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2021 - How to Implement the FDA SUPAC Guidance
Topics/Call fo Papers
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?
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?
Other CFPs
Last modified: 2021-09-30 10:32:05