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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

There are a lot of neurovascular therapies which can help in the reduction of your stress levels, improve your overall health and boost your overall health and well-being. This includes spinal decompression, neurovascular vascular technologies and nerve stimulators, vascular therapies and neurovascular imaging. Recent reports from the U.S. National Center for Complementary and Alternative Medicine indicates that neurovascular therapy is being used more frequently than ever before in the past. The number of people opting for this treatment is increasing by two to three times annually. Currently, there is no better way to boost your brain's health and prevent neurological diseases than through neurovascular therapies. Rising need for minimally invasive surgical procedures, higher number of research studies in neurovascular technologies and rising expectation for minimally invasive surgery techniques will provide ample opportunities to the industry growth. In fact, studies suggest that the average cost of neurosurgery has decreased by around 40 percent, which has made it more affordable for more patients to undergo such treatment. Also, the increasing demand for medical devices has resulted in the rise of numerous new medical equipment manufacturers that have been able to offer lower costs as compared to other equipment providers. In the past, non-surgical methods of treatment were primarily limited to treatments using pacemakers or other devices. As the technology became available, the field of neurosurgery expanded and a large number of non-surgical options such as spinal surgery were introduced. Nowadays, spinal surgery is only one of the available neurovascular treatments but is fast catching up. With so many benefits, it is no wonder that the neurosurgeon industry has increased its revenue by more than five times since 1980. Read More @ https://www.blogger.com/blog/post/edit/preview/9197580861156902959/2930096643408701069

Course "The A to Z's of HIPAA Privacy, Security, and Breach Notification Rules" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion. Overview: This session is designed to provide intensive, two-day training in HIPAA compliance, including what's new in the regulations, what's changed recently, and what needs to be addressed for compliance by covered entities and business associates. The session provides the background and details for any manager of healthcare information privacy and security to know what are the most important privacy and security issues, 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. Who Will Benefit: * Information Security Officers * Risk Managers * Compliance Officers * Privacy Officers * Health Information Managers * Information Technology Managers * Medical Office Managers * Chief Financial Officers * Systems Managers * Legal Counsel * Operations Directors Agenda: Day One Day one sets the stage with an overview of the HIPAA regulations and then continues with presentation of the specifics of the Privacy Rule, recent changes to the rules, and the basics of the Security Rule Lecture 1: Overview of HIPAA Regulations * The Origins and Purposes of HIPAA * Privacy Rule History and Objectives * Security Rule History and Objectives * Breach Notification Requirements, Benefits, and Results Lecture 2: HIPAA Privacy Rule Principles, Policies and Procedures * Patient Rights under HIPAA * Limitations on Uses and Disclosures * Required Policies and Procedures * Training and Documentation Requirements Lecture 3: Recent and Proposed Changes to the HIPAA Rules * New Penalty Structure * New HIPAA Audit Program * New Patient Rights

Hospital Management : The growth and development of hospitals has led to an altogether specialized discipline -hospital management. Hospital management is about coordinating the various functions of a hospital and ensuring optimal healthcare to patients and other stakeholders. Hospital Management has come a long way from being a supplementary duty that senior doctors handled with ease, to being a full-fledged specialization in itself. Hospital management is an altogether fully developed specialist profession whose managers are well qualified. Many institutions today offer courses on hospital management. The relationship of hospital management to the area of management rather than to the medical field can be understood from the fact that many hospital managers are from a purely management background, and have little knowledge of medical science. Many hospital management institutions offer an MBA. They also offer courses on specialized subunits of hospital management, such as hospital financial management, healthcare system management, hospital human resources management, etc. This is because hospitals have evolved over time. They are now ultra-specialist healthcare providers that use the latest technologies. A hospital could use anything from billing software to highly sophisticated technology used in its medical devices. A hospital management specialist needs to be not only aware of these uses; she also needs to be/have all these: A good administrator who handles staff; A deep knowledge of the information systems; A good grip on all the systems that need to be coordinated thoroughly if the hospital needs to function smoothly without any hassles; Dealing with facilities for patients. Hospital Management can thus be understood as being the facilitator between a healthcare setting and those who need these services. It is about ensuring that all the administrative elements of a healthcare setting function in unison to ensure provision of accountable healthcare.

