Process Analytical Technology (PAT): The Impact on Pharmaceuticals Manufacturing and Validation Needs/Requirements
Instructor:
Michael Levin
Product ID: 701147
- Duration: 60 Min
This webinar course covers the following topics on Process Analytical Technology:
- What is FDA PAT Initiative and how to comply with innovation requirement
- FDA PAT Guidance Q&A with examples
- Multivariate data acquisition and analysis tools
- Modern process analyzers
- Process and endpoint monitoring and control tools
- Current GMP practices, QbD and Risk based PAT framework
- Life Cycle Validation approach applied to analytical technology
This webinar is intended for formulators, process engineers, validation specialists and quality assurance personnel, as well as production managers occupied 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
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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