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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

Overview: Today's educated professionals function in a maze of different educational and training requirements, which vary from state to state and from profession to profession. Nowhere than in health care is this more evident where multidisciplinary health care practitioners work together towards a common goal for the patient. What is a profession? What areas of work require the unique professional education, training, and experience that becomes mandated by the state? What work requires professional judgment and skill so as to be regulated by the government through mandatory laws applicable to an individual person practicing his or her chosen profession? State laws are enacted for the protection of the public by legislatures in all the fifty states. A list of individual professions and their applicable statues and administrative regulations takes up entire volumes of lawbooks. These state laws impose significant regulation on these professionals, and often in very different ways found in many aspects of state regulation, from the educational process, the examination requirements, the state licensure applications, and the legal standards and rules of each unique profession. Explore how state licensure boards are created and function at the state level. While most such state agencies have common, core functions and operations, there are many differences - and some requirements that are truly the opposite from profession to profession. Review the common requirements the state imposes on the health care provider. Know the basics of professional education and licensure. Understand the difference between legally binding laws and mere codes of ethics, which are aspirational and do not form the basis for legal action. Find out how to understand and navigate the challenges presented from differing and conflicting state laws governing the many health care professions. Know where key requirements exist that are common to many professions. This program offers an obje

Course "Validation and 21 CFR 11 Compliance of Computer Systems: Intermediate to Advanced" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion. Overview: Computer Systems Validation (CSV) also known as Software Validation is all-pervasive in the Life Sciences Industry. It is a requirement of all the predicate rules, as well as 21 CFR 11 and Annex 11. However, unless one knows how to implement CSV, it is often very hard to detect the requirement for CSV, and very hard to determine what needs to be done, to meet domestic and / or international regulations or business continuity requirements. In addition, the FDA has stepped up 21 CFR 11 inspections that include CSV. This course will build on the Validation and 21 CFR 11 Compliance Basic Course, to give hands on experience on executing on the computer systems validation of a system, and to discuss related activities such as Validation Master Plan, Infrastructure Qualification, Project Management for Validation and Validation of Test Tools The attendees must have attended the Basic Validation & 21 CFR 11 Compliance. This is a very hands-on class and the attendees will be expected to use templates provided in the class to create the complete package for the validation of a system The Seminar: This Hands-On course will provide the attendees with more detailed experience on validation / 21 CFR 11 compliance of a computer system, as well as details for activities associated with computer systems validation as follows: 1. Validation Master Plan 2. Complete Validation for a System 3. Excel Spreadsheet Validation 4. Change Control 5. SOPs 6. Test Tools Validation 7. Project Management for Validation Who Should Attend : * VP of IT * Director of IT * Quality Managers * Project Managers (for CSV / IT) * Validation Specialists * Database Administrators * System Administrators * Directors / Senior Directors of Discovery * Directors /

Course "Validation and 21 CFR 11 Compliance of Computer Systems: Intermediate to Advanced" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion. Overview: Computer Systems Validation (CSV) also known as Software Validation is all-pervasive in the Life Sciences Industry. It is a requirement of all the predicate rules, as well as 21 CFR 11 and Annex 11. However, unless one knows how to implement CSV, it is often very hard to detect the requirement for CSV, and very hard to determine what needs to be done, to meet domestic and / or international regulations or business continuity requirements. In addition, the FDA has stepped up 21 CFR 11 inspections that include CSV. This course will build on the Validation and 21 CFR 11 Compliance Basic Course, to give hands on experience on executing on the computer systems validation of a system, and to discuss related activities such as Validation Master Plan, Infrastructure Qualification, Project Management for Validation and Validation of Test Tools The attendees must have attended the Basic Validation & 21 CFR 11 Compliance. This is a very hands-on class and the attendees will be expected to use templates provided in the class to create the complete package for the validation of a system The Seminar: This Hands-On course will provide the attendees with more detailed experience on validation / 21 CFR 11 compliance of a computer system, as well as details for activities associated with computer systems validation as follows: 1. Validation Master Plan 2. Complete Validation for a System 3. Excel Spreadsheet Validation 4. Change Control 5. SOPs 6. Test Tools Validation 7. Project Management for Validation Who Should Attend: * VP of IT * Director of IT * Quality Managers * Project Managers (for CSV / IT) * Validation Specialists * Database Administrators * System Administrators * Directors / Senior Directors of Discovery * Directors / Senior

