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.

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