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| System for Continued Process Verification A System for Continued Process Verification (Webinar length: 1h 29m) “Continued Process Verification” is the focus of Stage 3 of the 2011 FDA Process Validation Guidance. A system that addresses this need is presented. The system utilizes systems thinking and statistical engineering principles to integrate the tools needed to implement and operate such a system. Central to the approach are state-of-the-art Process Control, Quality by Design and Design of Experiments concepts, methods and tools that are used to create the needed process understanding. The system integrates process control with process improvement and process design. These elements are described and the decision mechanisms for deciding how to move from one element to another are discussed. Pharma and biotech case studies are used throughout the presentation to illustrate how the various parts of the approach work together. Benefits to Webinar Participants: How to design and implement continued process verification systems How to integrate process control, process and process design Awareness of QbD and its role in creating robust manufacturing processes How to sequence and link the QbD building blocks to create process understanding Guiding principles, tips and traps for the effective process verification systems Webinar Leader: Ronald D. Snee, PhD Ron Snee is Founder and President of Snee Associates, a firm dedicated to the successful implementation of process and organizational improvement initiatives. He provides guidance to senior executives in their pursuit of improved business performance using Quality by Design, Lean Six Sigma and other improvement approaches that produce bottom line results. He has played a leadership role in 28 major improvement initiatives for firms such as Novartis, Schering Plough, Human Genome Sciences, Boehringer-Ingelheim and Kraft Foods. Prior to his consulting career he spent 24 years at the DuPont Company in a variety of assignments including pharmaceuticals. He has been developing and applying Strategy of Experimentation and QbD methodologies for more than 30 years. His recent application and research on QbD has produced eight articles on use of QbD in Pharma and Biotech. He has also coauthored 2 books on the methods and tools of QbD and speaks regularly at conferences and meetings on the subject. He teaches QbD and related methodologies as an Adjunct Professor at Temple University School of Pharmacy. Ron received his BA from Washington and Jefferson College and MS and PhD degrees from Rutgers University. He is an academician in the International Academy for Quality and Fellow of the American Society of Quality, American Statistical Association, and American Association for the Advancement of Science. He has been awarded ASQ’s Shewhart and Grant Medals, and ASA’s Deming Lecture Award as well as numerous other awards and honors. He is a frequent speaker and has published 4 books and more than 225 papers in the fields of performance improvement, quality, management, and statistics. He is a past recipient of the Institute of Validation Technology Speaker of the Year Award. Webinar Price ($289) Click here to buy it Copyright (C) All rights reserved. FoodHACCP.com. For more information send email to info@foodhaccp.com TEL) 1-866-494-1208 FAX) 1-253-486-1936 |
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