Implementing Process Analytical Technology
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ISPE CEUs*: 1.5 |
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Date |
Location |
Country |
Instructor(s) |
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24-25 September 2008 |
New Jersey Classroom Training Series |
United States |
Joydeep Ganguly |
Description
Process analytical technology (PAT) is the wave of the future for the pharmaceutical industry. As defined by the FDA, PAT is “a system for designing, analyzing, and controlling manufacturing through timely measurements (i.e., during processing) of critical quality and performance attributes of raw and in-process materials and processes with the goal of ensuring final product quality.” As a scientific, risk-based framework, PAT is intended to support innovation and efficiency in pharmaceutical development, manufacturing, and quality assurance. The framework is founded on process understanding to facilitate innovation and risk-based regulatory decisions by industry and the Agency.
This course is designed to help pharmaceutical manufacturing professionals chart a new course for innovation based on PAT. The course provides an overview to the tools and principles outlined in the new FDA guidance, PAT - A Framework for Innovative Pharmaceutical Development, Manufacturing and Quality Assurance. Concepts to help organizations meet regulatory requirements for validating and controlling the manufacturing process also are provided.
Take Back to Your Job
- Explain the PAT framework and its concepts of process understanding and process control
- Understand the PAT tools and principles and how to apply them in their own organizations
- Describe the regulatory processes open to firms who embrace the PAT framework
Attendance Suggested For
- Professional engineers and managers involved in pharmaceutical drug product manufacturing and development, quality assurance, and regulatory affairs
- Facilities engineering and validation/commissioning service providers
ISPE will provide continuing education units (ISPE CEUs) for all North American seminars and courses, including educational programming at the ISPE Annual Meeting. CEUs are nationally recognized units of achievement designed for those individuals continuing their education in their chosen field or profession.
Delegates attending European seminars and courses will receive a Certificate of Attendance, as ISPE CEUs are currently not offered at European events. Verification of CEUs is based on attendance as well as satisfactory completion of all evaluation materials. Statements of credit will be mailed within four weeks of evaluation materials. One hour of education programming equals 0.1 ISPE CEU credits.