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Aseptic Processing of Sterile Drug Products

Strategies for Ensuring Regulatory Compliance

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

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 Aseptic Processing of Sterile Drug Products.  Refer to the course agenda on pages 4 and 5 for additional examples.

Exercise: "Analyze Examples of Simulation Runs" 

  • The FDA is visiting your facility and is reviewing your process simulation fills.  As they "peel the onion," they have requested that you provide data on your media fills to include justification for the size of the fill
  • Discuss the factors that would be used to justify the number chosen or the method used to simulate normal extended production runs

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

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