Real World Approaches to PAT and QbD Implementation
October 20 - 21, 2009
Frankfurt, Germany
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This course is available as a client site course. Please click here for more information.
Who Should Attend
This course provides advanced concepts and case studies
aimed at ensuring success in operating a PAT manufacturing
program or QbD new-drug development effort. It will benefit
professionals who are involved in the development, testing and
production of pharmaceuticals, both small-molecule and biologic,
as well as those who manage and regulate them, including:
• PAT and QbD Team Members
• Product planners and risk managers
• Formulation and scale-up personnel
• Unit operations personnel
• Instrumental analysts
• Manufacturing Operations personnel
• Development-to-market product team members
• In-process and release testing personnel
• Industrial Pharmacists
• Managers tasked with improving the pharmaceutical
business climate
Description
PAT, an efficient approach to manufacturing and testing
regulated drugs, grew from a perceived regulatory risk into
an effective approach for improved drug product consistency
and positive time-on-market product life. QbD focuses on
development of new drugs – from the molecular concept
through acceptable patient use. The course links the principles
and practices of successful PAT & QbD into templates for
product “goodness” and consistency across the entire life
cycle.
This course, a second-generation program is designed to ensure
better assurance of successful outcomes. Its “how-to” content
includes thorough grounding in the use of risk management
and process-understanding tools and case studies for concept
demonstration. Participants will gain cross-platform information
on ICH Q8, Q9 and Q10 applications, effective use of
classification tools, team structure and management, especially
in technology transfer aspects.