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Overview: Many infectious diseases were historically confined to specific geographical regions. However, some now pose global threats due to ease of travel, globalization of trade and commerce and global warming. Government Agencies, non-Profit Organizations, Philanthropic groups and others are also funding vaccination programs for regions where infectious diseases are endemic and to deal with new outbreaks.. Such developments are stimulating research in and the development of improved vaccines, their manufacture and control. Supply Chain complexities and stability issues need to be addressed to cope with transport of vaccines to and their use in climatically hostile regions. Programs to address such challenges need to be implemented, being resourced by appropriately trained and qualified staff from a number of disciplines. Development programs for immuno oncology products also require staffing by similarly skilled professionals. Workers currently engaged in Discovery, Development and Manufacture of conventional medications , or those seeking career-change opportunities can develop an understanding of the concepts, constraints and opportunities associated with Vaccine products by attendance at the Webinar. Engineering professionals involved in facility construction, or repurposing can also benefit as can Regulatory Affairs Professionals or staff at medicines Evaluation Agencies. The subject matter is particularly suited to professionals who are expert in the various disciplines associated with conventional medications ("so-called "small molecules") who wish to expand and develop their skills by involvement in vaccine-related programs including immuno-oncology. Areas Covered in the Session: History of and development of vaccine concepts. undamentals of vaccination Vaccine Types Administration of Vaccines Future Concepts Immuno-Oncology Vaccine Manufacture Who Will Benefit: Regulatory Affair Managers Project Management Personnel QA Managers Scientists Technol

Course "Risk Analysis and Design of Experiments (DOE) in Process Validation and Development" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion. Overview: This course is designed to help scientists and engineers plan and conduct experiments and analyze the data to develop predictive models used to optimize processes and products and solve complex problems. DOE is an extremely efficient method to understand which variables (and interactions) affect key outcomes and allows the development of mathematical models used to optimize process and product performance. The models also provide an understanding of the impact of variability in controllable and uncontrollable factors on important responses. The concepts behind DOE are covered along with some effective types of screening experiments. Case studies will also be presented to illustrate the use of the methods. This highly interactive course will allow participants the opportunity to practice applying DOE techniques with various data sets. The objective is to provide participants with the key tools and knowledge to be able to apply the methods effectively in their process and product development efforts. Why should you attend: · Plan and conduct experiments in an effective and efficient manner · Apply good experimental practices when conducting studies · Determine statistical significance of main and interaction effects · Interpret significant main and interaction effects · Develop predictive models to explain and optimize process/product behavior · Check models for validity · Utilize models for one or more responses to find optimal solutions · Apply very efficient fractional factorial designs in screening experiments · Apply response surface designs for

Overview: One of the major requirements of the health care organization to be HIPAA compliant is to develop and implement a set of HIPAA privacy and security policies and procedures. This can be a daunting task for those not knowing where to start and what a set of HIPAA privacy and security policies and procedures should look like. For the cost conscious health care organization, the HIPAA policies and procedures can have multiple uses: first, they can become a basis for training the health care organization workforce; second, they can be used as a basis for conducting a HIPAA self-assessment; and third, they can be used to demonstrate due diligence should there be a breach or an externalHIPAA compliance audit. In today's world it is not necessary that the health care organization spend significant funds to develop a set of HIPAA privacy and security policies and procedures from scratch. The health care organization can likely find templates on the internet that can be used as a starting point to customize HIPAA policies and procedures to be unique for the health care organization. The preparation of a well-documented set of HIPAA policies and procedures needs to be addressed through the development of Privacy and Security policies and procedures that address each of the requirements shown in the HIPAA regulations as amended by the HITECH law and the final Omnibus Regulations. The process of developing the HIPAA privacy and security policies and procedures also provides a reference for the health care organization how to consider the security addressable and required regulation requirements. Why should you attend: There are three situations where having a set of HIPAA policies and procedures are needed: First, the policies and procedures become a good reference to ensure that all areas are addressed for becoming HIPAA compliant. Second, the HIPAA regulations REQUIRE covered entities and business associates to have a set of policies and procedures directing t

