Process Analytical Technology
- Location:
USA, CA, San Diego
- Start date:
2010-05-19
- Language:
English
- Price:
$1,795 US
- Last day to register: Three weeks before course start (2 days for Webinars).
- Conditions apply, see end of page
Detailed Description
Multivariate Analysis for PAT
This course introduces PAT (Process Analytical Technologies) as it applies in the pharmaceutical and biotech industries, and the objectives of PAT. This three-day course is dedicated to the multivariate methods and applications essential for development of process understanding and execution of PAT projects. The course covers PAT in both Process R&D and Manufacturing with the emphasis on chemometrics, analytical and IT aspects, and is illustrated by real life examples.
The topics covered include analysis of raw material variation, MV calibration, batch analysis and design of experiments. Applications include MV calibration, end point detection, multivariate monitoring (real-time MSPC) of batch processes, identification of critical process parameters, prediction of quality and a methodology for modeling complete production trains. There is also discussion of data infrastructure requirements that enable these types of analysis.
Chemometrics tools essential to PAT, i.e., PCA, PLS, Multivariate Calibration, Classification, Batch Modeling and Design of Experiments (DoE) are worked through and organized into the four levels of PAT.
The topics of data integration and IT, and the required infrastructure are addressed as well as Regulatory aspects.
After completing the course, each participant will be able to:
| • |
Identify critical process parameters |
| • |
Evaluate manufacturing performance for quality investigations |
| • |
Understand the technology required to accomplish PAT objectives |
| • |
Quantify the influence of raw material and process variation on product quality |
Who should participate?
The course is intended for researchers, scientists and engineers from all sectors of industry and academia. No prior knowledge of statistics is assumed.
Course schedule
Lunch daily between 12:00 - 13:00 |
| Day one |
| 08:30 |
Introduction and presentation of three kinds of problems: overview, classification, and quantification and prediction. Principal Component Analysis (PCA) for overview of data tables: variable scaling, geometrical interpretation, and model evaluation. PCA examples: quality control of manufacturing, process control (SPC) and environmental monitoring.
Computer exercises followed by discussion. |
| 17:00 |
End of lectures and exercises |
| Day two |
| 08:30 |
Partial Least Squares (PLS): prediction of responses Y from inputs X e.g. spectra, process variables etc.
Variable scaling, geometrical interpretation, algebraic solution and model evaluation.
Multivariate characterisation: quantification of qualitative differences (batches of raw material, chemicals, suppliers). Multivariate calibration: prediction of chemical contents from spectroscopic data.
PLS examples: NIR calibration of API concentration in tablets, mixing of two powders.
Computer exercises followed by discussion. |
| 17:00 |
End of lectures and exercises. |
| Day three |
| 8:30 |
Multivariate batch modelling.
Computer exercises on API manufacture and reaction monitoring. Multivariate process modelling.
Computer exercises and analysis of student data.
Course summary. |
| 17:00 |
End of course |
Cost and conditions
Course fee includes coffee, lunch, and course documentation. Course registration is binding. Cancellations received within two weeks of the course start date will forfeit the entire course fee. If the customer cancels prior to 14 days of the course, 20% of the class fee will be applied to cover processing costs. The balance of class fees already paid to Umetrics may be credited towards a future course. The registering company may substitute its participant(s) provided that Umetrics is notified.
Umetrics holds courses based on a sufficient number of registrants. Therefore, Umetrics reserves the right to cancel the course 14 days prior to the course start date if the number of registrants is too low. Full refund will be made to these registrants. Alternately a 10% refund will be made to any registrant(s) enrolling in the next available course.
Early bird registration: if you book at least 2 months prior to course date the price DISCOUNT is 15%. Also if you are more than three participants from one company booking the same course date you will receive a 10% DISCOUNT/person.
To register, please use the button "Begin registration" in this window frame, or send an email to Umetrics Academy.
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