group dynamics shape individual actions and interactions and influence human behavior. A hands-on experience allows students to observe theories in practice, such as social learning and group dynamics, which enhances analytical skills. Observing real-world group behaviors encourages opportunities to identify effective intervention strategies and improve their ability to support clients in group settings.
Within a seven-day period during this class, observe in your community three different groups from a distance. Choose three different groups to observe. For example, you can observe a sports practice, work group, student ministry group, study group, play group. You should be observing for no less than an hour to ensure that you can fully develop an understanding of the group you are observing.
Be sure to not engage or be integrated into the group as this is an observation assignment, solely.
You will use the “Groups and Human Behavior Observation Worksheet” attached to note your observations in response to each section on the worksheet. Once you have completed the observations and each section on the worksheet, you will complete a reflection portion and respond to each question/statement listed within the worksheet.
Prepare this assignment according to the guidelines found in the APA Style Guide, located in the Student Success Center.
This assignment uses a rubric. Please review the rubric prior to beginning the assignment to become familiar with the expectations for successful completion.
You are required to submit this assignment to LopesWrite. A link to the LopesWrite technical support articles is located in Class Resources if you need assistance.
This assignment is aligned to the following Social Work Competencies:
2: Advance Human Rights and Social, Racial, Economic, and Environmental Justice
6: Engage with Individuals, Families, Groups, Organizations, and Communities
Attachments

To be completed after reading Chapter 5: Software and Apps
In Chapter 5, you learned to name, visually identify, and describe popular productivity apps including word processing, spreadsheet, presentation, and database software and their key features. You also learned to describe different types of application software, including graphics software, drawing apps, paint apps and photo editing apps.  Productivity apps are used in both personal and business settings. Many of these apps run on your desktop, in a browser, or on a mobile device or tablet. With word processing software, you can format text and documents and manage documents. With spreadsheet software, you can create and manage workbooks, analyze data, create charts, and format spreadsheets. With presentation software, you can create slides, add transitions between slides, use presentation templates, and include animations on elements in slides, to make more effective presentations. You also can format, share, and display presentations. With database software, you can create database tables, reports, and forms; create and perform queries and manage databases.
1. Experiment with using apps from any two of the productivity suites (email apps) listed in Table 5-3 (page CC 5-4). Can you find reasons to choose one over the other? Explain.
2. Compare photo or image editing programs that work on your personal computer with similar apps that work on your phone.
* Which do you find easier or more convenient to use and why?
3. Read an article about how Big Data enables companies to track large amounts of personal information. What types of information do companies track?
* Are you concerned about your own privacy?
Defend your position and be prepared to debate by commenting on your classmate’s posts.
IMPORTANT: 
Initial Response
* Answer ALL questions, your main/initial post should be a minimum of 2-3 paragraphs.  (200 words minimum). HINT: Answering and elaborating on ALL questions will assist you with accomplishing your 200 words minimum.
* Use a combination of your textbook reading material, related research information you may have discovered, and/or related life experiences to back up your response.

Can you plaese answer application questions without using AI generator. I added some information about me that would help the application
1.) Please briefly tell why you want to be an occupational therapist and where you gained information about being an OT. (Please be concise any content beyond 500 words will not be read)
Throughout the years of school I always been passionate about working for people. I’ve never knew about occupational therapy until 5 years ago. After lots of volunteering at care homes. Volunteering at the surrey memorial hospital and working as a behaviour interventionist I’ve empathized with individuals with disabilities. Which is why I majored in psychology to understand and learn about different disorders and disabilities. On my journey to discovery there was occupational therapist working along side in every department I’ve volunteered/ worked in. At symbiosis pediatric therapy I began my journey as a behaviour interventionist and through that I’ve got to do a practicum at symbiosis with occupational therapist. During my practicum journey I’ve interviewed many occupational therapist made connections with them. I’ve learned about proprioception vestibular input started understanding how important sensory regulation in to autistic children. As an occupational therapist assistant I’ve gained a lot of knowledge and I’m extremely passionate to work in this field since it aligns with my higher sense of self since I’ve been working with them all these years I’m extremely passionate and I’ll 100 % know this is something I would like to do and elaborate on during my life time. I’ve gained lots of knowledge about proposition vestibular how the body processing things. A lot of skills developed working with fine motor gross motor and sensory processing for being a OTA for past 3 years. I’ve gained tremendous knowledge on how to work on life skills and working with autistic children from the ages of 2-19 I’m deeply passionate elaborating and working with kids in the near future after I get my full license as an occupational therapist.
2.) Tell us about the ways you engage with your community, including social, political, recreational, volunteer and/or paid work experiences?
Please let them know I have worked as an occupational therapy assistant at symbiosis pediatric therapy I have a lot of knowledge when it comes to skills like fine motor gross motor sensory processing. I’ve shadowed Occupational therapist and behaviour consultants in their sessions. Enjoy helping out children with disabilities. Also have volunteer experience with helping visitors patients find their way in the hospital.
3.) 27. How would you describe your communication style? How do you navigate disagreements or differing perspectives?
I like to have open communication and I truly feel when it comes to disagreements or differing perspectives it’s important to aknowledge them but also not to feel discouraged if there’s difference in opinions it’s important to come in the middle where both parties are in agreement
4.) Tell us about your understanding and/or experiences related to culture, equity and justice.
5.)The MSc(OT) degree is a demanding program. Tell us about how you manage multiple and/or complex commitments and responsibilities.
6.) What have you learned about leadership through either being a leader or observing others in leadership roles?

