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How to Implement the FDA SUPAC Guidance

Nov 18 2021 - Thursday 10:00 AM PST | 01:00 PM EST 60 Min

Sponsored by ComplianceOnline

Click Here to register $199.00

Click Here to register and receive  recording $499.00

This webinar training will cover various topics on Scale-Up and Post-Approval Changes (SUPAC). Participants will learn how to properly scale-up or scale-down pharmaceutical batch process and learn the standard set of documentation to successfully support post-approval changes.

Why Should You Attend:

This webinar will provide an excellent insight into the practical aspects of the process scale-up and will be an invaluable source of information on batch enlargement and technology transfer techniques and regulatory requirements. Participants will learn about regulatory FDA and EU guidelines regarding scale-up and post-approval changes.

Learning Objectives:
  • Basic scale-up science
  • Regulatory impact of change control of approved drug manufacturing process
  • How to properly scale-up or scale-down your pharmaceutical batch process
  • Standard set of documentation to successfully support post-approval changes
  • Managing the technology transfer process
Areas Covered in the Webinar:
  • SUPAC IR: Immediate Release Q&A with Examples
  • SUPAC MR: Modified Release Q&A with Examples
  • SUPAC: Manufacturing Equipment Addendum Q&A with Examples
  • Risk Based CMC Regulatory Oversight of Post-Approval Change
  • What kind of documentation do you need when scaling up your process to comply with the FDA SUPAC Guidance?
  • What kind of documentation do you need to comply with the FDA SUPAC Guidance when moving your approved process to different equipment?
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.