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.


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. 

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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