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Respiratory syncytial (sin-SISH-uhl) virus, or RSV, is a common respiratory virus that usually causes mild, cold-like symptoms. In the U.S., RSV infections generally occur during fall, winter, and spring. Treatment for respiratory syncytial virus usually involves self-care steps to help make your child relaxed (supportive care) along with medication, if needed (acute care). But if severe symptoms appear, hospital treatment may also be necessary. Symptoms of the virus include, runny nose and cough, difficulty breathing, wheezing, fever, sore throat, headache, swelling of face and lips, and red spots on the mouth and tongue. Left untreated, your child's condition may develop into complicated pneumonia, acute congestive heart failure or sudden infant death. Respiratory syncytial virus diagnostics may include, a simple test that can detect early symptoms, so you can provide the appropriate treatment as soon as possible. If you have any symptoms of upper respiratory infection or strep throat, you should see your doctor. The doctor will test your upper respiratory infection or strep throat for viruses such as parainfluenza, rhizopenia and streptococcus. In some cases, your doctor will also order laboratory tests in order to get an accurate diagnosis. Read more @ https://coherentmarketinsights-cmi.blogspot.com/2020/12/a-simple-test-that-detects-early.html

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 "HIPAA Security & Privacy Official - Roles and Responsibilities" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion. Overview: Being the HIPAA Security and Privacy Official involves not only ensuring you know the appropriate patient rights and controls on your uses and disclosures of protected health information, but you also have the proper policies and procedures in place. If audited or the subject of a compliance review you will be required to show the government you have all the necessary documentation in place for safeguarding patient Protected Health Information and indicate how you addressed all required security safeguards. This starts with the fundamentals of a HIPAA compliance program. If your HIPAA Security and Privacy Official needs to understand what all the HIPAA requirements are or make sure the current program is adequate and can withstand government scrutiny, please join us for this informative and interactive seminar. Why you should attend: The HIPAA Security and Privacy Official is the backbone of any organization's compliance program. Often times this role is assigned as collateral duty in smaller organizations. Regardless the size of an organization, the HIPAA Security and Privacy Official must know all the requirements for compliance. This is a critical element of the position. Attendees will leave the course clearly understanding the role and all the requirements as the designated as a HIPAA Security and Privacy Official. This seminar will cover reviews, creation, and amending policy and procedure. After completing this course, a HIPAA Security and Privacy Official will have a clear understanding for what needs to be place when it comes to all of the HIPAA regulations. Areas Covered in the Session: Why was HIPAA created? The Role and Responsibilities of the HIPAA Security and Privacy Official Complying with HIPAA Requirements? What are the HIPAA Security

Course "HIPAA for the Compliance Officer" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion. Overview: I will be going into great detail regarding you practice or business and how it relates to the HIPAA Security/Privacy Rule, Areas covered will be history of HIPAA, privacy vs security, business associates, changes for 2016, audit process, paper based PHI, HIPAA and suing, texting, email, encryption, medical messaging, voice data and much, much, more I will uncover myths versus reality as it relates to this very enigmatic law based on over 600 risk assessments performed as well as years of experience in dealing directly with the Office of Civil Rights HIPAA auditors. I will also speak to real life audits conducted by the Federal government (I've been on both sides of these audits) what your highest risks are for being fined (some of the risk factors may surprise you). In addition, this course will cover the highest risk factors for being sued for wrongful disclosures of PHI and the manner in which patients are now using state laws to sue for wrongful disclosures. Don't always believe what you read online about HIPAA, especially as it relates to encryption and IT, there are a lot of groups selling more than is necessarily required. Why you should attend: This lesson will be addressing how practice/business managers (or compliance offers) need to get their HIPAA house in order before the imminent audits occur. It will also address major changes under the Omnibus Rule and any other applicable updates for 2016. There are an enormous amount of issues and risks for covered entities and business associates these days. I will speak on specific experiences from over 17 years of experience in working as an outsourced compliance auditor, expert witness on HIPAA cases, and thoroughly explain how patients are now able to get cash remedies for wrongful disclosures of private health information. More im

