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
- 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?
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.