Qualstar Simulation
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Qualstar Simulation: CGMP or QSR an Advanced Course




To reinforce the importance of documentation, procedures, change control and QA.



  1. To demonstrate proper documentation practices.

  2. To experience the value of well-written procedures.

  3. To demonstrate proper actions when procedures contain errors.

  4. To experience the value of the quality unit.

About the Class

  1. In-house projects will be used to demonstrate and practice the skills and principles of this class.

  2. The optional final exam is approximately 25 questions.

  3. Each student receives a student guide containing a representation of the program's  slides and graphics with space provided for note taking.

  4. This class can accommodate up to 25 people.

  5. Duration: 8 hours as a minimum. Depending on the project selected, this class may take several days.




1.    Welcome

2.    Orientation to the class

Standard Operating Procedures

1.     QA responsibility

2.     Uses of procedures

3.     Writing, formatting and guidelines

4.     Revisions and approval

5.     Review frequency

6.      Activity: Write a Procedure with Auditing



1.     Proper Documentation Practices

2.     483 Observations relating to documentation

3.     Predicate rule documents

4.     Activity: CGMP Challenge: Documentation

 Change Control

1.     Regulatory requirements

2.     Common industry practices

3.     Highlights of your change control process

 QA and Their Role in Documentation

1.     Review

2.     Approve

3.     Reject


 Activity: Qualstar Simulation

1.     Instructions

2.     Simulation

3.     Debrief

4.     In this simulation the class is divided into teams of three. In their teams they are to build a simple project following procedures, completing required documentation, and appropriate CGMP required activities. While the teams are working on their projects the instructor serves two roles, one role is quality assurance for each the team, and the other role is that of the inspector. Teams are competing to sell their project to the "customer". Quality, compliance, and timeliness are all critical strategies that must be managed in order for a team to succeed.



Call to learn about how we can customize this outline for any of your site's CGMP training needs. Standard outlines may change without notice. To speak with the lead instructor for this class please call Allan Dewes at 415.948.5220.


For a prompt reply to requests and questions:  415.948.5220 |  skillsplus@aol.com    |   Fax: 954.566.5225

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