The blood gas analyzer is a device used to determine the number of electrolytes in the human plasma of animals. Electrolytes are substances that are positively charged and have a negative charge. Blood cells are the positive charge electrolytes and oxygen is the negative charge electrolytes. Blood contains a variety of these different electrolytes and when a medical condition occurs, it may result in an imbalance of the electrolytes in the blood. The difference in the levels of these electrolytes results in the various symptoms and conditions that can occur. The increasing popularity of the medical field has led to an increased prevalence of the so-called medical laboratory tests' in recent times. These laboratory tests have been designed and developed in such a way as to measure the levels of various constituents of the blood, which is critical for the proper functioning of the human body. The blood gas analyzer is a perfect example of one of these instruments. The blood gas analyzers is highly useful in critically ill patients who require monitoring of their vital signs at all times. Intensive care patients often require a high concentration of oxygen saturation and other oxygen isotopes. In such cases, a reliable blood gas analyzer is very important. Read more @ https://coherentmarketinsights-cmi.blogspot.com/2021/01/is-blood-gas-analyzer-beneficial-in.html

The process of sterilization and disinfection has always been crucial in maintaining optimum hygiene in any given setting. However, the ongoing COVID-19 pandemic has heightened the importance of these processes. Sterilization refers to any process that removes, eradicates, or kills all forms of life particularly, fungi, bacteria, viruses, spores, etc. Sterilization equipment and disinfectants are crucial in modern medical care as patients come in contact with syringes, surgical tools, and bandages all time. These medical devices eliminate any foreign particles, pus, blood, and dirt left behind that could create complications for the next patient requiring surgery. Besides, it decreases bioburden and prevents corrosion of expensive and highly precise tools. There are different sterilization processes performed including steam sterilizing, flash sterilizing, low-temperature sterilizing, hydrogen peroxide gas plasma, ethylene oxide gas sterilization, peracetic acid sterilization, etc. Many regulatory authorities have issued guidelines on how to sterilize medical equipment. The hospitals refer to it as a germ warfare strategy and it is done in a specific order. The first step is cleaning followed by disinfection which involves using liquid chemicals to kill non-spore-forming bacteria. The final step is sterilizing where several methods are employed to kill disease-causing microorganisms and also eradicate transmissible agents such as spores and bacteria. Read more @ https://coherentmarketinsights-cmi.blogspot.com/2020/12/sterilization-equipment-and.html

Epilepsy also referred to as a seizure disorder in which nerve cell activity in the brain is disturbed causing seizures. Over 50 million cases of epilepsy are observed across the globe with 80% of them living in emerging economies. Generally, epilepsy is treated by medication, while some cases require surgery, devices, or dietary changes. Over the years, various antiepileptic drugs have been approved and introduced in the market. Each new antiepileptic medication is well tolerated and shows statistically significant improvements in seizure frequency over time compared to pretreatment. However, these medications each carry their own set of challenges and limitations that must be addressed to patients taking them. Carbamazepine, a member of the benzodiazepine class, is antiepileptic drugs used to treat patients with symptomatic epilepsy and other forms of non-epilepsy epilepsy. It is typically administered intravenously or intramuscularly. Patients must be carefully monitored for allergic reactions and heart and blood pressure effects. Read more @ https://coherentmarketinsights-cmi.blogspot.com/2020/12/antiepileptic-drugs-are-getting-better.html

"Endoscopy Devices: Applications and Global Markets"This report provides a comprehensive analysis of the global market for endoscopy services and equipment.

The increasing adoption of positive airway pressure (PAP) devices, such as continuous positive airway pressure (CPAP) devices, is one of the major factors driving the growth of the sleep apnea devices market in Saudi Arabia. PAP therapy is considered the gold standard treatment for obstructive sleep apnea (OSA), which is the most common type of sleep apnea. PAP devices deliver pressurized air through a mask to keep the airway open during sleep, preventing breathing pauses and snoring.

Gastroesophageal Reflux Disease (GERD) is a chronic condition that is characterized by the regurgitation of stomach contents into the throat. GERD is also known as acid reflux disease and it occurs in people of all ages. In milder cases, GERD can be effectively treated with simple pharmacological therapies or by altering a patient's diet. In more severe cases, esophageal surgery might be necessary to remove the troublesome esophageal sphincter and/or improve a patient's general physical condition. GERD can develop when the lower esophageal valve relaxes or becomes weakened. The diagnosis of GERD and gastroesophageal reflux disease can be done by examining the medical history and symptoms. Although acid-reflux disease typically affects the upper body, some of its symptoms can extend down the esophageal tract, making GERD particularly troubling for people who sit or stand for long periods of time. This problem has given rise to a variety of different approaches to treatment, including invasive, surgical treatments, non-surgical treatments and more novel, non-invasive therapeutic approaches. The latest treatment option on the table involves using pharmaceuticals, such as selective serotonin reuptake inhibitors (SSRIs), to help reduce the effects of GERD. There are a number of advantages to this strategy. For starters, SSRIs are believed to have numerous side effects that tend to make them less attractive to certain groups of patients. Electrical stimulation (ESD) is another common form Gastroesophageal Reflux Disease (GERD) Treatment Devices. This technique involves the use of electrodes attached to the esophageal wall to generate a varying amount of electrical current. Antirheumatic drugs, which often cause symptoms similar to those of severe heart disease, are sometimes added to the mixture. A major disadvantage of using plicator devices with ESD is that the procedure can only be performed on an outpatient basis, requiring a patient to remain in the hospital for a fe

The factors such as rise inpreference for minimally invasive surgeries and increase inprevalence of peripheral & coronary heart diseases are expectedto boost the growth of the atherectomy device market in thecoming years. Furthermore, favorable medical reimbursement scenario from the government is anticipated to propel theatherectomy devicemarket growth. However, lack of skilled professionals and stringent regulatory scenario is expected to restrain the market growth.