The human microbiome is comprised of archaea, eukaryotes, bacteria, and viruses that reside within anatomical sites of the human body including skin, placenta, uterus, mammary glands, lung, saliva, oral mucus, etc. There have been various attempts at understanding the mechanism of this microbiome. The U.S. National Institutes of Health (NIH) launched 'The Human Microbiome Project' to enhance the understanding of microbial flora that is involved in human health and disease. The goals of the project were to reveal the diversity of the microbial community in healthy people, to assess the impact of the environment on the microbiomes of individuals, and to identify new applications for these microbes. The microorganisms in human bodies are an important part of a balanced natural system. This project is a collection of over 100 human microbiomes that was obtained from healthy individuals of the U.S. This reference panel was then compared with the microbiomes from the same individuals' stool samples. Read More @ https://coherentmarketinsights-cmi.blogspot.com/2020/11/human-microbiome-project-is-gaining.html

The digital genome consists of a complete digital collection of DNA material that occurs within an organism or a cell. It's a simpler method to collect genetic data concerning hereditary disorders and is used extensively by geneticists for a closer look at potential genetic illnesses. It was first intended to be a tool of diagnosis but has evolved into a powerful research tool. The growing popularity of the human genome projects is a prime factor fueling the growth of the digital genome market. According to Forbes, by 2025, it's projected that 100 million genomes will be sequenced. Increasing funding for genomics is another major factor in augmenting market growth. Moreover, growing development in the field of biotechnology due to rising healthcare needs and increasing investment by the government is again driving the market growth. Additionally, the growing demand for personalized medicines coupled with the penetration of new players and start-ups across developing economies is also projected to foster market growth. Furthermore, the increasing prevalence of chronic disease is further projected to propel the growth of the digital genome market. Read more @ https://coherentmarketinsights-blog.blogspot.com/2021/01/digital-genome-powerful-tool-for.html

Course "Verification vs. Validation - Product Process Software and QMS" 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 will review the company Master Validation Plan for major key inputs and CGMP deficiencies. It will address the FDA's newer and tougher regulatory stance. This course's aim is to prove "Product Risk Based V&V" by sufficient, targeted and documented risk-based V&V test case elements/scripts. It will teach participants to evaluate its elements against ISO 14971 and ICH Q9 for hazard analysis and product risk management. This course will evaluate different field-tested, U.S. FDA-reviewed V&V protocols; how to employ equipment/process Requirements Specs / DQs, IQs, OQs, and PQs, or their equivalents per ASTM E2500, all against a background of limited company resources. It will review a matrix that simplifies "as-product", in-product", process and equipment, et al, software VT&V, to assure key FDA requirements are not overlooked. While considering the QMS and 21 CFR Part 11; this course will make practical application of these same in two hands-on sessions. Why you should attend: This session helps participants: * Understand Verification and Validation, differences and how they work together; * Discuss recent regulatory expectations; * Know how to document a "risk-based" rationale, and use it in a resource-constrained environment; * Determine key "milestones" and "tasks" in a project; * Locate and document key subject "inputs"; * Compile "generic" Master and Individual Validation Plans; * Learn the key element of a Product V&V File/Protocol; * Understand how to develop Process and/or Production/Test Equipment V&V Files/Protocols; * Get a grasp of basic Test Case construction; * Understand sample sizes and their justification; * Learn the key elements of Software V&V expected by the FDA and how to document; * Deal with hardwa

Alkaline proteases are a type of enzyme that is active from neutral to pH range. An enzyme is any living thing that can be defined as a chemical reaction that changes something else, usually making a change in its shape or composition at some point during the catalytic reaction. The catalytic reaction may be a kinetic one - that is, it changes something because of the energy produced - or it may be a metabolic one - that is, it changes something because of the energy available for the catalytic reaction. Basically, an enzyme performs a number of functions: breaking down complex molecules into simple substances, assembling amino acids into peptide chains, playing a role in metabolism, and so on. The expanding biotechnology industry due to technological advancement is driving the growth of alkaline proteases market. The rise in the investment in research &development activities is again expected to augment market growth. High demand for proteases from the soaps & detergents industry is also projected to foster the market growth of alkaline proteases. Growing hygiene awareness and increasing demand for the food industry for the preparation of food products is also projected to propel the market growth. Furthermore, the growing demand for environmentally friendly products across emerging economies and increasing use of proteases as therapeutic agents is further projected to augment the growth of alkaline proteases market. Read more @ https://coherentmarketinsights-blog.blogspot.com/2021/01/advancement-in-biotechnology-sector-has.html

