How to Develop a PAT Approach in your R&D and Production Webinar training seminars presented by 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.
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)