First Principles to Improve Pharma Manufacturing Operations Training Course

Level: Fundamental and Intermediate
ISPE CEUs: 1.3
Type: Classroom Training Course

Efficient, Effective Pharma Manufacturing Problem Solving Through the Use of Engineering First Principles (T60)

Overview

The implementation of Quality by Design (QbD) and Six Sigma within the pharmaceutical industry has led to an emphasis on the importance of companies developing a robust operational control strategy (OCS) to drive the management of product manufacturing processes. This course will show how First Principles-based approaches will provide a valuable tool to help create such control strategies. Drawing on examples from over 30 years’ experience in the pharma industry, the attendees will see what First Principles are and how not using a First Principle approach can lead to poor problem solving and even significant disasters. Many activities and exercises will be used to demonstrate the application of First Principles to problem-solving in pharmaceutical manufacturing and engineering. A detailed process for implementing the First Principle approach will be presented, including an example of a complete application of this process.

At the completion of this course, attendees will understand how to identify areas of opportunity for applying the First Principle approach and how to present the results and benefits from such an approach. Many of the First Principle applications presented during the course will be made available to the attendees in macro driven Microsoft Excel files that can be used to review the examples and discuss with colleagues within their own organizations. Attendees are encouraged to bring a laptop with Microsoft Excel to gain maximum benefit from this course.

Course Modules

  • The Case for First Principles
  • What are First Principles?
  • Planning
  • Create
  • Confirm and Implement
  • Application of First Principles in areas relevant to pharma
  • Application of the entire First Principle process
  • Broader Application of First Principles

Take Back to Your Job

  • Understand and discuss the value of using a First Principle approach to manage systems, creating control strategies and solving problems.
  • Describe what First Principles are (and are not!) in both a mathematical and non-mathematical way.
  • Create and explain a detailed process for implementing a First Principle based approach to problem-solving and managing systems.
  • Distinguish when to use the First Principles based approach and where it should be avoided.
  • Analyze and communicate the outcome of using the First Principle approach to manage systems and solve problems.
  • Understand the role of modeling tools and know what portfolio of tools to use when the First Principles application involves significant computational complexity.
  • Demonstrate the ability to apply First Principle based approaches involving both manufacturing and non-manufacturing processes.

Attendance Suggested For

Engineers in the pharmaceutical industry who are interested in understanding how to apply First Principles-based analysis to improve their problem solving within manufacturing, engineering, and process development. It may also be of interest to scientists that support pharmaceutical manufacturing who would like to know more about how analyses based on Engineering First Principles can be used to support the implementation of Quality by Design (QbD).

This course is not currently scheduled, but may be offered at your company site. Please contact ISPE for more information