3-Hour Virtual Seminar on Bioanalytical Method Validation
May 5, 2021 - CA USCompliance4All
compliance4all14@gmail.com
Phone:8004479407
Overview: The FDA updated its Guidance for Industry as it relates to validating methods for drugs and biologics. These methods include analytical procedures that test for identity, purity, potency, and stability of drug substances and drug products. Clinical laboratories also must follow stricter procedures for accreditation and validation of test methods per current ISO requirements. Selecting the right method to validate or if a method is ready for validation starts with the research lab or method development lab and data that support the decision to proceed. Tight timelines or inadequate method development data can lead to premature advancing of a method to validation. Rushing into validation can lead to failed validation runs involving repeating assay runs.