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

Rationale for Clinical Trial Regulations Clinical trials, as we all know, are carried out to test the efficacy of a new drug or device being developed for a specific condition or disease. Clinical trials are experiments that have a high degree of risk if they are not properly implemented. For this reason, it is necessary for regulatory bodies to regulate clinical trials. The core rationale for regulating the various stages of clinical trials is that human subjects, who are part of the research, have to be protected. These clinical trial regulations are legislated at all stages: local, State, national and international. Clinical trial regulations are in force in different countries of the world. Common clinical trial regulations are also made globally by the International Conference on Harmonization (ICH), which has the mandate of setting out good practices for clinical trial regulations for trials done in global cooperation. These regulations cover the administrative, procedural and ethical aspects of clinical trials. Briefly, these are the areas in which there are clinical trial regulations for each of these aspects of clinical trials: Administrative: The administrative aspects of clinical trial regulations pertain to the way the clinical trials are run, and the way they are tracked and monitored throughout their lifecycle. A clinical trial is usually monitored by a sponsoring company or a Contract Research Organization (CRO), which the former hires at times for reasons of convenience and cost cutting. Clinical trial regulations in this area is obviously of importance because if something goes wrong at any administrative stage; these can be rectified. Procedural: Procedural aspects of clinical trial regulations relate to ways by which subjects are chosen for a clinical trial. Proper care has to be taken to ensure that the subjects are appropriate for the clinical study, are from the prescribed age, geographical, demographic, racial and gender-related cl

Disposable syringes are designed for one-time use and is discarded in order to prevent the spreading of infection. It can be defined as a sterile cylindrical medical instrument with a hollow needle at the end. This device act as a pump that easily draws drugs from vials and delivers these drugs to the body. A syringe is used to deliver injectable drugs in the body through an intravenous route. The growing use of injectable drugs across the healthcare sector is predominantly fueling the market growth of disposable syringes. The rise in global healthcare expenditure is another key factor propelling the market growth of disposable syringes. According to the World Health Organization, global spending on health was US$ 7.8 trillion in 2017 or about 10% of GDP and $1,080 per capita - up from US$ 7.6 trillion in 2016. Moreover, the growing demand for self-injection devices & long-acting formulations is again propelling the market growth. Increasing spending on R&D of new drugs development coupled with the growing demand for biologics will further favor the market growth of disposable syringes. Furthermore, growing concerns regarding needle stick injuries and accidental infections are also expected to bolster the market growth of disposable syringes. Read more @ https://coherentmarketinsights-blog.blogspot.com/2020/11/increasing-spending-on-r-of-new.html

Chronic renal failure, or renal overload, is associated with a variety of morbidity and mortality and is a major challenge in the clinical treatment of patients with chronic renal failure. This disease has no cure and can be managed with specific medications in an appropriate course of therapy. However, in patients for whom other therapies have been ineffective or who are experiencing life-threatening side effects, continuous renal substitute therapy (CRS) is the only feasible treatment. Continuous Renal Replacement Therapy (CRRT) is a type of blood purification therapy used in the treatment of patients with acute kidney injury. The therapy is commonly used to provide renal support for critically ill patients with acute kidney injury, particularly patients who are hemodynamically unstable. Emergence of COVID-19 has led to increasing adoption of CRRT as patients with Covid-19 are experiencing multiple organ failure, including acute kidney injury. Moreover, regulatory bodies are also focused on approval and launch of new CRRT devices. For instance, in April 2020, The U.S. Food and Drug Administration granted marketing authorization for a new device indicated to provide continuous hemodialysis or hemofiltration therapy to critically ill pediatric patients weighing between 2.5 and 10 kilograms (or 5.5 to 22 pounds). Read more @ https://coherentmarketinsights-cmi.blogspot.com/2020/12/demand-for-continuous-renal-replacement.html

Nucleic Acid Testing reort presents strategic assessments of current and emerging suppliers of nucleic acid testing products, including their sales, product portfolios, marketing tactics, technological know-how, new products in R&D, collaborative arrangements and business strategies.