Qualstar Simulation: CGMP or QSR an Advanced Course
To reinforce the importance of documentation, procedures, change control and QA.
About the Class
2. Orientation to the class
3. Writing, formatting and guidelines
4. Revisions and approval
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
1. Regulatory requirements
2. Common industry practices
3. Highlights of your change control process
and Their Role in Documentation
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 | firstname.lastname@example.org | Fax: 954.566.5225
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