Statistical Process Control for the Biopharmaceutical Industry Course Outline

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Who Should Attend: This course is designed for anyone who works in the biopharmaceutical industry. Although it is useful for the “troops in the trenches” who will carry out the actual SPC calculations, it is intended also for their supervisors all the way up the company structure who must understand the material to make proper managerial decisions, especially when improvements in processes are required.

Click on the titles below to learn more about each session. When live sessions are available, sign up anytime for the 8-session live course in February 2024! You will receive invitations to join upcoming live sessions. Or sign up to receive links to recordings of any or all sessions as soon as they are available.

Although designed to be taken in a series, you may pick and choose individual sessions, as they are designed to be stand-alone units. When you are ready, click on the “Register Now” button to sign up for individual sessions or the full course. Each live session is interactive: Login, listen, learn and ask questions!

Session 1 is FREE! Each 60-minute session is just $339 per session or $2373 for all eight sessions! Great group discounts are available.

Click the button below to watch the FREE recording of Session 1: Measurement!

Free SPC Session 1 Recording

Session 1: Measurement

Measurement

  • Instructor: Dr. Stanley Deming
  • Format: On-demand recording available now.
  • Content:
    ● A measurement process is a production process that produces numbers
    ● Some definitions and an opinion
    ● A stable process that is in statistical control
    ● An unstable process that is not in statistical control
    ● The relationship between a measurement process and a manufacturing process
    ● Don’t mistake instability in a measurement process for instability in a manufacturing process
    ● Accuracy and precision
    ● A question of truth
    ● Apply SPC to measurement processes first, then to manufacturing processes

Session 2: Relevant Concepts in Statistics

Relevant Concepts in Statistics

  • Instructor: Dr. Stanley Deming
  • Format: On-demand recording available April 2024.
  • Content:
    ● Gaussian distributions: the mean and standard deviation
    ● Degrees of freedom
    ● z-values, a unifying tool for looking at Gaussian distributions
    ● Areas under Gaussian distributions and their interpretation in the real world
    ● Homoscedasticity
    ● Heteroscedasticity
    ● The Horwitz curve
    ● Big n tames statistics
    ● The central limit theorem as a rationalization for using Gaussian statistics in SPC

Session 3: Process Capability

Process Capability

  • Instructor: Dr. Stanley Deming
  • Format: On-demand recording available April 2024.
  • Content:
    ● The voice of the process
    ● The voice of the customer
    ● Defining standardized specification limits
    ● To be capable, the voice of the process and the voice of the customer must agree
    ● Specified tolerance
    ● Process capability ratio Cp
    ● Centered process capability ratio Cpk
    ● Six-sigma quality
    ● Biopharmaceutical reality

Session 4: Control Charts

Control Charts

  • Instructor: Dr. Stanley Deming
  • Format: On-demand recording available April 2024.
  • Content:
    ● X-bar and R charts
    ● Control chart paper
    ● Make control charts by hand first, then become familiar with and use reliable software
    ● How to construct control charts
    ● Calculating control limits
    ● Do not use control limits for specification limits
    ● Don’t continually recalculate control limits
    ● Recalculate control limits when a change has been made to the process
    ● Other types of control charts

Session 5: Lack of Control

Lack of Control

  • Instructor: Dr. Stanley Deming
  • Format: On-demand recording available April 2024.
  • Content:
    ● The “three-sigma” rule
    ● The “run-of-eight” rule
    ● Extracting additional information from control charts
    ● Don’t use popular “caution alarms” and “warning alarms”and their variants
    ● Don’t use too many rules for detecting lack-of-control situations

Session 6: Extremes of Control

Extremes of Control

  • Instructor: Dr. Stanley Deming
  • Format: On-demand recording available April 2024.
  • Content:
    ● The difference between “within specifications” and “in statistical control”
    ● The ideal state
    ● Threshold state A
    ● Threshold state B
    ● The “brink of chaos”
    ● The “state of chaos”
    ● The role of management for improving the state of statistical control
    ● A caution about the effects of entropy creeping into processes

Session 7: Measurement Redux

Measurement Redux

  • Instructor: Dr. Stanley Deming
  • Format: On-demand recording available April 2024.
  • Content:
    ● Review
    ● The ideal world
    ● The real world
    ● When the measurement process distorts the view of the manufacturing process
    ● “You can improve the apparent process capability by cleaning up the measurement process.”
    ● A workable relationship between the measurement variation and the process variation
    ● Biopharmaceutical reality

Session 8: Going Forward

Going Forward

  • Instructor: Dr. Stanley Deming
  • Format: On-demand recording available April 2024.
  • Content:
    ● An overview of SPC
    ● Learning from SPC is passive
    ● Learning from designed experiments is active
    ● An overview of research
    ● An overview of the statistical design of experiments

COPYRIGHT: U.S. Copyright Law protects the program you are about to attend from unauthorized duplication. Multiple participants are not authorized to share access provided to a single registrant.  For each individual who attends, a single dedicated seat license must be purchased, or a group rate must have been previously arranged with FasTrain. FasTrain reserves the right, at its discretion, to cancel or interrupt access to a web-based training class without notice, or to invoice and collect the group rate payment for the class from the single registrant if this requirement has been violated.