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This unique 3 day course is designed to integrate the key elements of tablet development with hands-on, practical experience in a small scale, lab scale test facility. Each day will consist of lectures on aspects of tablet development, followed by linked sessions in which participants take part in related experimental work. The course enables attendees to apply the theory learnt in the taught sessions, and also to directly observe the effect of formulation on product properties, and relate the theory to the practice of Quality by Design (QbD). Who Should Attend? * Newcomers to tablet formulation development and manufacturing * Production operators who need a better understanding of their products and how they have been developed * Analytical and QC staff who would benefit from understanding the tablet development and production process * Experienced personnel in one area of product development who need a broader overview * Project team members needing a broader insight into formulation development including preclinical, clinical, and project management representatives * Regulatory staff who would benefit from brief practical experience of the processes for which they are compiling dossiers. Regulatory agency staff requiring practical experience Numbers are restricted to 10 participants for maximum benefit Learning outcomes * Understanding of the relationship between Quality by Design, drug substance properties, formulation and process development * Practical experience of small scale tablet manufacture with direct knowledge of the relationship between formulation properties and tablet compressibility * Understanding of the roles of critical quality attributes, critical process parameters, and product control strategy in the application of the principles of QbD to formulation development
Regulatory Agencies require written procedures for all systems and operations which impact the quality and safety of pharmaceutical products. Standard Operating Procedures (SOP’s) provide the main forum for the documentation of a Company’s systems and operations. SOP’s are therefore the most popular documents audited by Regulatory Agencies during GMP inspections and all too often they result in observations. . This course provides helpful information by presenting topics associated with the writing, formatting, execution and management of SOP’s that contribute to consistent and efficient operations. It also discusses good documentation practices required by companies to ensure GMP compliance and relates the role which SOP’s play in achieving the required level of compliance and quality. This course is designed to assist with writing effective SOPs which contribute to the overall compliance of a company. What regulatory inspectors look for in SOPs, Good Documentation Practices, Global Harmonization of SOPs and maintenance of the SOP system though change control are also discussed. * Regulatory inspectors expectations for SOPs * The role of SOP’s with respect to GMP operations, global harmonization, documentation and document control. * Good Documentation Practices * Reviewing current SOP’s to determine gaps and overlaps to strengthen the existing documentation system. * Maintenance of SOPs Designing an SOP template to optimize efficiency of organization and formatting of SOP’s The team approach to SOP writing, defining responsibilities and knowing the audience. The importance of capturing the actual flow of an operation within the document Writing tips on how to keep the document concise, unambiguous and accurate. Training of SOP documents Managing revisions and deviations through a document Change Control System
Validated processes can often fail during the transfer stage and result in non-value added investment of resources to troubleshoot the problems. Two main reasons for this are; either the variables which contribute to inconsistencies of the outcome of the procedure have not been identified or controlled adequately or the transfer of knowledge of the process has not been performed effectively. Whatever the process may be identifying, understanding and controlling variables is a key strategy towards enabling the process to perform to give a consistent outcome during routine use. In the event the process has to be transferred to a new environment, effective knowledge transfer of the process is vital to success. There are many courses available today which cover the quality by design approach to developing manufacturing processes and analytical procedures so why should you attend this workshop? A process is a process and this one day practical workshop provides the opportunity to learn and apply the basic skills required to investigate, identify and understand variables, to develop a consistent process and transfer the knowledge of that process successfully. Participants will have the opportunity to use quality by design tools and concepts such as the target profile, risk assessment and control strategy to develop a simple process through experimentation and data analysis and then communicate it effectively to others. The skill set and mindset experienced during the classroom team exercises will provide a solid foundation when dealing with industry processes This workshop was designed to provide hands on experience using QbD tools and concepts such as the target profile, risk assessment and control strategy by applying them in the design and development of a simple process. This is achieved through experimentation with a statapult and/or making “Tasty Tablets”. The actual classroom process(s) will depend on the number and the background of attendees.
