0 h 58 min
In this webinar, we will share the latest trends in feedback received from the FDA concerning extractables chemistry testing. This session will provide valuable insights into the level of detail expected by the FDA in various aspects of extractables testing, including identifications, compound reporting, and method descriptions.
What You Will Learn:
- Level of Identification Expected: Understand the FDA’s expectations for the identification of compounds during extractables testing. Learn how to accurately identify compounds and how this information should be reported to meet regulatory standards.
- Level of Quantification Expected: Gain insights into the FDA’s requirements for the quantification of compounds. Discover what evidence is necessary to support quantification levels and ensure compliance with regulatory guidelines.
- Detail in Chemistry Reports: Learn about the amount of detail recommended in chemistry reports. Understand how to effectively document and describe methods, findings, and conclusions to satisfy FDA expectations.
Key Takeaways:
- Detailed knowledge of FDA expectations for extractables chemistry testing.
- Practical tips on how to report compound identifications and quantifications.
- Best practices for preparing comprehensive and compliant chemistry reports.
This webinar is designed for professionals involved in the chemical characterization and regulatory submission of medical devices and pharmaceutical products. By attending, you will be better equipped to align your extractables testing processes with FDA requirements, ensuring smoother regulatory reviews and approvals.