FDA SUPAC Guidance 2015 - How to Implement the FDA SUPAC Guidance

How to Implement the FDA SUPAC Guidance
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
Instructor Profile:
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.
Contact for Registration:
http://www.complianceonline.com/how-to-implement-t...