 | ||
|
Keynote Speaker for this Event:
|
Sponsored by:
|
This presentation provides an introduction to the regulatory documents surrounding leachables and extractables testing requirements for pharmaceutical products intended for US submission.
The regulatory documents covered will include those for MDI, DPI, nasal spray, topical, oral and parenteral drug products. In addition to FDA guidance for container closure systems and devices, the presentation will explore other applicable guidance and recommendation documents including: ICH guidance, Product Quality Research Institute (PQRI) recommendations and EMEA and FDA guidance on genotoxic and carcinogenic impurities.
Finally, flowcharts on how to put the guidance into action will be shown including component selection for study, analytical technology to employ and overall extractables and leachables program strategy.
Key takeaways:
- An understanding of the regulatory documents surrounding extractables and leachables testing
- Modern approaches and strategy to extractables and leachables testing
- Putting the guidance into action in the analytical laboratory
Access to this archive is given on the understanding that you agree to the provision of your contact information to Xtalks sponsors and partners. Only primary contact information will be shared and this information will only be shared for the purposes of providing relevant offers. This registration form is an application only. Xtalks has the right to refuse access.
If you require help with your registration or have any questions you may contact Xtalks at: email: register@xtalks.com; phone: 416-977-6555, x 371.
By completing this registration form, you agree that the information you have provided is true and accurate.
(note: fields with marked "*" are required)