From The Field Guide to the 6DsLinks to an external site. book, choose one of these three cases for this assignment (do not choose any other cases):
Case D4.2 How We Achieved Lean Improvements with Learning Transfer (Hypertherm) (p. 423 – 430) OR
Case D5.1 How We Engage Key Contributors to Disseminate Corporate Culture (Promon Engenharia) (p. 469 – 473) OR
Case D5.3 How We Engage Participants for Optimal Learning Transfer (Tata Motors Limited) (p. 481 – 487)

For this assignment, you will create a deliverable of your choice (written document, infographic, PowerPoint, video, etc.) that communicates the information below. Did you know?? Communicating information in a creative format is a very useful skill for today’s business professionals. See the handout Handout – ‘How To’ Resources for Creative Deliverables (Canvas).pdfOpen this document with ReadSpeaker docReader Download Handout – ‘How To’ Resources for Creative Deliverables (Canvas).pdfOpen this document with ReadSpeaker docReader to view resources that can assist you in creating some of these types of deliverables.
Identify which case study you chose.
Apply the “Six Essential Elements of a Transfer Support Process” to this case (see p. 177 – 186 in your The Six Disciplines of Breakthrough Learning text).
How effective are these six elements in this case?
If your case does not identify one of the six elements, state that this element was not identified.
And then propose a possible answer (what kind of information would make sense here?).
Using this same case study, refer to Table D5.1 “Common Kinds of Performance Support and Their Uses” (p. 200 in your The Six Disciplines of Breakthrough Learning text).
Identify and describe at least 3 examples of performance support that you see in your case.
How effective do you think these performance supports are in your case? Why?
Approx length: Paper = 2 OR MOREpages, not including the title page or References page.

1). Describe your research questions and why you are interested in the chosen topic.
2). Describe your biggest challenge in approaching your research topic. What areas gave you the hardest time?
3). If you were to implement your research study, what challenges do you foresee during the process?
4). Describe at least three (3) things you learned about your topic while preparing the research project proposal.

I would like to right 2 pages research proposal thesis master the topic is to examine foreign aid or humanitarian works of UAE or from UAE to South America
Option to select two countries and compare.
Or option to do review for the past decade
This proposal is be for initial approval by email. The proposal should have but not limited to the following
Research title:
Research problem:
Research question or goal.
Methodology

Directions Research two buildings using two different materials as their primary material choice (concrete, wood, steel, masonry)—other than your discussion choice. Create a PowerPoint presentation to include at least two images of each project, a description of the material chosen, and your opinion as to why this particular material was chosen. Include at least one graphic image example (or a hand sketch) of a construction detail of this material. Also, address the advantages and disadvantages of the material chosen and if you would have selected the same material in a side-by-side chart or analysis. Cleanly organize your work. Include a cover slide, a table of contents slide, and a references slide at the end. Include figure captions for included imagery. SCORING GUIDE (55 POINTS) Rating Scale 11-10 Work meets or exceeds criterion at a high level of competence. 9 Work reflects an understanding of the criterion with minor misunderstandings/misconceptions. 8 The criteria were partially met, but one or more important concepts/skills must be added or corrected. 7 Work reflects an attempt to meet the criterion, but significant misunderstandings/misconceptions are apparent. 6-0 Criterion needs to be met, or work is absent. Criteria 1. Research two buildings using two materials as their primary material choice: (concrete, wood, steel, and masonry). 2. Create a PowerPoint presentation that includes at least two images of each project and a description of the material chosen. 3. The presentation includes the student’s opinion as to why this particular material was chosen. 4. The presentation addresses the advantages and disadvantages of the material chosen and whether the students would have selected the same material. 5. Follows current APA research, writing, sourcing, and citing guidelines.

Research a building or architecture/construction project online that involves the use of one of the following construction materials uniquely or impressively: concrete, masonry, wood, or steel. Include a summary of notes on the use of the material, construction details, or other points of interest relating to the material application and construction. Note: Include your interest in working with the material in the industry. Include a website link to the project case study to share with your classmates and instructor. Cite your source in APA format. I will add two peer posts to reply to after the initial discussion has been posted.