Qualification of Process Analytical Technology (PAT) Based Control Strategies for Batch & Continuous Manufacturing


Instructor: Michael Levin
Product ID: 706771

  • Duration: 60 Min
This seminar will provide an insight into the practical aspects of the Process Analytical Technology (PAT) batch and continuous manufacturing of pharmaceutical products. You will learn about regulatory initiatives to improve the quality of solid dosage pharmaceutical manufacturing using PAT. No special technical background is required.
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Areas Covered in the Webinar:

This webinar course covers the following topics on batch and continuous manufacturing:

  • The purpose of PAT in manufacturing.
  • Use of spectroscopic methods in real-time
  • Use of near-infrared (NIR) techniques to monitor powder blends or core tablets for API or moisture content.
  • Use of NIR and Raman spectrometry to monitor film coat thickness or physical form in core or coated tablets.
  • Use of laser diffraction methods to measure and control particle sizes in granulated products.
  • Review of PAT sensors and their use in continuous material transfer, blending, spray drying, roller compaction, granulation, and direct compression.
  • Method development and life cycle considerations for PAT in manufacturing.
  • Instrument selection, sampling techniques, reference values, calibration, multivariate analysis, sensitivity, accuracy and precision.
  • Validation and maintenance.
Who Will Benefit:

This seminar is intended for production operators and managers, process engineers, and validation specialists dealing with process and product quality assurance. It will also provide a good source of information for anyone involved in risk mitigation and regulatory compliance.

Instructor Profile:
Michael Levin

Michael Levin
Owner and General Manager, Measurement Control Corporation

Michael Levin, Ph.D., has edited a very popular “Pharmaceutical Process Scale-Up” handbook (3rd edition published in 2011), and has contributed chapters on “Tablet Press Instrumentation” and “Wet Granulation: End-Point Determination and Scale-Up” in the Encyclopedia of Pharmaceutical Technology. For more than 30 years he has managed an instrumentation company providing monitoring and real-time process data on pharmaceutical solid dosage equipment.

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