Course offering number:0906-704
Course ID:
2305
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Key PAT Concepts: Focus on Desired State
In Conjunction with Wiley-Blackwell
Pre-recorded Course
AN ON-DEMAND ONLINE TRAINING FORMAT
Who Should Attend
This course is intended to help pharmaceutical industry professionals charged with enhancing and improving manufacturing efficiency for existing drug products by using Process Analytical Technology (PAT). Based on ICH documents, this course helps the user to establish a pathway to consistently high product quality. Desired State is a concept that extends drug product quality from unit operations through multi-plant venues to global life cycles. It is intended for:
• PAT & QbD team members and functional managers
• Quality program managers
• Regulatory affairs personnel
• In-process analysts
• Human Resource and Training staff
• Technology transfer personnel
• New product planners and developers
• Product financial planners
• Product release analysts
• Formulators
• Production managers
• Function cross-over personnel
• Operation personnel
Description
This 90-minute accredited training course helps users to reach the logical conclusion of PAT & QbD-oriented Design Space and Design of Experiment efforts. The course uses risk assessments, process benchmarking, and critical operation parameters to form a continual refinement plan. Combining experimental output, multivariate results and unit operation optimization, the course provides a framework for new product formulation, scale-up and release in a quality lifecycle format.
Module 1:
• Restoring the horse before the cart:
creating your drug manufacturing pattern
• Recursive operation and continual improvement
• Creating and using the RPN book
• The past is prologue: using data beyond batch history
Module 2:
• You desire the state: how do you know when
you get there?
• Does “good science” meet corporate needs?
• How should we measure optimization?
• Planning for parametric or real-time release
Module 3:
• Can you make it work at another site?
• Be sure to transfer failures as well as successes
• Factor patient needs and product use into
your developments
• Establish across-the-board agreement for valuing
the program
Question and Answer Session