Pulmonary Arterial Hypertension (PAH) is a disease that affects the vasculature of the heart, specifically the arteries that transport blood from the heart to the lungs. Common symptoms include heart palpitations or an irregular rhythm, chest pain, coughing, wheezing, shortness of breath, chest discomfort when breathing, and sometimes even heart failure. The cause of pulmonary hypertension is not known, but research has indicated that genetic and hormonal factors may play a role in its development. The growing prevalence of Pulmonary Arterial Hypertension (PAH) is driving the growth of the Pulmonary Arterial Hypertension (PAH) Market. According to the European Respiratory Society, PAH is a rare disease, with an estimated prevalence ranging from 10 to 52 cases per million. The growing geriatric population is again increasing the prevalence of such disease which is also projected to foster the growth of the Pulmonary Arterial Hypertension (PAH) market. According to the United nation, by 2050, one in six people in the world will be over age 65 (16%), up from one in 11 in 2019 (9%). By 2050, one in four persons living in Europe and Northern America could be aged 65 or over. North America is projected to gain significant growth over the forecast period and this is attributed to the growing adoption of advanced treatment for treating pulmonary arterial hypertension. Moreover, increasing spending by the government on the healthcare sector is again augmenting the regional market growth. According to the U.S. Centers for Medicare & Medicaid Services, National health spending is projected to grow at an average annual rate of 5.4 percent for 2019-28 and to reach $6.2 trillion by 2028. Reads more @ https://coherentmarketinsights-blog.blogspot.com/2021/02/increasing-global-healthcare-spending.html

Tynor Wrist Brace with Thumb is created to reinforce, prevent and partially immobilize the wrist and the palm. This wrist brace allows natural and free activity of the fingers. It keeps the affected area compact and maintains the body heat to lessen the local pain inflammation. Its has high quality striped elastic webbing which provides high modulus of elasticity which gives the comfortable feel. It is made from the strong, durable, porous and a comfortable material which remains for a long time. This Wrist Brace provides excellent compressive strength and support to the wrist. Its Hook loop closures allow easy application and removal. It fits comfortably around the wrist and comes in universal sizing. It also has an anatomical thumb opening which fastens the healing process. It keeps the thumb in relaxed and comfortable position. Its extra porous material allows the proper ventilation to the affected skin. Tynor Wrist Brace with Thumb Wrist brace with thumb is designed to support, protect and partially immobilize the wrist and the palm while allowing free and natural movement of the fingers. It compresses the area and retains the body heat to allay local pain and inflammation. Extra grip. Extra porous Controlled compression. Anatomical thumb placement. Tynor Wrist Brace with Thumb Features High quality , striped elastic webbing Strong and durable Porous and comfortable High modulus of elasticity- Retains shape and size for a long time. Excellent compressive strength, better support Hook loop closures Easy to apply and remove Ensures optimal compression Better fitting and universal sizing. Anatomical thumb opening Better pain relief and healing. Thumb in abduction remains relaxed, no fatigue Improves comfort Allows free and natural movement of the thumb and fingers. Tynor Tennis Elbow Support Tennis Elbow Support is designed to help provide relief from generalized pain and tenderness in the forearm and elbow caused by repetitiv

Enteral feeding devices technological advanced medical device used to deliver nutrition food directly to the stomach to the bedridden patient suffering from chronic diseases such as cancer and neurological disorder. The increase in the cases of malnutrition and premature birth cases around the globe is a prime factor driving growth of the enteral feeding devices market. Moreover, the growing prevalence of chronic diseases such as cancer and cardiovascular disease is another key factor fostering the market growth of the enteral feeding devices. According to the World Health Organization, cancer is the second leading cause of death globally and is responsible for an estimated 9.6 million deaths in 2018. Globally, about 1 in 6 deaths occur due to cancer. Around 70% of deaths from cancer occur in low- and middle-income countries. Furthermore, increasing global expenditure on the healthcare sector for improving the patient care is further projected to augment the growth of the enteral feeding devices market. From the geographical perspective, North America is projected to gain significant growth over the forecast period and this is attributed to the high presence of the geriatric population prone to chronic disease that leads to digestive ailments. Read more @ https://coherentmarketinsights-blog.blogspot.com/2020/12/enteral-feeding-devices-to-gain.html

