Complying with FDA/ICH Requirements for Stability Testing
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 Complying with FDA/ICH Requirements for Stability Testing. Refer to the course agenda on pages 4 and 5 for additional examples.
Module 7: Test Method Validation
Participants split into three groups. Each group is given a hypothetical scenario, reviews the assigned scenario and answers the questions provided. At the conclusion of the exercise, each group reports findings to the class. Below is one of the three hypothetical scenarios:
You work for XYZ Pharma Labs and the Development Chemist just informed you that they changed the solvent used in the final crystalization process.
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What would you do?
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What validation characteristics would you re-evaluate? And why?
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.