First Principles to Improve Pharma Manufacturing Operations Online Live Training

ISPE Learning Solution - Online Live Training Online Live


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 online live training 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.

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What You Will Learn

  • 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.

Resources and Activities

  • Pre-Course Work Materials
  • Interactive Exercises
  • Learning Assessments

Online Live Course Modules

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

Who Should Attend

  • 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).

Online Live Course Additional Details

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.

Daily Schedule and Pricing

  • Online Live
    21 - 22 July

    Daily Schedule at a Glance

    Day 1
    0900 – 0915 Login & Registration
    0915 - 0930 Introductions
    0930 - 1045 Course Content & Exercise
    1045 - 1100 Break
    1100 - 1215 Course Content & Exercise
    1215 - 1245 Lunch
    1245 - 1430 Course Content & Exercise
    1430 - 1445 Break
    1445 - 1615 Course Content & Exercise
    1615 - 1630 Questions & Discussions
    All times for this training course date are displayed in EDT.
    Day 2
    0900 Login
    0915 - 1030 Course Content & Exercise
    1030 - 1045 Break
    1045 - 1145 Course Content & Exercise
    1145 - 1200 Questions & Wrap-up
    All times for this training course date are displayed in EDT.

    Registration Fee


    On or Before 14 July 

    Member US$1,495 
    Nonmember US$1,695   
    Government/Academia US$550
    Student US$90

    On or After 15 July

    Member US$1,595   
    Nonmember   US$1,795   
    Government/Academia US$550
    Student US$98

    Mail or Fax Registration

    Not paying by credit card? Use the registration form to pay by mail or by fax.

    Now Your Whole Team Can Participate in an ISPE Online Live Learning Experience

    • 3 - 5 participants - Save 10%
    • 6 - or more participants - Save 20%

    Group discount applies to Member/Nonmember rate only. To qualify, all registrant information must be submitted at the same time. Registrations that arrive later will NOT be eligible for the group discount. Cannot be combined with other offers. To register as a group, please contact ISPE by telephone, +1-813-960-2105 or by email,


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