Olympics for Medical Devices
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Olympics for Medical Device Manufacturers




To take QSRs to a deeper level of understanding through a series of challenging activities



1.     List the hottest issues in QSR compliance.

2.     Locate items of interest in 21CFR820.

3.     Explain the 21CFR211 rationale for specific 483 observations.

4.     Demonstrate knowledge of common CGMP practices and details.

5.     State the consequences of not following QSR..


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 10-15 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: 4- 8 hours. Depending on the project selected, this class may take several days.



1.   Agenda

2.   Ground rules

3.   New issues and practices


Heard on the Street

1.   21 CFR 820

2.   Activity: Brainstorming questions about CGMP

3.   Open discussion   


Client directed presentation 

Time variable based on learning objectives


Inspection Detection

1.   Review 483 observation note

2.   Link observation to 21 CFR 820


CGMP Challenge

1.   Client selects 4 topics from a list of 18

2.   Questions are presented


Wrap Up

1.   Activity: Brainstorm important points to remember from the class

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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