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This document analyzes the process of creating a Good Manufacturing Practices (GMP) training course for a logistics company. It consists of three parts: 1) A proposal for a two-tier GMP training program, with a 2 hour course for staff and 4 hour course for management. 2) An analysis of the organizational context, including goals, stakeholders, and limitations. 3) An examination of the learner community, identifying their backgrounds, motivations, and potential barriers to learning. The analysis concludes by reflecting on lessons learned about designing corporate training compared to K-12 education.
This document analyzes the process of creating a Good Manufacturing Practices (GMP) training course for a logistics company. It consists of three parts: 1) A proposal for a two-tier GMP training program, with a 2 hour course for staff and 4 hour course for management. 2) An analysis of the organizational context, including goals, stakeholders, and limitations. 3) An examination of the learner community, identifying their backgrounds, motivations, and potential barriers to learning. The analysis concludes by reflecting on lessons learned about designing corporate training compared to K-12 education.
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This document analyzes the process of creating a Good Manufacturing Practices (GMP) training course for a logistics company. It consists of three parts: 1) A proposal for a two-tier GMP training program, with a 2 hour course for staff and 4 hour course for management. 2) An analysis of the organizational context, including goals, stakeholders, and limitations. 3) An examination of the learner community, identifying their backgrounds, motivations, and potential barriers to learning. The analysis concludes by reflecting on lessons learned about designing corporate training compared to K-12 education.
Авторское право:
Attribution Non-Commercial (BY-NC)
Доступные форматы
Скачайте в формате DOCX, PDF, TXT или читайте онлайн в Scribd
Analyze the Planning Context and Learner Community
Carmen Cheung
76471994
Submitted to Dr. Smulders on Sep25, 2011
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This is an analysis oI the process oI creating a Good ManuIacturing Practices (GMP) training course designed Ior a logistics company. The analysis consists oI three parts Program Proposal, Organizational Context, and Analysis oI the Learner community, and ends with a conclusion.
A) Program Proposal
Summary of Training Content
This is a proposal Ior a Good ManuIacturing Practices (GMP) training course designed Ior a third party logistics company. This company provides contracted services Ior the storage and distribution oI pharmaceutical products. It is a small-sized company with around twenty-Iive employees, which include un-unionized management team and unionized warehouse and customer service staII. All employees and contractors are required to be trained on GMP. However, the management team needs to attain an advanced level oI GMP understanding. Because oI this, two levels oI the GMP course need to be developed.
The Iunction oI GMP guidelines is to ensure lot traceability in the event oI a recall situation, to avoid product mix-ups, to avoid product adulteration (ex. reduction in product eIIicacy as a result oI incorrect product storage). The logistics company must Iollow these guidelines in order to meet the Food and Drug Act and Iederal regulations Ior Iinished pharmaceutical products and to ensure product saIety and eIIicacy (identity, potency, and purity).
All staIIs need to be aware oI how the principles oI GMP will aIIect their area oI work. According to GMP Guidelines, 'training is provided prior to implementation oI new or revised standard operating procedures, 'records oI training are maintained, and 'the eIIectiveness oI continuing training is periodically assessed. (Canada, p16) New staII needs to receive initial training, and on-going training is required Ior existing staII periodically as deIined in the company`s established procedures. Presenting the GMP training course on an online Learning Management System (LMS), such as Moodle, will be able to satisIy all these requirements.
ormat and Duration of Training
Since the training is online, the trainers are not required to provide training on an individual basis. This can substantially minimize the amount oI resources needed to train employees, such as time and money. In addition, the LMS allows Ior standardized training which can increase the eIIicacy oI the training itselI and allow Ior tracking oI training due dates. Digital records oI training Ior each employee are maintained on the LMS.
The Iirst level GMP training course Ior the unionized team will be two hours long, and the second level GMP course Ior the management team will be Iour hours long. A multiple choice quiz will be administered at the end oI the training, in which the trainees will be required to obtain 100 on the course in order to pass.
B) Analyze the Organizational Context
Organization Context
The organization has multiple goals, which include being compliant with current regulations, able to attract new clients (pharmaceutical manuIacturers and wholesalers) and retain existing ones, and to improve the overall company bottom line. Since the sponsoring Comment [DS2]: kay Lhls ls good ou've provlded some loglcal groundlng for Lhls need Comment [DS3]: lL would be good Lo know lf Lhe LMS ls already ln use for Lhese purposes or lf Lhe course wlll be lnlLlaLlng some of Lhls Lype of Lracklng organization is a stand-alone company, all courses and processes that are developed Ior the LMS are solely proprietary to the company itselI.
