2020 - Lifecycle Management of Analytical Methods and Procedures - according to new FDA and USP guidelines

Be able to develop a strategy for analytical procedure lifecycle management
Understand risk management strategies throughout the procedure lifecycle
Understand the concept of measurement uncertainty
Be able to justify and document decisions about type and extend of revalidation after method changes
Be able to define and demonstrate FDA, EU, USP and ICH compliance to auditors and inspectors
Be able to develop inspection-ready documentation during on-going routine operation
Understand what questions will be asked during audits and inspections and how to answer them