Implementing Process Analytical Technology (T29)

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Level: Advanced
Type: Classroom Training Course
ISPE CEUs: 1.3

Date Location Country Instructor(s)
This course is not currently scheduled, but may be offered at your company site. Please contact ISPE for more information.

Description

Process analytical technology (PAT) is becoming a very important tool for controlling pharmaceutical processes and when implementing Quality by Design. As defined by the USFDA, 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 and is being seen as a very important tool for Quality by Design. The PAT 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 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.

Course Modules

  • PAT Vision and Framework
  • Consensus Standards
  • Implementing PAT
  • PAT in Development
  • PAT in Manufacturing
  • Risk Management
  • Multivariate Data Analysis
  • Design of Experiments
  • Process Analyzers
  • Process Control
  • Control Theory
  • PAT in Automation Control Systems
  • Introduction to Statistical Process Control (SPC)
  • Continuous Improvement
  • PAT related to Quality be Design
  • PAT related to Process Validation
  • Regulatory Approach

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 within your organization; how it can support the implementation of Quality by Design; and how it can be used for the new Process Validation approach
  • Describe the regulatory processes open to firms who embrace the PAT framework

Attendance Suggested For

  • Professional engineers, scientists and managers involved in pharmaceutical drug substance or drug product manufacturing and development, quality assurance, and regulatory affairs
  • Facilities engineering and validation/commissioning service providers

Community of Practice (COP)

This training course is of particular interest to existing and future members of the ISPE Process Analytical Technology Community of Practice (COP).

Continuing Education Units 

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 available for download in your ISPE account within four weeks of the completion of training. Instruction for download will be sent when the CEUs are available. One hour of education programming equals 0.1 ISPE CEU credits.

Last Update: 09 January 2014

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