Post- Approval Changes: Ensuring Compliance and Efficiency
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 elements incorporated in Post- Approval Change Process: Compliance and Efficiency. Refer to the course agenda on pages 4 and 5 for additional examples.
Exercise 6: Case Study Focusing on Correct/Incorrect Implementation of SUPAC-SS
Participants will divide into groups and each group will be assigned one of the two examples:
-
Change in the particle size distribution of a primary drug substance
-
Change ABC preservative to XYZ preservative and reduce the amount used by 25%
Each group will determine:
-
Level of change
-
How it would be submitted
-
Required testing
-
Required documentation
Booking Options
This course is available exclusively as an onsite training solution. To discuss a solution that fits your organization's needs, objectives, schedule and budget, contact a PTi Client Solutions Manager at 800-303-8194 or OnSiteSolutions@pti-international.com.