About FDA
-
Public Presentations
Presentations 2012
-
IFPAC Annual Meeting January 22-25, 2012
Evaluation of Process Models with Monte Carlo Methods, John Kauffman, Sharmista Chatterjee, Jean-Marie Geoffroy, January 22, 2012, IFPAC Annual Meeting (PDF - 986KB)FDA Perspective on Continuous Manufacturing, Sharmista Chatterjee, Ph.D., January 22, 2012, IFPAC Annual Meeting (PDF - 309KB)Regulatory Considerations for Utilization of Near-Infrared (NIR) Spectroscopy in Process Monitoring and Control, Bogdan Kurtyka, Ph.D., January 22, 2012, IFPAC Annual Meeting (PDF - 55KB)A Regulatory Perspective on NIR Method Robustness, Yubing Tang, Ph.D., January 25, 2012, IFPAC Annual Meeting (PDF - 72KB)
-
-
International Conference on Drug Development February 27-29, 2012
-
-
AAPS Annual Meeting October 14-18, 2012
Design Space Considerations, Sharmista Chatterjee, Ph.D., October 14, 2012, AAPS Annual Meeting (PDF - 750KB)Analytical Challenges for Orally Inhaled and Nasal Drug Products (OINDPs), CDER Perspective, Edwin Jao, October 17, 2012, AAPS Annual Meeting (PDF - 79KB)Regulatory Perspective on Implementation of Multivariate Statistical Process Control for Pharmaceutical Manufacturing, Bogdan Kurtyka, PhD., October 17, 2012, AAPS Annual Meeting (PDF - 219KB)Content Uniformity (CU) testing for the 21st Century: CDER Perspective, Richard (Rik) Lostritto, Ph.D., October 17, 2012, AAPS Annual Meeting (PDF - 311KB)CDER Implementation of: The United States Pharmacopeia (USP) <1121> Monograph Naming Policy for Salt Drug Substances in Drug Products, Richard (Rik) Lostritto, Ph.D., October 17, 2012, AAPS Annual Meeting (PDF - 266KB)Regulatory Assessment of Applications Containing QbD Elements - Reviewer Experience, Sarah Pope Miksinski, Ph.D., October 14, 2012, AAPS Annual Meeting (PDF - 495KB)Regulatory Considerations for Antibody-Drug Conjugates, Sarah Pope Miksinski, Ph.D. (ONDQA), Marjorie Shapiro, Ph.D. (OBP), October 18, 2012, AAPS Annual Meeting (PDF - 338KB)- Regulatory Perspectives on Drug Development Challenges Faced By Small Companies, Elaine Morefield, Ph.D., October 16, 2012, AAPS Annual Meeting (PDF - 327KB)
Control Strategy and ICH Q11, John Smith, Ph.D., October 18, 2012, AAPS Annual Meeting (PDF - 336KB)Establishing Clinically Relevant Drug Product Specifications: FDA Perspective, Sandra Suarez Sharp, Ph.D., October 16, 2012, AAPS Annual Meeting (PDF - 949KB)
-
Presentations 2011
-
AAPS Annual Meeting October 23-27, 2011
Role of Models in the Quality by Design (QbD) Paradigm: Regulatory Perspective, Sharmista Chatterjee, Ph.D., October 23, 2011, AAPS Annual Meeting (PDF - 462KB)CMC Considerations for 505(b)(2) Applications, Monica Cooper, Ph.D., October 23, 2011, AAPS Annual Meeting (PDF - 123KB)Current FDA Perspective on Leachable Impurities in Parenteral and Ophthalmic Drug products, David B. Lewis, Ph.D., October, 2011, AAPS Annual Meeting (PDF - 134KB)CMC Considerations for a Successful Regulatory Submission, Rapti D. Madurawe, Ph. D., October, 2011, AAPS Annual Meeting (PDF - 211KB)An FDA Perspective on Drug Development and the Global Regulatory Landscape, Christine M. V. Moore, Ph.D., October, 2011, AAPS Annual Meeting (PDF - 516KB)Regulatory Perspective on Real Time Release Testing (RTRT), Christine M. V. Moore, Ph.D., October, 2011, AAPS Annual Meeting (PDF - 402KB)Quality by Design Approaches to Analytical Methods -- FDA Perspective, Yubing Tang, Ph.D., October, 2011, AAPS Annual Meeting (PDF - 140KB)Case Studies: Models for Establishing Clinically Relevant Drug Product Specifications, Sandra Suarez Sharp, Ph. D., October, 2011, AAPS Annual Meeting (PDF - 393KB)FDA Perspective on Achieving Product Quality Over Shelf Life, Richard (Rik) Lostritto, Ph.D., October, 2011, AAPS Annual Meeting (PDF - 47KB)Current FDA Thinking on Stability Practices for New Drug Products, Ramesh Sood, Ph.D., October, 2011, AAPS Annual Meeting (PDF - 74KB)
-
-
-