Drug Discovery Chemistry is a dynamic conference for medicinal chemists working in pharma and biotech. Focused on discovery and optimization challenges of small molecule drug candidates, this event provides many exciting opportunities for scientists to create a unique program according to personal interests. New this year is Epigenetic Inhibitor Discovery which nicely complements the most popular topics from previous years: Anti-Inflammatories, Protein-Protein Interactions, Macrocyclics and Constrained Peptides, Fragment-Based Drug Discovery, and Kinase Inhibitor Chemistry. Please browse through this website to see how our great lineup of speakers and synergistic topics come together to create the leading drug discovery chemistry event.
he 3rd AGRI-net International Plant Chemical Biology conference aims to stimulate collaborations between the chemical biology and agri-science research communities drawn from academia and industry. This one day meeting provides a forum for the exchange of ideas and approaches to tackle challenges in sustaining and protecting food and fibre production. Taking place on the 16th of May 2014 at Syngenta’s International Research Centre, this meeting will cover a wide spectrum of research, with poster contributions from both, the chemical biology and agri-sciences communities. If you are interested in attending this meeting and/or presenting your research in the form of an oral or poster presentation please visit our website: www.agri-net.net. Registration closes 30th of April. Registration is FREE but places are LIMITED. Call for Posters: Posters are invited for display throughout the meeting. A small number of poster presenters will be invited to present a short talk on their research. Programme: We are thrilled to announce the following speakers have confirmed to speak at conference: Pietro Spanu - Imperial College London, UK Davey Jones - Bangor University, UK Angela Karp - Rothamsted Research, UK Richard Napier - University of Warwick, UK
The reproducible production of organic crystals in the correct form (habit, solvate, polymorph) and particle size is a source of much heart-ache. Although production of new polymorphs and solvates can be a source of profit for companies through extension of the patent lifetime, the inability to manufacture a consistent crystalline form often leads to costly project delays, particularly in chemical development. This conference will focus on these issues from the viewpoint of the process chemist and chemical engineer; i.e. on chemical development issues which impact the ability to routinely manufacture the chosen crystalline form, whether this be the most stable or a metastable crystal. Case studies from different companies will show how different organisations identify and solve these extremely difficult issues in different ways, depending on how far the project is along the development time line. Experts in the field will also give lectures on problem solving and troubleshooting, as well as giving insight into new techniques, (supercritical fluids, polymorph prediction etc.) which will be of value in the future.
This 3-day conference and exhibition has been designed to fill a gap in the conference field, providing a forum where industry and academia can meet to discuss new synthetic methodology and chiral chemistry, and how practical this methodology is from an industrial viewpoint. Industry rarely devises new synthetic methods to perform each step in the synthetic route but relies on using and modifying methods which have been discovered within academia. It is therefore essential that the industrial chemist, whether in early research and discovery or process chemistry, is aware of the latest developments in synthetic organic chemistry, so that efficient and practical methods for synthesising new molecules are devised. Emphasis will be on the state of the art and will provide directions for future work. Industrial chemical case studies where key reactions have been used, either in discovery or in development, will be provided. This conference is being sponsored by Umicore and will feature a special session on Metathesis. More information to follow. The conference proceedings for the event will contain all the lecture presentations with key references to the current literature and will provide a valuable source of data for the future.
As a must-attend event for senior medicinal chemists, we invite you to join us for inspiring discussions on the future role of medicinal chemistry and its contribution to improved drug discovery rates.
This course has been updated to reflect the recent changes in the pharmaceutical stability testing world. The new course content will provide a comprehensive update on current trends which offer substantial potential savings in time and resources in a traditionally costly testing area. It will include opportunities for review of specific participant problems The course will cover: * Recent regulatory changes affecting stability including * The implications of implementation of ICH Q7, Q8, Q9, Q10 and Q11 for stability testing * Changes to European GMP guidance with impact on stability testing including Annexe updates affecting product development, outsourcing and application of Quality Risk Management (QRM) * Product Quality Reviews and the interpretation of stability data. Recent scientific developments with implications for stability, with a particular focus on cost reduction, shortening of development timelines, and improvements on existing interpretation systems * ASAP - using short term high stress testing to get accurate predictions of shelf life with a high degree of confidence – Freethink Technologies’ ASAPprime® * Low level impurities and their impact on product stability * Manipulation of tablet internal pH to improve product stability
Analytical methods must be validated to provide reliable data for regulatory submissions. These methods are essential for a number of purposes, including testing for QC release, testing of stability samples, testing of reference materials and to provide data to support specifications. This course provides a comprehensive coverage of the method development and validation requirements that are essential to progress a pharmaceutical compound, at each stage of product development. Upon completion of this course, delegates will have learned what is necessary to develop and validate methods for drug substance and drug product to comply with international regulatory guidelines. The course is designed for Scientists working with HPLC who need to further their understanding of the technique in order to develop better methods faster. Scientists who have to validate HPLC methods in accordance with current internationally-accepted guidance. HPLC technicians working in R&D laboratories, quality control laboratories and stability testing laboratories. Managers with a responsibility for generating regulatory submissions.
