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.
- 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:
- 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