Course "HIPAA - Putting an Organizational Compliance Program in Place" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion Overview: Being in compliance with HIPAA involves not only ensuring you provide the appropriate patient rights and controls on your uses and disclosures of protected health information, but you also have the proper policies and procedures in place. If audited or the subject of a compliance review you will be required to show the government you have all the necessary documentation in place for safeguarding patient Protected Health Information and indicate how you addressed all required security safeguards. This starts with the fundamentals of a HIPAA compliance program. If your healthcare practice, business, or organization needs to understand how to put HIPAA compliance program in place or make sure the current program is adequate and can withstand government scrutiny, please join us for this informative and interactive 2 day training course. Why you should attend With an increase in HIPAA enforcement and Phase 2 audits underway, many organizations need to fully understand the requirements of a compliance program. Attendees will leave the course clearly understanding of all the requirements for a comprehensive HIPAA compliance program and what steps need to be taken to mitigate risk. The seminar will include practical exercise to assist in knowing how to develop, review, and amend HIPAA policy and procedure. After completing this course, a Covered Entity or Business Associate will have a clear roadmap for what needs to be place when it comes to all of the HIPAA regulations. Areas Covered in the Session * Why was HIPAA created? * What is HITECH and the Omnibus Rule? * Who Must Comply with HIPAA Requirements? * What are the HIPAA Security and Privacy Rules? * What is a HIPAA Compliance Program? * What is a HIPAA Risk Management Plan? * What is meant by

Course "Texting and E-mail with Patients: Patient Requests and Complying with HIPAA " has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion. Overview: With the recent advances in portable technology, more and more organizations and their users are taking advantage of mobile devices to save time and get work done more efficiently. Texting, portable e-mail, and Apps are revolutionizing the ways health care providers interact with their patients and get their work done. But the use of these devices comes with hidden costs of compliance, especially if they lead to a reportable breach under HIPAA or state laws. HIPAA Privacy and Security Officers have been struggling to keep up with the use of the devices to protect patient privacy and avoid compliance issues. Even if these devices aren't in formal use in your organization, you need to act now to anticipate their use and make sure they are used properly. This session is designed to provide intensive, two-day training in HIPAA compliance as it relates to the use of mobile devices, including how to use them with Protected Health Information, the policies and procedures you need to have in place to use them securely, and how to manage issues of the "BYOD" phenomenon. The session provides the background and details for any manager of health information privacy and security to know what issues to look for with mobile devices, what needs to be done for HIPAA compliance, and what can happen when compliance is not adequate. Audits and enforcement will be explained, as well as privacy and security breaches and how to prevent them. Numerous references and sample documents will be provided. The session will be valuable for both newcomers to HIPAA compliance as well as seasoned veterans. HIPAA compliance will be explained and discussed in detail, from the basics through the latest changes and new technology issues, so that the attendee will have a coherent u

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

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Diagnosing Cancer at its earliest stages usually provides the most effective probability for a cure. The days - or even weeks - spent waiting for the results of a cancer-screening test can feel like perpetuity. Especially when the early diagnosis and treatment are tied to better outcomes. Now, a new technique to analyze proteins implemented on cancer cells shows promise in rapidly detecting these cell types.

Large HMOs and hospital organizations have experienced the benefits associated with electronic medical record system software almost from its first creation. These companies were the earliest of early adopters, with EMR a part of their company structure as considerably back in the 80s and early 90s. Managing these assets and patient records has recently been a boon to bigger organizations, with most EMR systems paying for themselves many times over.

Primary biliary cholangitis, also known as primary biliary cirrhosis, is an autoimmune disease of the liver. The auto-immune disorder can have a number of symptoms such as abdominal pain, fever, nausea, vomiting, abdominal bloating, diarrhea, liver tenderness or enlargement, jaundice, and ascites. In most of these symptoms, the patient may be experiencing inflammation at an early stage of the illness, although in some cases, symptoms do not appear until the disease has advanced to a more serious state. A definitive diagnosis can only be made by performing blood tests and ultrasound studies in order to determine the progression of the illness and its effects on the body. At an early stage, most patients who experience mild to moderate symptoms of primary biliary cholangitis exhibit no symptoms, whereas in some cases, symptoms manifest very quickly and rapidly worsen. In both conditions, the majority of affected individuals undergo treatment that is aimed at relieving pain and treating any complications that might occur. High prevalence of primary biliary cholangitis is expected to propel growth of the primary biliary cirrhosis drugs market. For instance, according to the study, 'Epidemiology and clinical course of primary biliary cholangitis in the Asia-Pacific region: a systematic review and meta-analysis', published in Hepatology International in September 2019, the overall prevalence of primary biliary cholangitis was 118.75 cases per million in the Asia Pacific region, with the high, medium and low prevalence being in Japan and China (191.18 cases per million), New Zealand (99.16 cases per million) and South Korea and Australia (39.09 cases per million), respectively. Read more @ https://coherentmarketinsights-blog.blogspot.com/2021/01/high-prevalence-of-primary-biliary.html

Bone cancer treatments are used all over the world, especially in regions such as the US, UK, and Italy. The standard bone cancer treatment of all types and stages of bone cancer consists of surgery. Surgeons will surgically remove the entire cancerous growth from the bone and surrounding healthy tissue, including lymph nodes. Sometimes, surgeons will only target the lymph nodes. In the bone, surgeons employ limb-sparing methods when possible. Radiation therapy as bone cancer treatment is often used for bone cancer treatment. This kind of treatment is very successful at removing all cancerous cells from the affected area. It uses high-energy radiation beams that are targeted at cancerous growth. Although radiation bone cancer treatment can remove some of the symptoms, it is not a guarantee of complete removal of the disease. This method may give an early diagnosis, but it does not guarantee a successful treatment. However, if this bone cancer treatment is conducted early enough, it will help to slow the spread of the disease. Read more @ https://coherentmarketinsights-cmi.blogspot.com/2021/08/bone-cancer-treatments-are-administered.html

Opening up the possibility for early diagnosis of ovarian cancer, scientists have identified genetic material that distinguishes its cells from normal cells.

