CESPE Academy - Process Analytical Technologies
Beschrijving
To support both innovation and efficiency in pharmaceutical development, manufacturing, and quality assurance, the FDA proposed its process analytical technology or PAT framework (2004). The framework is founded on process understanding to facilitate innovation and risk-based regulatory decisions by industry and the Agency.
During this course, a basic introduction will be given on the implementation of process analytical tools (PAT) in the field of the pharmaceutical industry. An overview will be provided on the PAT-tools which are commonly used in the field including both spectroscopic and non-spectroscopic sensors. In addition, attendants will learn how, when and where these tools can provide a benefit to the pharmaceutical manufacturing process.
During a 2.5-day training, participants will learn to explore uni- and multivariate data and make predictive models using real spectroscopic data.
- Module 1: Basic course: Introduction to PAT (1-day)
- Module 2: Basic data-analysis and modeling (1.5-day)
Programma
Opmerkingen
Additional information
- One week prior to the course, the registered participants will receive further information (directions, parking availabilities, course material).
- Upon completion of the training, a certificate of attendance will be made available on the platform.
- Additionally, the participant will receive an evaluation form to provide feedback on this training.
Annulation/Cancelation
Registration is possible up to one week before the day of the respective session.
Registrations can only be canceled by email, up to one week before the day of the respective course. After that, the full registration fee will still be due in case of cancellation.
A participant unable to attend can always be replaced by a colleague or can request a voucher for a similar training on a later date!
A minimum attendance of 5 participants is required to conduct the training. Otherwise the organization reserves the right to reschedule or cancel the training!
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Module 1 - Basic Course: Introduction to PAT
MODULE 1: BASIC COURSE
Theoretical
General introduction to PAT
a. Basic fundamentals
b. What is the scope?
Choosing the appropriate PAT sensor
a. Spectroscopic sensors
b. Non-spectroscopic sensors (Univariate/Multivariate)
Basic understanding of hyperspectral imaging
a. Basic fundamentals
b. What is the scope?
c. Sensors
How can PAT be used?
a. PAT in R&D/Process Validation/QbD
b. Process control based on PAT
Regulatory aspects and hurdles
a. What is the current regulatory status?
b. What hurdles are there currently?
Sneak-peak into Multivariate data analysis
a. Basic fundamentals
Practical
Hands-on session: Use and implementation of NIR
a. How to implement the system?
b. What kind of data do you get out of it?
Hands-on session: Use and implementation of Raman
Hands-on session: Use and implementation of FLIR
Basic understanding of spectroscopy and pharmaceutical manufacturing techniques is required.
Basic understanding of coding and programming is recommended.
Target audience
People with no experience/expertise in the topic and those that want a refreshment on the basic principles.
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Module 2 - Basic Data-analysis and Modeling
MODULE 2: BASIC DATA-ANALYSIS AND MODELING
General introduction to Python
a. Basic coding principles
b. How can we use Python for PAT data?
c. Advantages compared to commercial software
Data preparation and exploration
a. Data pre-treatment aspects
b. Exploratory analysis
Introduction to modeling
a. Overview of linear and non-linear univariate models
b. Introduction to PCA
c. Introduction to PLS
d. Multivariate data-analysis
i. Introduction to modeling in SIMCA
ii. Introduction to modeling in Python
Process control based on PAT
a. Looking at your data, which predictive models can you implement?
b. How can you control the process based on your developed models?
Basic understanding of spectroscopy and pharmaceutical manufacturing techniques is required.
Basic understanding of coding and programming is recommended.
Target audience
People with no experience/expertise in the topic and those that want a refreshment on the basic principles.
Inschrijven
PACKAGE: Module 1 & 2
This package combines Module 1 & 2 starting from the basic concepts and ending with a focus on specific PAT-tools.
Basic understanding of spectroscopy and pharmaceutical manufacturing techniques is required.
Basic understanding of coding and programming is recommended.
Target audience
People with no experience/expertise in the topic and those that want a refreshment on the basic principles.