ON-DEMAND WEBINAR: Elemental Impurities - Missed the Deadline? Now What?
It’s official! The methods outlined in USP General Chapter <231> are retired. If you missed the January 1, 2018 deadline, we are here to help. Our in-house experts will share our approved testing plan that can be submitted to the FDA to help ensure you are moving to compliance and will highlight experiences gained while working with the new regulations.
Join us for a webinar to discuss:
- A brief summary of the regulatory change, impacts, and timelines
- Overview of Alcami’s testing timelines
- Benefits of semi-quantitative screening
- Method development
- Risk assessment testing
- Method validation and release testing
- Elemental Impurities Risk Assessment Regulatory Report
- Considerations regarding lifecycle management of drug products
Length: 45 minutes