Common CMC Issues in Type II DMFs and How to Avoid Them – Wei Liu.

Drug Substance Postapproval Changes Guidance: Determination of Impurity Profile Equivalence – Brian Connell.API Facility Inspections – Jay Jariwala.Poster Presentations: Responses to Submitted Questions (Day Two).Nitrosamines: Where Are We Now? – Deborah F.Safety Evaluation of Drug Substance Impurities in Generics – Chanchal Gupta.Application of (Q)SAR and Expert Knowledge for ICH M7 Impurity Classification – Naomi L.ICH M7(R1) – Chemistry and Manufacturing Control (CMC) Perspective on Hazard Assessment – Barbara O.

Regulatory Considerations for Impurity Qualification: ICH Q3A/Q3C/Q3D, RLD & MDD – Hongbiao Liao.

Regulatory Considerations in Demonstrating Complex API Sameness – Bapu R.

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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