How to Implement the FDA SUPAC Guidance


Instructor: Michael Levin
Product ID: 704312

  • Duration: 60 Min
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.
Last Recorded Date: Nov-2021


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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
Instructor Profile:
Michael Levin

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.

Frequently Asked Questions:

  1. Will there be any discussion of sterile processes or liquid manufacturing (not SOD)?
  2. Does the SUPAC guidance applies to other formulations like oral solution for post approval changes?
  3. Can you lead me to the guidance to verify? I'm not changing the sterile process, but the liquid process prior to sterile functions.
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Our refund policy is governed by individual products and services refund policy mentioned against each of offerings. However in absence of specific refund policy of an offering below refund policy will be effective.
Registrants may cancel up to two working days prior to the course start date and will receive a letter of credit to be used towards a future course up to one year from date of issuance. ComplianceOnline would process/provide refund if the Live Webinar has been cancelled. The attendee could choose between the recorded version of the webinar or refund for any cancelled webinar. Refunds will not be given to participants who do not show up for the webinar. On-Demand Recordings can be requested in exchange. Webinar may be cancelled due to lack of enrolment or unavoidable factors. Registrants will be notified 24hours in advance if a cancellation occurs. Substitutions can happen any time. On-Demand Recording purchases will not be refunded as it is available for immediate streaming. However if you are not able to view the webinar or you have any concern about the content of the webinar please contact us at below email or by call mentioning your feedback for resolution of the matter. We respect feedback/opinions of our customers which enables us to improve our products and services. To contact us please email [email protected] call +1-888-717-2436 (Toll Free).




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