Stakeholders and Responsibilities
I am a consultant employed by the sponsoring organization to develop and implement an LMS Ior their GMP training. Course content will be developed jointly by operations manager, customer service manager, and the QA. They are the content experts. According to the GMP Guideline, 'training is provided by qualiIied personnel having regard to the Iunction and in accordance with a written program Ior all personnel involved in the Iabrication oI the drug, including technical maintenance and cleaning personnel. (Canada, p16) Since the QA is the qualiIied person the QA has the overall responsibility oI the set up and development oI the LMS in order to assure the training program is within regulatory guidelines. The QA and the consultant are responsible Ior the planning process, and they are also the process experts.
Limitations in the Course Planning Process
The course needs to be delivered within a limited amount oI time due to a major observation cited during a recent audit. However, there are Iinancial constraints in the course development. Most oI the budget will be assigned to the set up and validation costs oI the LMS. The rest oI the budget will be used Ior maintaining the LMS.
C) The Learner Community
Learners` Background and Motive
We need to develop the GMP training in order to comply with the current regulations. There are two levels oI GMP courses involved. Since the management team is ultimately responsible Ior the decision making process that will impact product saIety and eIIicacy, they need to have a more thorough understanding oI GMP in comparison to the unionized staII.
The employees are 'activity-oriented and 'goal-oriented, according to Houle`s three types oI motivation. On one hand, the company needs to ensure that the employees complete the training in a timely manner so as to comply with current regulations. On the other hand, the employees can expect a pay increase upon successIul completion oI the GMP course. It is expected that most, but not all oI the learners will be 'learning-oriented and learn about the material because oI their innate desire to know.
Potential Barriers to Learning
According to Cross, there are three potential barriers to learning Ior adult learners situational, institutional, and dispositional. Since the training is oIIered to the employees at no cost, the potential 'situational barrier is minimal. 'Institutional barrier is also minimal Comment [DS4]: kay Comment [DS5]: l Lhlnk you are deslgnlng Lhls course wlLhouL an lnsLrucLor (lndependenL self sLudy) buL l'm noL sure l see Lhls expressed dlrecLly Comment [DS6]: ou should clLe your source when you lnclude Lerms LhaL lmply a more deLalled deflnlLlon (l know where you're geLLlng Lhls from buL lL's [usL good form Lo clLe ln cases llke Lhls) since staII is automatically assigned the GMP course by the LMS administrator (QA), which is easily accessible online without complex registration processes. However, there is a chance that the learner might have dispositional barrier, in which case they don`t think they are capable oI learning new material. The course planner can make help accessible to all learners, but it could be diIIicult to change the learners` attitude towards learning. Since this program is designed to be selI-studied, learners might Ieel isolated at times. Providing channels Ior building a community oI learners in the company would help provide more support and motivation.
) Conclusion
I`ve had experience creating course materials Ior the K-12 system, but never created any courses Ior the corporate world. Through the completion oI this initial analysis, I learned that unlike working Ior the public school system where teachers mainly plan out their own course schedule to teach the predetermined learning outcomes, many questions need to be addressed by the course creator beIore building a course Ior a company. For instance, the creator needs to consider the structure and culture oI the company, diIIerent roles and responsibilities oI the stakeholders in the training process, and the mode and duration oI delivery the training. In many cases, the content expert and the process expert might not be the same person/group, and communication between the two is crucial to the planning process.
One thing in common between designing a course Ior K-12 students and Ior adult is that we need to understand our learners` needs. From ADHE 329, I learned about Houle`s three types oI motivation and Cross`s three barriers to eIIicient learning which helped me understand more about adult learners. I am excited to learn more about course planning Ior adult learners in upcoming lessons.
Comment [DS7]: ased on your descrlpLlon of Lhls program lL seems Lhe maln barrler Lo learnlng wlll be dlsposlLlonal ln LhaL parLlclpanLs may only be lnLeresLed ln Llcklng Lhe boxes Lo clear Lhemselves of Lhe obllgaLlon Lo Lake Lhe course raLher Lhan belng commlLLed Lo acLually learnlng abouL Lhe sub[ecL maLLer ln quesLlon l Lhlnk Lhls wlll pose a challenge for you as Lhe course deslgner Comment [DS8]: es a very key polnL References CaIIarella, Rosemary S. Planning Programs for Adult Learners. a Practical Guide for Educators, Trainers, and Staff Developers. San Francisco: Jossey-Bass, 2002. Print. Canada. Health Canada. Good Manufacturing Practices (GMP) Guidelines 2009 Edition, Jersion 2, Document GUI-0001. Health Canada, 04 Mar. 2011. Web. 23 Sept. 2011. http://www.hc-sc.gc.ca/dhp-mps/altIormats/pdI/compli-conIorm/gmp-bpI/docs/gui-0001- eng.pdI~.