ComplianceOnline

How to Properly Monitor Process and Performance of Pharmaceutical Solid Dosage Equipment

Instructor: Michael Levin
Product ID: 704274
  • Duration: 60 Min

recorded version

$229.00
1x Person - Unlimited viewing for 6 Months
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Recorded Link and Ref. material will be available in My CO Section

Training CD

$399.00
One CD is for usage in one location only.
(For multiple locations contact Customer Care)
CD and Ref. material will be shipped within 15 business days

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Read Frequently Asked Questions

Among other key topics, this training program will focus on what can be monitored in mixing operations, wet granulation operations, dry granulation operations, compaction operations, and coating operations.

Why Should You Attend:

This webinar will provide an insight into the practical aspects of the process monitoring technology and will be an invaluable source of information on various methods and approaches that will allow you to optimize solid dosage processes in both R&D and production. Attendees will learn about regulatory guidance and requirements designed to improve real-time process monitoring and control, as well as technical aspects of various instrumentation techniques.

Learning Objectives:

  • What can be monitored in mixing operations
  • What can be monitored in wet granulation operations
  • What can be monitored in dry granulation operations
  • What can be monitored in compaction operations
  • What can be monitored in coating operations
  • PAT guidance and process monitoring devices
  • Monitoring for real-time quality management
  • FDA guidance and methodologies for risk-based monitoring

Areas Covered in the Webinar:

  • Data-driven fault diagnosis and process monitoring methods
  • Code of Federal Regulations Title 21
  • Monitoring and control of process parameters and component and device characteristics during production
  • Pharmaceutical industry basic unit operations
  • Quality by Design (QbD) and modern process monitoring systems
  • Process and endpoint monitoring and control tools
  • Current GMP practices and risk-based PAT framework

Who Will Benefit:

  • Formulators
  • Process engineers
  • Validation specialists
  • Quality assurance personnel
  • Production managers occupied with process and product quality assurance

Instructor Profile:

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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