A Stability Indicating Method (SIM) is defined as a validated analytical procedure that accurately and precisely measures active ingredients (drug substance or drug product) free from process impurities, excipients and degradation products. High Performance Liquid Chromatography (HPLC) is the favoured method of detecting possible degradants and impurities. Analytical methods must be validated to provide reliable data for regulatory submissions. These methods are essential for a number of purposes, including testing for QC release, testing of stability samples, testing of reference materials and to provide data to support specifications. This course provides a comprehensive coverage of the method development and validation requirements that are essential to progress a pharmaceutical compound, at each stage of product development. Upon completion of this course, delegates will have learned what is necessary to develop and validate methods for drug substance and drug product to comply with international regulatory guidelines. Who Should Attend? Scientists working with HPLC who need to further their understanding of the technique in order to develop better methods faster. Scientists who have to validate HPLC methods in accordance with current internationally-accepted guidance. HPLC technicians working in R&D laboratories, quality control laboratories and stability testing laboratories. Managers with a responsibility for generating regulatory submissions .
This interactive workshop provides up-to-date, relevant and detailed information on the impact of Quality by Design (QbD) on the Development and Validation of tablet manufacturing processes. It will also study the identification and evaluation of Critical Product Attributes and Critical Process Parameters for tablets, and their implications for process control. We develop new concepts including the use of risk and process matrices for risk management. The latest ICH and FDA guidance on Quality by Design and Process Development, published in 2009, will be comprehensively reviewed. By the end of the course, you will * Understand the relationship between the principles of QbD and tablet development and process validation in generic and new product development * Understand the relationship between material properties, formulation development and process development * Understand the processes commonly used to manufacture tablets and the factors which affect them Recognise how to identify critical processing parameters, and how to incorporate into a process validation program * Understand the principles of PAT, how and where it can be most effectively deployed * Know the latest FDA thinking on Process Development including the three key steps of validation . Who should attend? The course is designed for people new to Process Development, and those requiring a refresher in the area. It will also benefit Process Development experts wishing to extend their understanding of why products processes can go wrong, and regulatory and quality personnel who need to understand the development process better. The course will include the latest FDA guidance on the development of generic products under QbD.
Whether you are chemist, chemical engineer, QA or safety specialist, your aims when scaling up your process are often 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 presenting 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. Key Topics will include: QbD, DoE and CSTRs.
5th International Conference and Exhibition on Analytical and Bioanalytical Techniques during August 18-20, 2014 at DoubleTree by Hilton Beijing, China. The conference will focus on "Critical review on recent developments in analytical and bioanalytical techniques"
Do you want to improve efficiency and innovation in your synthetic route design, development and optimisation? The efficient conversion of a chemical process into a process for manufacture on tonnage scale has always been of importance in the chemical and pharmaceutical industries. However, in the current economic and regulatory climate, it has become increasingly vital and challenging to do so efficiently. 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. Unlike other conferences, practically all our speakers are experts from industry, which means the ideas and information you take home will be directly applicable to your own work. The smaller numbers at our conferences create a more intimate atmosphere. You will enjoy plenty of opportunities to meet and network with speakers and fellow attendees during the reception, sit-down lunches and extended coffee breaks in a relaxed and informal environment. Together, you can explore the different strategies and tactics evolving to meet today’s challenges.
Formerly know as Developing Active Pharamceutical Ingredients, this conference tailored for the Asian process chemistry community has been developed from the popular and influential international conference on "Organic Process Research and Development". This conference will feature a mix of international and local presenters who will provide a forum for the discussion of issues related to synthetic route design, development, optimisation and scale-up. The conference will contain a variety of industrial presentations, selected to emphasise their companies' approach to these issues, with case studies in the development of new processes.
The 2nd Winter Process Conference will consist of presentations from international chemists, chemical engineers and biotechnologists covering all aspects of Process Development. process-chemistryThe speakers will discuss the latest issues in synthetic route design, development and optimisation, reactor design, work up and purification, crystallisation, biocatalysis, and quality and regulatory issues. The presentations will be from either speakers within the chemical industry or academics with a strong link to industrial process development, so the material presented will be of particular relevance to all chemists and biochemists in industry, as well as graduate students considering a career in industry.