Shingles is a type of skin infection that is mainly caused by the reactivation of herpes zoster or chickenpox virus. Two vaccines till now have proven successful at reducing the chances of developing shingles. One is, Zostavax, which consists of a bigger-than-usual dose of the chickenpox vaccine since shingles and chickenpox are caused by the same virus, the varicella virus. The other vaccine is called Shinglesvax, consists of an adult shingles vaccine which has been proven to be effective in preventing younger children and adults from developing shingles. If someone develops shingles after receiving either of these, they need a varicella immune globulin vaccine. The shingles vaccine is made from a weakened chickenpox virus and when used in combination with symptoms specific to shingles, it greatly reduces the risks of developing the infection. However, there is a possibility of developing more serious side effects such as a rash or muscle pain. Rare side effects include feeling faint, nausea, blurred vision, and chest pain. The factor driving the growth of the shingles vaccine market is the increased prevalence of shingles worldwide. Moreover, the rising geriatric population and the high number of launches and approval of shingle vaccines are also estimated to trigger the market growth. For instance, in August 2019, experts from the Université Laval, Québec, and Centre de research du Centre Hospitalier de l'Université de Québec found that the Shingrix vaccine developed by GSK is very effective in terms of cost and treatment than the Zostavax developed by Merck & Co. The overall effectiveness of the vaccine was 97% and has a higher effectiveness rate among the geriatric population. Shingrix right now is the main competitor of Zostavax in the market. Read more @ https://coherentmarketinsights-blog.blogspot.com/2021/01/the-global-shingles-vaccine-market.html

Overview: One of the major requirements of the health care organization to be HIPAA compliant is to develop and implement a set of HIPAA privacy and security policies and procedures. This can be a daunting task for those not knowing where to start and what a set of HIPAA privacy and security policies and procedures should look like. For the cost conscious health care organization, the HIPAA policies and procedures can have multiple uses: first, they can become a basis for training the health care organization workforce; second, they can be used as a basis for conducting a HIPAA self-assessment; and third, they can be used to demonstrate due diligence should there be a breach or an externalHIPAA compliance audit. In today's world it is not necessary that the health care organization spend significant funds to develop a set of HIPAA privacy and security policies and procedures from scratch. The health care organization can likely find templates on the internet that can be used as a starting point to customize HIPAA policies and procedures to be unique for the health care organization. The preparation of a well-documented set of HIPAA policies and procedures needs to be addressed through the development of Privacy and Security policies and procedures that address each of the requirements shown in the HIPAA regulations as amended by the HITECH law and the final Omnibus Regulations. The process of developing the HIPAA privacy and security policies and procedures also provides a reference for the health care organization how to consider the security addressable and required regulation requirements. Why should you attend: There are three situations where having a set of HIPAA policies and procedures are needed: First, the policies and procedures become a good reference to ensure that all areas are addressed for becoming HIPAA compliant. Second, the HIPAA regulations REQUIRE covered entities and business associates to have a set of policies and procedures directing

Hybrid seeds are developed by cross-breeding plants (two or more plants) of different species. Cross-pollinated will develop a seed that carries one or more desired traits. These seeds are widely used in farming (commercial) to increase yields and to develop climate and disease resistant plants. Moreover, these seeds are widely used in farming and gardening of vegetables and flowers such as sweet corn tomatoes, and roses. Hybrids are chosen to improve the characteristics of the resulting plants such as better fruit quality, better uniformity, heat and cold tolerance, early maturity, increased yield, etc. Increasing demand for vegetables and fruits from emerging economies is expected to increase the demand for hybrid seeds. Hybrid seeds are the major contributors to the rise in agricultural output since the 20th century. Several breeding companies are focused on developing the resultant crops resistant to diseases through extensive research and development activities. However, the development of such seeds may be hindered under adverse climatic conditions. In 2018, a German company launched a hybrid rice seed with robust tolerance to Brown Plant Hopper pests and Bacterial Leaf Blight. Read more @ https://coherentmarketinsights-cmi.blogspot.com/2020/12/hybrid-seeds-increase-yields-and.html

Overview: Upon completing this course participants will leave with a preliminary preventive control implementation plan and will: * Understand US FDA final rules for the Preventive Controls for Human and Animal Foods * Define and review your current system to identify gaps in your preventive controls planning. * Be able to develop and implement a valid preventive control company food safety plan to close any gaps * Write and implement appropriate procedures. * Know your requirements for control over your supply chain * Be able to plan and implement HARPC * Be able to perform environmental monitoring * Know how cross contamination can impact your preventive control plan * Know the difference between validation and verification * Understand and be able to use statistical process controls basics * Be able to plan and implement a team approach to preventive controls * Be able to help your food importers to jump through FDA hoops * Develop a system to risk rank your suppliers * Have a plan in hand that will pass any validation check for preventive controls * Understand some of the technology and costs that can help you establish preventive controls * Prove that your system actually prevents food safety problems * Be able to document and report results to upper management, external food safety auditors and FDA auditors * Save your company money Establish simple, low cost complete data collection and reporting systems. * Establish teambuilding between food safety and quality personnel to develop and implement changes to your current system * Understand food safety, security and recall responsibilities in light of cargo theft, adulteration and temperature failures * Learn how to use your system to get some ROI and improve your marketing position * Review current and future technologies designed to improve and simplify data collection * Establish a completely documented system Why should you attend: Validation of preventive co