Breast cancer is the type of cancer that has a valid preventive strategy if we're talking about active prevention. There are about 1.38 million new cases and 458 000 deaths from breast cancer each year. Early diagnosis is a cornerstone for breast cancer care.

Cardiac markers are special antibodies measured in the blood to measure heart function. They can also be used in the detection or early diagnosis of certain diseases. Although they're usually associated with myocardial infarction, they can also be indicative of many other conditions. For instance, hyperthyroidism and thyroid prophylaxis can result in an elevated elevation in plasma marker levels. As per the American Heart Association (AMA), in 2016, cardiovascular disease accounted for 17.6 million deaths across the globe. The ECG is one of the most useful cardiac marker testing device. It measures the cardiac output and provides detailed information about heart conditions. This test is used to diagnose heart diseases and the complications that can arise from the disease. ECG is one of the most widely used tests. ECG is conducted while the patient is lying down on the table. A technician places electrodes either in or on the skin surface. The test is normally performed for different purposes. Read more @ https://coherentmarketinsights-cmi.blogspot.com/2021/03/cardiac-marker-testing-devices-have.html

Immuno-Transcriptomics firm Novigenix has received positive results from its early colon cancer detection blood test at the European Society for Medical Oncology (ESMO) 2019.

Course "Tougher Import Rules for FDA Imports in 2016" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion. Overview: FDA's and the Customs and Border Patrol Service (CBP) have become increasingly sophisticated and equally demanding in the submission of information and adherence to government procedures. Firm's that fail to understand and properly execute an import and export program find that their shipment is delayed, detained or refused. In 2016 entries must use the Automated Commercial Environment (ACE) entry filing system or face entry refusals and monetary penalties up to $10,000 per offense. A number of other factors can derail the expectation of a seamless import process. The course covers detailed information about the roles and responsibilities of the various parties with an import operation and how to correct the weakest link(s) in the commercial chain. The course will include tips on how to understand FDA's thinking and offer anecdotal examples of FDA's import program curiosities. Why should you attend: What happens when your product is detained? FDA will begin a legal process that can become an expensive business debacle. You must respond fully within short timeframes. This is not the time for you to be on a learning curve. You need to have a plan in place and know what you are doing. The FDA is steadily increasing the legal and prior notice information requirements. If you do not know what those requirements are and you initiate a shipment, your product is figuratively dead in the water. You must be accurate with the import coding information and understand the automated and human review process. If not, you can expect detained shipments. CBP is implemented a new "Automated Commercial Environment" computer program that changes import logistics and information reporting for FDA regulated products. Your shipment may be stopped before it is even loaded at the foreign port. What

What is Corporate Governance? In a broad sense, corporate governance can be defined as a set of processes by which corporations are run and administered. These are a collective function of the critical, core decision makers in the organization, such as Directors, CEO, managers, investors, stakeholders, shareholders, creditors, auditors and others. Corporate Governance sets out the methods and rules for making rules that govern corporate entities. Although business is the main concern and task of an organization, Corporate Governance occupies as important a position, because while the financial aspect of a business is all about profits, the Corporate Governance aspect is primarily about its integrity, values and reputation. Corporate Governance takes into consideration all aspects of the governance of the organization from critical standpoints such as ethics, regulatory aspects, policies and mission, etc. History of the growth of Corporate Governance Although Corporate Governance has been around for a number of decades in some or another form, it came to acquire proper shape and direction of late, following the collapse of very big multinationals such as Enron, WorldCom and others. It was felt that their shady dealings, which led to huge losses for their stakeholders and eventually to the businesses collapse, could have been averted if a proper regulatory framework of Corporate Governance were in place. This is the feeling that led to the passing of the Sarbanes Oxley Act, or SOX in the early 2000's. One of the core principles enunciated in SOX related to Corporate Governance. Elements of Corporate Governance As a result of the SOX Act and other legislations in other developed countries, such as the Cadbury Report of the UK and other legislations in the OECD nations; Corporate Governance is now administered through a well-defined set of principles. As a result of these legislations, Corporate Governance is now concerned with the following: Problems areas of Co