SANTE Guidance Document Updates
Smithers has created a guide that discusses and evaluates the expectations of the new SANTE guidance document.
Webinar: SANTE Method Validations – Evolving Analytical Strategies
Since its inception in February 2021, SANTE/2020/12830 has been critical to the validation of robust and globally accepted analytical methods for risk assessment and post-approval control and monitoring. While SANTE-compliant analytical method validation approaches and procedures are becoming more established, some challenges still remain. Additionally, as of April 2023, SANTE/2020/12830 rev. 2 has been published which will impact analytical method validations going forward.
In this webinar, Smithers Study Director Andrea McGuinness will offer a brief review of SANTE/2020/12830 rev. 1 and highlight some of the strategies developed and lessons learned through its continued use in producing SANTE-compliant analytical method validations. Andrea will also discuss the ongoing challenges presented by this guidance document, as well as what to expect from the recent update to SANTE/2020/12830 rev. 2.
Our Expert:
Andrea McGuinness, Study Director, Wareham, Massachusetts, US Andrea McGuinness performs method validations in support of ecotoxicology testing, as well as management of the GC and LC-MS/MS instrument labs. She has expertise in development of GLP SANTE method validation protocols to support ecotoxicology studies.
Date: Wednesday, June 21, 2023
Time: 9:00am ET