Overview: The presentation takes the participant through the steps needed to ensure a successful health care computer system implementation. Once presented the participant will see the logic of the tools and processes and be able to apply them to their system implementation. The tools and processes presented in this material have been developed by implementing health care systems for over 40 years and seeing what has worked and WHY it has worked. These tools and processes have been equally and successfully applied to the implementation of large, complex systems and smaller, simpler systems for large, multidepartment organizations and for small health care organizations. The process focuses on establishing the project's implementation expectations, identifying meaningful metrics for success, establishing project plans, assigning individual accountabilities and responsibilities, establishing and executing project tasks, monitoring project progress and validating project success. To establish viable project expectations, the presentation addresses the need for bringing all of the stakeholders (organization owners, providers and management, operations staff, IT staff and the vendor) into establishing common and realizable expectations. These are reviewed in context of the organization's current environment and its short and long term goals and are considered as a critical part of the implementation completion process. In the case of turning around an already troubled or failed system implementation, the process emphasizes the tasks of reassessing the project stakeholder expectations - why they decided the system would help the organization and what they expected to get from the system. Next the process shows the participant how to convert these expectations to realistic and measurable project success metrics. The process focuses on learning how to separate "so what" metrics from meaningful and measurable metrics. In addition, the process provides direction regardin

Course "Key Factors to Write an Effective Standard Operating Procedure (SOP) and Work Instructions (WIs)" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion. Overview: Writing SOPs or procedural documents can be challenging at times. However, writing SOPs is overall a straightforward process. However, enforcing what you already created and implemented in the pipeline is another story. The term SOP is very obvious. We have seen "clearly written description of how specific tasks are to be done." Another satisfactory definition would be "detailed written instructions that achieve the uniformity of the performance of a specific function." Is the firm doing what the regulations specify? Is the firm doing what their procedures specify? If you are medical device or a pharmaceutical manufacturer, these definitions come as no surprise because when it comes to FDA regulations and guidance documents "establish" means to define, to document (in writing or electronically) and to implement. The goal and emphasis with FDA is simple. Proof of "Establish" is the foundation. Is the firm doing what the regulations specify? Is the firm doing what their procedures specify? Are the procedures being followed and enforced by company personnel? SOPs are needed in regulated industries to give step-by-step instructions for performing a particular job or task. This session will provide a step-by-step overview and a snapshot of the procedure description, the process and format. The subject matter of a SOP may range from how to operate a piece of machinery to how to log into a particular software program. SOPs ensure consistency and reliability because they require training of all affected parties. This session will address recent enforcement actions for SOP related violations but no surprise. Most of our enforcement actions are documentation related, i.e., SOP or other procedural documents. We will review examples from

Seminar on Analytical Instrument Qualification and Validation: Understanding to Prepare for FDA Audits to become Part 11 Compliant at Boston, MA Course "Analytical Instrument Qualification and Validation: Understanding to Prepare for FDA Audits to become Part 11 Compliant" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion. Overview: In this two day workshop conference you will learn the different global agencies expectations of analytical equipment qualification along with the development of a sound process validation program in order to develop and implement bulletproof solutions that are accepted, effective, and efficient. Through case study analysis we will examine best practices to provide thoughts and ideas to develop or improve the performance of your current system. Additionally, case studies will explore how your management practices of your analytical equipment qualification/ validation and process validation programs can help or hurt your legal liability and the legal issues that arise from nonconformance with regulators and Auditors. This seminar will help attendees understand the instrument qualification and system validation processes and will provide instruction on how to prepare for FDA audits and how to become part 11 compliant. Why should you attend? The cost of non-compliance is therefore more than that of compliance. Are you in compliance with the FDA regulations for analytical equipment qualification and validation in your facility? Areas Covered in the Session: * Learn about the regulatory background and requirements for laboratory instrument qualification and system validation * Understand the logic and principles of instrument qualification and system validation from validation planning reporting * Understand and be able to explain your company's qualification and validation strategies * Be able to independently prepare execute test protocols, this includes s

