Process Validation and ICH Q7 – David Amspacher.Common Issues Related to LC and GC Methods in Type II DMFs – Xinghua Wu.ICH Q11 Q&A, a Supporting Document for the Selection and Justification of Starting Materials – Anita Tiwari.Drug Substance Facilities – Hidden and Critical Intermediate – Cassandra Abellard & Wei Liu.Poster Presentations: Responses to Submitted Questions (Day One).Effective Communication Strategies for Drug Master Files (DMF) – David Skanchy & Benjamin Danso.Timely Consult and Early Information Request (TCIR) Process for Drug Master Files (DMFs) – Jayani Perera. Drug Master Files from a GDUFA II User Fee Perspective – Hanah Pham & Evelyn Hong.Managing Electronic DMF Submissions – Jonathan Resnick.Administrative Aspects of Managing a DMF – Vathsala Selvam.Introduction to the DMF Review Process – Erin Skoda.
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