How to Implement the FDA SUPAC Guidance

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.

• 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

• 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?

• 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

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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