Ensuring Patient Safety in Surgical Environments is Critical for Healthcare Providers A critical component of patient safety relates to surgical environments. Surgical theaters are prone to causing a high degree of harm. This can be from a number of sources. Patient safety in surgical environments can be from any microbe or fungus in any of the accessories used during surgery, such as ECG machine, the echo machine, or other related ones. A host of external factors can impinge upon patient safety in surgical environments Patient safety in surgical environments can also be compromised on account of the use of infected items such as swabs, sponges, knives, forceps, needles, catheters, tubes or any other such accessories or instruments. Patient safety in surgical environments can also get affected by the presence of microscopic allergens and molds in any bedding or clothing item. Even germs transmitted from the caregivers can be a source of lack of patient safety in surgical environments. Another major source where patient safety in surgical environments can suffer is when items are left behind in patients��� bodies by the surgeon. There have been innumerable cases of entire surgical items being left behind in the patient, even in the best hospitals, when surgery is performed by the best surgeons. Get a proper understanding of the underlying causes What do all these point to? These point to the fact that all the factors mentioned above are manmade and are preventable. So, understanding the root of the problem is the key to ensuring patient safety in surgical environments. East and west carry differences Any approach to a solution for ensuring patient safety in surgical environments has to start with the understanding that different healthcare and surgical environments exist in different parts of the world. A surgical environment in Germany for instance is vastly different from that in say, Ghana. So, an individualized approach is what is needed. It is to be note

Medical Informatics is a story of phenomenal growth: Medical informatics is an area that is growing at a fervid pace. Its growth is not likely to get hindered or slow down in the near future, due to the surge in its use in the healthcare and IT industries. Medical Informatics is a relatively recent development in the field of healthcare. It is interwoven into the development and application of IT-based innovations in the healthcare industry. Medical informatics is often synonymously and loosely used with other related words such as clinical informatics, nursing informatics, healthcare informatics and so on. Its associations with related or similar disciplines notwithstanding, one can draw a fairly clear idea of medical informatics. It can be described as the application, adoption, design and development of IT into activities relating to the healthcare industry. What is the objective of medical informatics? Medical informatics seeks to enhance knowledge and innovate in the healthcare field by using IT and its applications. Towards this end, it uses and merges the principles, knowledge, data, application, and the tools needed for applying these in the process of decision-making. Who are involved in the use of medical informatics? Medical informatics is used by almost everyone in the healthcare industry. These include physicians, nurses, billers, coders, many others who provide healthcare, and medical librarians. In addition, there are specialists who are tasked purely with working with medical informatics, such as Data analysts Hospital record managers, and Programmers and analysts in the industry. The rise and rise of medical informatics The birth and growth of medical informatics has been tied to those of the IT industry, the Internet in particular. In a sense, they are twins, having started and grown in almost a conjoined fashion. Its early development started in the 1960s, very nearly contemporaneous with that of the Net. While the medium that brought

Medical Informatics : Medical informatics is an area that is growing at a fervid pace. Its growth is not likely to get hindered or slow down in the near future, due to the surge in its use in the healthcare and IT industries. Medical Informatics is a relatively recent development in the field of healthcare. It is interwoven into the development and application of IT-based innovations in the healthcare industry. Medical informatics is often synonymously and loosely used with other related words such as clinical informatics, nursing informatics, healthcare informatics and so on. Its associations with related or similar disciplines notwithstanding, one can draw a fairly clear idea of medical informatics. It can be described as the application, adoption, design and development of IT into activities relating to the healthcare industry. What is the objective of medical informatics? Medical informatics seeks to enhance knowledge and innovate in the healthcare field by using IT and its applications. Towards this end, it uses and merges the principles, knowledge, data, application, and the tools needed for applying these in the process of decision-making. Who are involved in the use of medical informatics? Medical informatics is used by almost everyone in the healthcare industry. These include physicians, nurses, billers, coders, many others who provide healthcare, and medical librarians. In addition, there are specialists who are tasked purely with working with medical informatics, such as Data analysts Hospital record managers, and Programmers and analysts in the industry. The rise and rise of medical informatics: The birth and growth of medical informatics has been tied to those of the IT industry, the Internet in particular. In a sense, they are twins, having started and grown in almost a conjoined fashion. Its early development started in the 1960s, very nearly contemporaneous with that of the Net. While the medium that brought it into existenc