PTI - international

Interactive Elements

Adults and professionals learn better when the classroom is a vibrant, stimulating place. That's why we incorporate discussions, exercises and quizzes into all of our courses. These activities reinforce training and foster a practical, hands-on educational experience.

The following is one of several interactive exercises included in Complying with cGMP and GMP Requirements – Advanced Level. Refer to the course agenda on pages 4 and 5 for additional examples.

Part 11 Compliance Scenario

1. Divide into two teams
2. Review the assigned "real life" scenario
3. Determine the predicate rules that apply to the scenario
4. Determine if Part 11 compliance is necessary and the reasoning why/why not
5. Determine validation and audit trail needs
6. Appoint a spokesperson to address your group's findings
7. Be prepared to share your responses during a large group debrief facilitated by the instructor