Permission is granted
to
download, photocopy, and use copies of these exercises in a training
class within your own organization. It is prohibited, however, to
transmit, reprint, or distribute the exercise(s) for commercial sale
or during a nonprofit or commercial course or conference.
Background
In documentation classes, after providing
participants
with an overview of basic good documentation practices, use an exercise
to
help reinforce your points. Go over the answers together after
everyone has had a chance to "look for the errors."
Prior to class, make enough photocopies of the
exercise
for each course participant. (We like to use colored paper; a
different color for the Manufacturing exercise and a different color
for the Laboratory exercise.) Ask class participants to find the
errors, circling them on each page. Once they have had a chance
to look through both exercises, ask them to team up with their neighbor
to discuss the errors they found. Ask them to look for "sneaky"
problems, such as the use of felt-tip pen, not
initialling and dating each change, and so on. Explain to them
that
each entry is a separate item -- no. 1 is different from no. 2, no. 2
is
different from no. 3, and so on (each sheet contains multiple, separate
items
and is not supposed to represent a single batch record page or lab
notebook
page.) If you wish, modify or redo the exercises to use your
company
or product terminology before copying them.
After the team discussion, go over the results with
the
entire class. Ask "what's wrong with number one?" and have them
respond. Continue until all entries are discussed. Class
participants love to
find errors. Sometimes they can find errors that you did not know
were
there. When you teach, whenever you can, include interactive
activities,
exercises, and case studies for adults to learn from each other.
Use Information
The information on the pages linked above is provided free-of-charge
for
downloading, photocopying, and using in your classes or department
meetings.
The reprinting, transmission, or distribution for sale or use in a
for-fee
conference or course of this information is expressly prohibited.
The
Immel Resources LLC copyright statement should remain on the base of
each
exercise.
Disclaimer
This information is not all-inclusive nor is it intended to replace the
advice
of an experienced quality assurance or regulatory compliance
professional.
Every organization manufacturing pharmaceutical, biological, and
medical
device products must meet at least the minimum, applicable current good
manufacturing
practices (CGMPs).
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