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A QbD and lifecycle management approach to analytical method development and qualification will result in a better understanding and fewer failures of analytical methods due to more robust methods which produce consistent, reliable, quality data throughout the lifecycle. This, in turn, will lead to less method transfer failures, OOS results and method "incidents" when used in the routine environment. As the industry is now applying Quality by Design (QbD) to process development, it is now being recognized that this is also the way forward to improve and standardise our approach to analytical procedures. This two day training course presents a brief overview of method validation according to ICHQ2 (R1) and discusses the limitations of this approach in terms of its contribution to failure of methods with regards to method transfer and generation of OOS results later in the method lifecycle. It then illustrates that the lifecycle approach is a holistic process which embraces the philosophies of the traditional approach but results in more robust analytical procedures. Finally a comparison of the current approach (ICHQ2) and the QbD approach is presented. The course focuses on HPLC methods; therefore experience in developing, validating and transferring analytical HPLC methods would be an advantage to participants. The material is presented by means of slides, handouts and participation of the attendees through discussion, case studies and hands on group exercises. This course is designed to provide training in how to apply Quality by Design and lifecycle management to the development and qualification of analytical methods. It aims to highlight the limitations of the current approach to method validation (ICHQ2) and the benefits to using the QbD approach. Although the QbD and Lifecycle management approach is not yet officially recognised for analytical methods, the course is based on the approach used for manufacturing processes and products as described in ICH Q8, Q9 and Q10. The course emphasises practical issues such as: • Comparison of the traditional approach and QbD/lifecycle approach to analytical methods • Applying the QbD and lifecycle approach to development and qualification of analytical methods • Exploring and controlling variables of analytical methods
The European Symposium on Polymer Spectroscopy (ESOPS) is held every two to three years to review the latest research and development in the spectroscopic characterization and analysis of polymer systems. Contributions from all fields of spectroscopy are welcome (infrared, NIR, Raman, fluorescence, NMR, EPR, mass spectroscopy, dielectric and mechanical spectroscopy). The scope of the meeting ranges from theoretical and fundamental aspects to recent advances and novel developments in characterization and analysis of polymers. The symposium brings together scientists specialized in different spectroscopic techniques, giving them the opportunity to broaden their minds beyond their individual fields of work. The symposium is intended not only for those who are actively engaged in the field, from both academia and industry, but also for those wishing to become acquainted with the latest developments.
Whether you are developing a brand new process or optimizing an existing synthetic route, the aims are always the same: • Achieving greater process efficiency, yield and throughput. • Eliminating unsafe and non-green processes and materials. • Decreasing the costs and number of steps involved. Since the first conference in 1994, The Scale-Up of Chemical Processes has become the major international forum for the discussion of all these aspects of scale-up and more in the pharmaceutical, fine chemical and allied fields. Key speakers will present case studies and examples of some of the pitfalls and problems they encountered and how they overcame them. With unparalleled networking opportunities, this broad-based conference is the best place to learn about and discuss the latest novel ideas and techniques with the key people in the industry.
As part of the festivities of the golden jubilee of COPPE, the graduate school of Engineering of the Federal University of Rio de Janeiro, the Membrane Separation Processes Laboratory of COPPE is celebrating 45 years of activities on fundamental research and technology development on the applications of synthetic membranes. SIMPAM 2013 has been organized to celebrate this special anniversary and will be held between July 29 and August 02, in Rio de Janeiro, Brazil. In addition, two workshops were included as special events: the I Workshop on Gas Separation and the I Workshop on Ion Separation and Pre-treatment. The main objectives are to bring out and discuss with the Brazilian and the international scientific and technical community the recent research in Membrane Science and Technology developed throughout the country. The scientific program consists of plenary lectures which will cover the state-of-art in selected areas, highlighting the main challenges for the future, delivered by international membrane experts, from academia and industry. About 100 selected papers will be presented for the oral and poster sessions. Main topics include membrane formation and characterization; membrane processes such as MF, UF, NF, ED and RO and their hybrid operations; energy generation; pervaporation and vapor permeation; gas separation; and membrane bioreactors (MBR).
Drug Discovery Design Methods & Applications: Structure-based drug design, cheminformatics, bioinformatics and molecular modelling supporting drug design and discovery, a Hands-on 5 Day eCheminfo Workshop. Case Study Focus on Malarial Kinases.
Join the Royal Society of Chemistry for the twelfth conference in the International Symposia on Advancing the Chemical Sciences (ISACS) series – Challenges in Chemical Renewable Energy (ISACS12). This significant event will bring together exceptional researchers for an outstanding plenary programme exploring the themes of photovoltaics, solar fuels, new battery materials, fuel cells and molecular catalysis. Confirmed Speakers • Fraser A. Armstrong, UK • Matthias Beller, Germany • Peter G. Bruce, UK • Emily A. Carter, USA • Ib Chorkendorff, Denmark • Holger Dau, Germany • Richard Friend, UK • Shunichi Fukuzumi, Japan • Harry B. Gray, USA • Sossina M. Haile, USA • Tobin J. Marks, USA • Daniel G. Nocera, USA • Yang Shao-Horn, USA • Licheng Sun, Sweden • Jean-Marie Tarascon, France For full details on Challenges in Chemical Renewable Energy (ISACS12), please visit the event webpage.
At Organic Process Research & Development Conference, you will hear detailed presentations and case studies from top international chemists. Our hand-picked programme of speakers has been put together specifically for an industrial audience. They will discuss the latest issues relating to synthetic route design, development and optimisation in the pharmaceutical, fine chemical and allied fields.
This new international conference and exhibition has been designed to showcase synthetic chemistry involving hazardous reagents, intermediates and / or reaction conditions carried out on an industrial scale. Safety aspects and changes to reaction conditions to avoid dangerous operating conditions will be highlighted. The conference will include examples involving azide and diazo chemistry, peroxygen compounds, hazardous sulphur compounds such as DAST and related reagents, pressure reactions such as carbonylations, halogenations, nitrations and nitro-compounds, organometallic chemistry, hydride reductions presented by industrial speakers from around the world.
The 4th ICM 2013 plans to shoot for 300+ oral presentations in life sciences of medicinal chemistry, practical hot-topics of medichem, small molecule drugs R & D against major diseases from industrial executives, academic professors, investors, marketing people and governmental policymakers from 50+ countries. Also, the annual will also include diversified workshops, business development forums, career fairs, training courses, poster sessions, matchmaking activities, award ceremony, university seminars, industrial park field trips and post-conference tech tour etc. ICM-2013 will be an ideal meeting place for you to share the philosophy of bio/ pharmaceutical professionals help professionals. It’s our great pleasure to bring the best people together in one single place to share latest medicinal chemistry information so as to accelerate your drug discovery & development process. As a branded Conference of our company to be "Your Think Tank", ICM continues to expand with newly designed magnificent scientific and social programs to maximize your network and partner hunting in a free communication meeting environment.