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How to Implement the FDA SUPAC Guidance

Event Details

How to Implement the FDA SUPAC Guidance

Time: November 18, 2021 from 10am to 1pm
Location: online
Website or Map: https://www.complianceonline.…
Event Type: webinar
Organized By: ComplianceOnline
Latest Activity: Oct 4

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Event Description

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?

Who Will Benefit:

  • Formulators
  • Process engineers
  • Validation specialists
  • Quality assurance personnel
  • Production managers occupied with process and product scale-up and changes in any FDA approved production
  • Anyone involved in technology transfer and product globalization

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