For so many years, medical science professionals have been focused on developing cost-effective and efficient methods of treatment and diagnosis. Genomics refers to the study of genetics, which covers how a single gene affects a particular disease to the entire genome. It is also an interdisciplinary field of research focusing on the genetic architecture, function, sequencing, mapping, and editing of human genomes. A human genome consists of all the genetic information that makes up a particular individual, which has resulted in many important advances in medicine and in helping scientists understand the genetic makeup of the human body and the environment in which the cells grow and multiply. One of the most significant advances in the field was the discovery of the Human Genome Diversity Project (GHD), which revealed that all people have varying degrees of genetic variation within their genomes. Moreover, the Human Genome Project also resulted in the first genome maps and maps that can help researchers determine where specific mutations have been inherited. Read More @ https://www.blogger.com/blog/post/edit/preview/9197580861156902959/8311782016390208480

Micro guide catheters are used in order to guide the urethra so that you can have an easy time inserting your pet's urethra and not be worried about any kind of blockage at all. There are many types of these devices available in the market. Some of these are manual tube and electric as well. Many people prefer to use micro guide catheters because they are made very simple and with great ease of use. A growing number of surgical procedures for treating cardiovascular diseases is fueling the growth of the micro guide catheters market. According to the American College of Cardiology Foundation, in 2017, emergency medical services-assessed out-of-hospital cardiac arrest occurred in an estimated 356,461 Americans; emergency medical services treatment was initiated in 52%. In the United States in 2019, coronary events are expected to occur in about 1,055,000 individuals, including 720,000 new and 335,000 recurrent coronary events. The increasing development of modern disposable catheters that are safer and more comfortable to insert is further projected to foster the growth of the micro guide catheters market. North America is projected to gain significant growth over the forecast period and this is attributed to the continuous launch of innovative products by ley players in the region. For instance, in March 2017, Teleflex Inc. has announced 510(k) clearance by the U.S. Food and Drug Administration (FDA) and the U.S. commercial launch of the TrapLiner Catheter. The TrapLiner Catheter was developed by Vascular Solutions Inc., which was acquired by Teleflex. Read more @ https://coherentmarketinsights-blog.blogspot.com/2021/02/rise-in-number-of-cardiovascular.html

Tynor Wrist Brace with Thumb Wrist brace with thumb is designed to support, protect and partially immobilize the wrist and the palm while allowing free and natural movement of the fingers. It compresses the area and retains the body heat to allay local pain and inflammation. Extra grip. Extra porous Controlled compression. Anatomical thumb placement. Tynor Wrist Brace with Thumb Features High quality , striped elastic webbing Strong and durable Porous and comfortable High modulus of elasticity- Retains shape and size for a long time. Excellent compressive strength, better support Hook loop closures Easy to apply and remove Ensures optimal compression Better fitting and universal sizing. Anatomical thumb opening Better pain relief and healing. Thumb in abduction remains relaxed, no fatigue Improves comfort Allows free and natural movement of the thumb and fingers.

"Dental Caries - Pipeline Review, H1 2013"provides an overview of the indication's therapeutic pipeline. This report provides information on the therapeutic development for Dental Caries, complete with latest updates, and special features on late-stage and discontinued projects.

"Dental Pain - Pipeline Review, H1 2013" information on the therapeutic development for Dental Pain, complete with latest updates, and special features on late-stage and discontinued projects.

Overview: Drug and device research is confusing and difficult on its own but when you start combining drugs with devices the regulatory landscape changes as there are more nuances to deal with. Knowing how drug and device studies are each regulated is important in navigating the challenges posed by studies that wish to use both. It is also important to be aware of current guidance affecting the use of both drugs and devices in a study as well current guidance affecting the classification of devices. Why should you attend: Information on drugs and devices is plentiful. But, it can also be daunting .The webinar will give attendees a foundation and a starting point on which they can build. Learning objectives: Define drug research Define device research Explore the differences between the two Describe requirements when drugs and devices are combined in one study Areas Covered in the Session: Defining Drug Research FDA approved drugs Investigational drugs Compassionate use Defining Device Research FDA approved devices 510 K devices Humanitarian Device Exemptions Invitro Diagnostic Devices Investigational Devices Federal regulations governing drugs and devices Guidance governing drugs and devices Combining devices and drugs into one study What are the requirements? What are the regulations and guidance? How these studies are reviewed Who Will Benefit: Investigators Researchers Research Staff Study Coordinators Auditors Research Administrators Speaker Profile Sarah Fowler-Dixon is Education Specialist and instructor with Washington University School of Medicine. She has developed a comprehensive education program for human subject research which has served as a model for other institutions. She crafted budgets, policies, procedures, reporting, and training for the new program. She has initiated the planning, development, authorship and implementation of many human subjects research policies, practices, guidelines, submission and reviewer forms often working with st