Applying Risk Management Principles to Drive …
Applying Risk Management Principles to Drive Quality Management System Effectiveness Carlos Monteagudo Director of Quality Assurance Amgen, Inc. PQRI 2nd FDA/PQRI Conference on Advancing Product Quality
System, Management, Quality, Drive, Effectiveness, Drive quality management system effectiveness
Download Applying Risk Management Principles to Drive …
Information
Domain:
Source:
Link to this page:
Please notify us if you found a problem with this document:
Documents from same domain
Regulatory perspectives on CQAs, CPPs, and Risk …
pqri.orgGlobal Regulatory Affairs Regulatory perspectives on CQAs, CPPs, and Risk Analyses for Combination Products. 3rd FDA/PQRI Conference on Advancing Product Quality
Product, Perspective, Regulatory, Risks, Analyses, Combination, Regulatory perspectives on cqas, Cqas, Cpps, Risk analyses for combination products
Hazard & Operability Analysis (HAZOP) 1 Overview
pqri.orgManufacturing 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
pqri.orgManufacturing 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 …
Guide, Analysis, Dome, Failure, Effect, Failure modes and effects analysis guide, Failure modes and effects analysis
CMC Regulatory Considerations for …
pqri.orgCMC Regulatory Considerations for Oligonucleotide Drug Products: FDA Perspective Mohan Sapru, M.S., Ph.D. CMC Lead for Cardiovascular and Renal Products
Drug, Regulatory, Considerations, Cmc regulatory considerations for, Cmc regulatory considerations for oligonucleotide drug, Oligonucleotide
ICH Q12 : A Unique Opportunity to Realize 21st …
pqri.orgICH Q12 : A Unique Opportunity to Realize 21st Century Quality Vision . Moheb M. Nasr . 3rd FDA/PQRI Conference . March 22, 2017
Quality, Opportunity, 21st, Century, Vision, Ich q12, Opportunity to realize 21st, Realize, Opportunity to realize 21st century quality vision
INTRODUCTION TO POLYMER ADDITIVES AND …
pqri.orgINTRODUCTION 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
Introduction, Polymer, Additives, Introduction to polymer additives and, Introduction to polymer additives and stabilization, Stabilization
Thresholds and Best Practices for Extractable and …
pqri.orgOverview of Thresholds and Best Practices for Extractable and Leachables(L&E) 3rd PQRI/FDA Conference on Advancing Product Quality Washington DC, 22 …
Practices, Practices for extractable and, Extractable, Practices for extractable and leachables, Leachables
Harmonization of Requirements Between ICH Q3D …
pqri.orgHarmonization of Requirements Between ICH Q3D and Pharmacopeias Kahkashan Zaidi, USP PQRI/USP Workshop on Elemental Impurities March 31 – April 1, 2015 USP Rockville, Maryland
Requirements, Between, Harmonization of requirements between ich q3d, Harmonization
European reflections on reviewing NDAs and …
pqri.orgEuropean reflections on reviewing NDAs and ANDAs for ICH Q3D elemental impurity compliance Diana van Riet-Nales, Medicines Evaluation Board/NL
European, Compliance, Elemental, Reflections, European reflections on reviewing ndas, Reviewing, Ndas, Ich q3d elemental impurity compliance, Impurity
Recommendations for the Assessment of Blend …
pqri.orgRecommendations 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
Related documents
Certified Pharmaceutical Good Manufacturing …
asq.orgQuality excellence to enhance your career and boost your organization’s bottom line asq.org/certification Certified Pharmaceutical Good Manufacturing
Good, Pharmaceutical, Quality, Certified pharmaceutical good manufacturing, Certified, Manufacturing
(Guidance for Industry: Process Validation: General ...
gmpeye.co.krGuidance for Industry: Process Validation: General Principles and Practices GU053A ggmmppeeyyee www.gmpeye.co.kr 5 생각하는 일반 원칙과 접근 방식을 설명한다.
Stability Testing of Drug Substances and Products ...
www.gphaonline.org777 6th Street, NW • Suite 510 • Washington, DC 20001 • p: 202.249.7100 • f: 202.249.7105 • www.gphaonline.org If significant change or failure occurs within the first 3 months at the accelerated storage
Drug, Testing, Stability, Substance, Stability testing of drug substances
Final Concept Paper Q12: Technical and Regulatory ...
www.ich.orgFINAL Q12 Concept Paper Endorsed: 9 September 2014 -2- An ICH harmonised approach on technical and regulatory considerations for lifecycle
QUALITY SYSTEMS APPROACH - ipapharma.org
www.ipapharma.orgQUALITY SYSTEMS APPROACH FOR CGMP IMPLEMENTATION 3 In the recent years the Indian Pharmaceutical Sector has emerged as one of …