Implementing Process Analytical Technology (T29)

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Training

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

Date	Location	Country	Instructor(s)
This course is not currently scheduled, but may be conducted at your company. 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 sent via email within four weeks of evaluation materials. One hour of education programming equals 0.1 ISPE CEU credits.

Last Update: 13 February 2013