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How to Develop a PAT Approach in your R&D and Production Webinar  

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Online Compliance Panel   

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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.

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Seminar Summary:

This webinar course covers the following topics on Process Analytical Technology, regulatory impact of implementing pat approach in R&D and production (see full course description)

 

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Training Course Syllabus:


How to Develop a PAT Approach in your R&D and Production Webinar

Time: 10:00 AM PDT | 01:00 PM EDT

Duration: 60 Minutes

Instructor: Michael Levin

Description:

This webinar course covers the following topics on Process Analytical Technology:

  • What is FDA PAT Initiative and how to comply with innovation requirements?

  • 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

Why Should you Attend:

This webinar will provide an insight into the practical aspects of the Process Analytical Technology and will be an invaluable source of information on various technologies and approaches that fit the PAT definitions.

Objectives of the Presentation:

This presentation aims at teaching participants about:


  • The fundamental concepts behind the FDA PAT initiative

  • Regulatory impact of implementing PAT approach in R&D and production

  • Use of multivariate data analysis (MVDA) and statistical process control

  • Efficient on-line and at-line tools for predicting quality attributes based on process data

  • Design space verification and real time quality assurance

  • Tools for root cause determination, trending analysis and visualization

Seminar Summary:

This webinar course covers the following topics on Process Analytical Technology, regulatory impact of implementing pat approach in R&D and production (see full course description)

print this agenda print agenda for the How to Develop a PAT Approach in your R&D and Production Webinar training seminar

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