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ADHE 329 Assignment 1

Analyze the Planning Context and Learner Community

Carmen Cheung

This is an analysis of the process of creating a Good Manufacturing Practices (GMP) training course designed for a logistics company. The analysis consists of three parts Program Proposal, Organizational Context, and Analysis of the Learner community, and ends with a conclusion.

A) Program Proposal Summary of Training Content This is a proposal for a Good Manufacturing Practices (GMP) training course designed for a third party logistics company. This company provides contracted services for the storage and distribution of pharmaceutical products. It is a small-sized company with around twenty-five employees, which include un-unionized management team and unionized warehouse and customer service staff. All employees and contractors are required to be trained on GMP. However, the management team needs to attain an advanced level of GMP understanding. Because of this, two levels of the GMP course need to be developed. The function of GMP guidelines is to ensure lot traceability in the event of a recall situation, to avoid product mix-ups, to avoid product adulteration (ex. reduction in product efficacy as a result of incorrect product storage). The logistics company must follow these guidelines in order to meet the Food and Drug Act and federal regulations for finished pharmaceutical products and to ensure product safety and efficacy (identity, potency, and purity). All staffs need to be aware of how the principles of GMP will affect their area of work. According to GMP Guidelines, training is provided prior to implementation of new or revised standard operating procedures, records of training are maintained, and the effectiveness of continuing training is periodically assessed. (Canada, p16) New staff needs to receive initial training, and on-going training is required for existing staff periodically as defined in the companys established procedures. Presenting the GMP training course on an online Learning Management System (LMS), such as Moodle, will be able to satisfy all these requirements. Format 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 of resources needed to train employees, such as time and money. In addition, the LMS allows for standardized training which can increase the efficacy of the training itself and allow for tracking of training due dates. Digital records of training for each employee are maintained on the LMS. The first level GMP training course for the unionized team will be two hours long, and the second level GMP course for the management team will be four hours long. A multiple choice quiz will be administered at the end of 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 manufacturers and wholesalers) and retain existing ones, and to improve the overall company bottom line. Since the sponsoring organization is a stand-alone company, all courses and processes that are developed for the LMS are solely proprietary to the company itself. Stakeholders and Responsibilities I am a consultant employed by the sponsoring organization to develop and implement an LMS for 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 qualified personnel having regard to the function and in accordance with a written program for all personnel involved in the fabrication of the drug, including technical maintenance and cleaning personnel. (Canada, p16) Since the QA is the qualified person the QA has the overall responsibility of the set up and development of the LMS in order to assure the training program is within regulatory guidelines. The QA and the consultant are responsible for 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 of time due to a major observation cited during a recent audit. However, there are financial constraints in the course development. Most of the budget will be assigned to the set up and validation costs of the LMS. The rest of the budget will be used for 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 of GMP courses involved. Since the management team is ultimately responsible for the decision making process that will impact product safety and efficacy, they need to have a more thorough understanding of GMP in comparison to the unionized staff. The employees are activity-oriented and goal-oriented, according to Houles three types of 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 successful completion of the GMP course. It is

expected that most, but not all of the learners will be learning-oriented and learn about the material because of their innate desire to know.

Potential Barriers to Learning According to Cross, there are three potential barriers to learning for adult learners situational, institutional, and dispositional. Since the training is offered to the employees at no cost, the potential situational barrier is minimal. Institutional barrier is also minimal since staff 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 dont think they are capable of learning new material. The course planner can make help accessible to all learners, but it could be difficult to change the learners attitude towards learning. Since this program is designed to be self-studied, learners might feel isolated at times. Providing channels for building a community of learners in the company would help provide more support and motivation.

D) Conclusion

Ive had experience creating course materials for the K-12 system, but never created any courses for the corporate world. Through the completion of this initial analysis, I learned that unlike working for 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 before building a course for a company. For instance, the creator needs to consider the structure and culture of the company, different roles and responsibilities of the stakeholders in the training process, and the mode and duration of 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 for K-12 students and for adult is that we need to understand our learners needs. From ADHE 329, I learned about Houles three types of motivation and Crosss three barriers to efficient learning which helped me understand more about adult learners. I am excited to learn more about course planning for adult learners in upcoming lessons.

References Caffarella, 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, Version 2, Document GUI-0001. Health Canada, 04 Mar. 2011. Web. 23 Sept. 2011. <http://www.hc-sc.gc.ca/dhp-mps/alt_formats/pdf/compli-conform/gmp-bpf/docs/gui-0001eng.pdf>.