Regulatory Commitments Working Group – Update to OPS OD

CMC Regulatory Considerations for …

CMC Regulatory Considerations for Oligonucleotide Drug Products: FDA Perspective Mohan Sapru, M.S., Ph.D. CMC Lead for Cardiovascular and Renal Products

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INTRODUCTION TO POLYMER ADDITIVES AND …

INTRODUCTION TO POLYMER ADDITIVES AND STABILIZATION Bobbijo van Beusichem, Ph.D., Senior Staff Scientist, Expert Services, Michael A. Ruberto, Ph.D., Head of Regulatory Services, NAFTA, Expert Services

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Regulatory perspectives on CQAs, CPPs, and Risk …

Global Regulatory Affairs Regulatory perspectives on CQAs, CPPs, and Risk Analyses for Combination Products. 3rd FDA/PQRI Conference on Advancing Product Quality

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Hazard & Operability Analysis (HAZOP) 1 Overview

Manufacturing Technology Committee – Risk Management Working Group Risk Management Training Guides Hazard & Operability Analysis (HAZOP) Page 1 of 9 1 Overview Hazard and Operability Analysis (HAZOP) is a …

  Analysis, Risks, Hazards, Hazard amp operability analysis, Operability, Hazop

Failure Modes and Effects Analysis Guide

Manufacturing Technology Committee – Risk Management Working Group Risk Management Training Guides Failure Modes and Effects Analysis Guide 1 Overview Failure Modes and Effects Analysis (FMEA) is …

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ICH Q12 : A Unique Opportunity to Realize 21st …

ICH Q12 : A Unique Opportunity to Realize 21st Century Quality Vision . Moheb M. Nasr . 3rd FDA/PQRI Conference . March 22, 2017

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Thresholds and Best Practices for Extractable and …

Overview of Thresholds and Best Practices for Extractable and Leachables(L&E) 3rd PQRI/FDA Conference on Advancing Product Quality Washington DC, 22 …

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Harmonization of Requirements Between ICH Q3D …

Harmonization of Requirements Between ICH Q3D and Pharmacopeias Kahkashan Zaidi, USP PQRI/USP Workshop on Elemental Impurities March 31 – April 1, 2015 USP Rockville, Maryland

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European reflections on reviewing NDAs and …

European reflections on reviewing NDAs and ANDAs for ICH Q3D elemental impurity compliance Diana van Riet-Nales, Medicines Evaluation Board/NL

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Recommendations for the Assessment of Blend …

Recommendations for the Assessment of Blend and Content Uniformity: Modern Approaches to Sampling and Testing James K. Drennen, III drennen@duq.edu

  Assessment, Recommendations, Recommendations for the assessment of

Regulatory Expectations of Presentation of Dissolution Data

Safeguarding public health Regulatory Expectations of Presentation of Dissolution Data David Darling Pharmaceutical Assessor Medicines and Healthcare products

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GUIDELINE ON SUBMISSION OF DOCUMENTATION FOR A …

working document qas/13.522/rev.1 page 2 36 37 schedule for the proposed adoption process of document 38 qas/13.522: 39 guidelines on submission of documentation for a multisource