766 Alignment

Valli Chidambaram

Project Description
Pharmaceutical and Clinical Research Organizations are subject to Federal regulatory body inspections and
audit because of their sensitive nature of work. These companies have to follow strict documentation and
training guidelines as part of good manufacturing practice (GMP).Conformance to regulatory body
guidelines is only possible by effective training of employees. This project describes a training approach for
employees which is immersive and mimics a real life business process. Objective is to familiarize them
with the adopted standard operating procedures (SOP) and work instructions (WI) documented for their
business process. For example, in the IT department for a Pharmaceutical company, there is testing group
which creates methods for testing of business process software. The testing should be based on guidelines
as outlined in the Standard Operating Procedure (SOP). If the SOP is not followed, company is not in
adherence to the regulatory requirements.

Delivery Method
The training will be delivered online due to flexibility in delivery, cost and minimal interruption of daily
work.
Terminal Objective: Upon completion of the SOP Training, learner must be able to determine the Overall
Testing Strategy for testing of the Computerized system in pharmaceutical business process.
Enabling Objectives
Assessment Idea
Absorb Activity
Do Activity
Connect Activity
Learner must be able
Learners will be
Presentation Slide Quiz questions
Job aid.
to describe the process presented with a
Show describing
flow for testing of
quiz that will require the overview and
computerized system
learners to drag and process flow
drop the answers in
correct sequence for

Learner must
document the test
strategy and test plan
for testing of
computerized system.

Obtain appropriate
reviewer, approver
signatures for test
strategy and plan.

accurately
describing the
process flow.
Text entry quiz to
test the learners
knowledge of the
different documents
for the process.

Reading material
Reading about
the different
documents to be
produced for
testing of
computerized
system
Learners will be
Reading about the
asked to identify the various signatures
correct relationship
and approvals
between items and
required for test
the appropriate
strategy plan.
signatories.

Quiz questions

Job aid(Step by
Step work
instructions)

Match the
following type
Quiz questions

Ponder Activity
Learner will be
provided with a
sample document
to demonstrate the
ability to get the
signatures in the
correct sequence

Terminal Objective: Upon completion of the SOP Training, learner must be able to follow the steps for
Manual System Test
Enabling Objectives Assessment Idea
Absorb Activity
Do Activity
Connect Activity
Develop Manual
Learner will be
Reading material
Quiz questions
Job aid(Step by
System Test Script
presented with
for development
Step work
and execution of
instructions)
Execute the Manual single/multiple
answer questions
manual system test
System Test Script
and asked to make scripts.
choices from
Video

Obtain appropriate
reviewer, approver
signatures for test
scripts.

predetermined list.
Learners will be
asked to identify
the correct
relationship
between items and
the appropriate
signatories

demonstration
Reading about the
various signatures
and approvals
required for test
script document.

Terminal Objective: Upon completion of the SOP Training, learner

Acceptance Test
Enabling Objectives Assessment Idea
Absorb Activity
Develop User
Learner will be
Reading material
Acceptance Test
presented with
for development
Script
single/multiple
and execution of
answer questions
user acceptance
Execute the User
and asked to make test scripts.
Acceptance Test
choices from
Video
Script
predetermined list. demonstration
Obtain appropriate
Learners will be
Reading about the
reviewer, approver
asked to identify
various signatures
signatures for test
the correct
and approvals
scripts.
relationship
required for test
between items and script document.
the appropriate
signatories

Match the following

type Quiz questions

Ponder Activity
Learner will be
provided with a
sample document
to demonstrate the
ability to get the
signatures in the
correct sequence

must be able to follow the steps for User

Do Activity
Quiz questions

Connect Activity
Job aid(Step by
Step work
instructions)

Match the following

type Quiz questions

Ponder Activity
Learner will be
provided with a
sample document
to demonstrate the
ability to get the
signatures in the
correct sequence

Terminal Objective: Upon completion of the SOP Training, learner

the final Documentation for Testing of the Computerized system.
Enabling Objectives Assessment Idea
Absorb Activity
Document Defect
Multiple Choice
Reading material
log and Minor issue questions
which comprises
log
True/False
documentation on
Questions
defect log, minor
Document the Test
Fill in the blanks
issue log, and test
Summary Report
quiz
summary report
creation.
Video
demonstration
Learners will be
Reading about the
Obtain appropriate
asked to identify
various signatures
reviewer, approver
the correct
and approvals
signatures for
relationship
required for testing
executed test
between items and documents.
scripts, results and the appropriate
Summary report.
signatories
Submit the
Summary Report to
Quality
Assurance(QA)

Quiz questions

Narration

must be able to assemble and complete

Do Activity
Mastery Quiz

Connect Activity
Job aid(Step by
Step work
instructions)

Match the following

type Quiz questions

Ponder Activity
Learner will be
provided with a
sample document
to demonstrate the
ability to get the
signatures in the
correct sequence