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ADHE 329 Assignment 1

Analyze the Planning Context and Learner Community

Carmen Cheung


Submitted to Dr. Smulders on Sep25, 2011

Comment [DS1]: lor subsequenL
asslgnmenLs could you please add your
program LlLle here?

rogram roposa|
our ldea and Lhe raLlonale behlnd lL look very sound and are well explalned and
[usLlfled 1he only Lhlng l can'L flgure ouL ls how much Lralnlng ls lnvolved here
boLh levels of Lralnlng a revlslon of exlsLlng mandaLory Lralnlng or someLhlng
compleLely new
lor formaL you've explalned Lhls well excepL LhaL lL's noL clear lf Lhe Lralnlng ls a
Lwo/fourhour block of Llme or wheLher parLlclpanLs can Lake Lhls as Lwo hours over
a longer perlod of Llme
l've posed some quesLlons abouL Lhe conLexL for you lncludlng Lhe culLure of
learnlng Lhe mandaLory naLure of Lhe program Lhe proposal or developmenL

Learner Commun|ty
lL would be helpful Lo deLermlne wheLher learners wlll be parLlclpaLlng as a group or
on an lndlvldual self sLudy basls glven Lhe formaL you are proposlng

kef|ect|on and Ins|ghts
very good observaLlons ln your flnal paragraph keep Lhese ln mlnd

Well wrlLLen and organlzed



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

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
Comment [DS8]: es a very key polnL
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.