'Process understanding' diaporamas de présentation

Process Analytical Technology: Neue Trends in der Pharmaceutischen Industrie

Process Analytical Technology: Neue Trends in der Pharmaceutischen Industrie. Dr. Fritz Erni NOVARTIS Pharma Global Quality Operations CH-4002 Basel, Switzerland. Outline. The Vision of the desired state What is PAT and QbD ICH Q8 is a Door Opener for Describing Quality by Design

931 views • 44 slides

Quality by Design The Challenge for Regulators

Quality by Design The Challenge for Regulators. Summary of New Thinking Path for Development of Review Considerations Not yet FDA policy. Jon Clark Associate Director for Policy Development Office of Pharmaceutical Science Center for Drug Evaluation and Research, FDA. Overview.

516 views • 38 slides

Critical Path Initiative: Challenges and Opportunities

Critical Path Initiative: Challenges and Opportunities. Ajaz S. Hussain, Ph.D. Deputy Director, Office of Pharmaceutical Science, CDER, FDA 19 October 2004 ACPS Meeting. CDER Goals: 2005. State of CDER 2004; Steven Galson & Doug Throckmorton October 6, 2004. What is Critical Path?.

566 views • 36 slides

Changes Without Prior Approval

Changes Without Prior Approval. How do we get there from here?. Jon Clark Associate Director for Policy Development Office of Pharmaceutical Science Center for Drug Evaluation and Research, FDA ACPS Manufacturing Subcommittee July 21, 2004. Overview.

551 views • 36 slides

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Introduction to Organizational Communication

Introduction to Organizational Communication. A Competency-Based Approach Chapter One. The Changing Nature of Organizations and Work. We are in transition from an information age to a knowledge age with rapid change in familiar institutions and organizations.

548 views • 27 slides

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3k views • 22 slides

Adaptive modelling of water quality using real time data from lake observatories - can we do it?

Adaptive modelling of water quality using real time data from lake observatories - can we do it?. Dr. Matthew Hipsey School of Earth & Environment University of Western Australia GLEON8: New Zealand, Feb 2009. Models as Virtual Environmental Laboratories.

358 views • 20 slides

by Michael Moran NAWQA VOC National Synthesis

Using logistic regression to predict the probability of occurrence of volatile organic compounds in ground water. by Michael Moran NAWQA VOC National Synthesis. NAWQA VOC Monitoring. Cycle 1 Ground Water Sampling. ? 3,883 NAWQA-sampled wells analyzed for 55 target VOCs.

302 views • 19 slides

by Michael Moran NAWQA VOC National Synthesis

Using logistic regression to predict the probability of occurrence of volatile organic compounds in ground water. by Michael Moran NAWQA VOC National Synthesis. NAWQA VOC Monitoring. Cycle 1 Ground Water Sampling. ? 3,883 NAWQA-sampled wells analyzed for 55 target VOCs.

193 views • 19 slides

PhRMA Perspective on FDA Final Report

PhRMA Perspective on FDA Final Report. FDA Advisory Committee on Pharmaceutical Sciences October 20, 2004 G.P. Migliaccio, Pfizer Inc. Discussion Topics. Culture Change General Comments on Report Quality Systems Guidance Risk-Based Inspection Model

275 views • 18 slides

Q-IWG Status update

Q-IWG Status update. Georges France. ICH Q8, Q9 & Q10 A real opportunity. Benefit of a New Paradigm A life cycle approach: A focus investment during the development with the benefit at the manufacturing Process Understanding Process Capability and Robustness

170 views • 16 slides

Thank you for your attention!

Thank you for your attention!. Forests and water: process understanding and international momentum. Thomas Hofer, FAO. Achieving the Millennium Development Goals. MDG 7: Ensure environmental sustainability Target 7c: Reduce by half the proportion of people

229 views • 14 slides

PSMI Panel Breakout 2012 US CLIVAR Summit, Newport Beach, CA

PSMI Panel Breakout 2012 US CLIVAR Summit, Newport Beach, CA. Introductions Orientation Breakout Aims. PSMI Panel Membership, February 2012. PSMI Panel Institution Through J. Thomas Farrar Woods Hole Ocean. Inst. Dec 2014

231 views • 9 slides

CPI National Biologics Manufacturing Centre (NBMC)

CPI National Biologics Manufacturing Centre (NBMC). Horizon 2020, Brussels 16/12/2013. SPIRE-1. Core Capability. Fermentation High Throughput Screening Scale-up. Ultrafiltration / Diafiltration Product Purification. Formulation & Fill. Core Capability & Quality by Design.

74 views • 7 slides