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Standard Operating Procedures for Clinical Trials: A set of standard operating procedures for clinical trials is absolutely vital for ensuring the effectiveness of the study for a number of reasons. Standard operating procedures for clinical trials are a very potent means to help researchers, principals or sponsors ensure the accuracy and consistency of the procedures needed for the clinical trial. What are standard operating procedures for clinical trials? Standard operating procedures for clinical trials are written instructions that are detailed to provide information about every aspect of the trial. With this set of standard operating procedures for clinical trials, principals seek to bring about a level of uniformity in a particular task of the clinical trial. Consistency in these standard operating procedures for clinical trials has to be ensured so that the clinical trial meets local, state and federal government and global guidelines and requirements. Equally importantly, standard operating procedures for clinical trials have to also meet regulatory guidelines set out by bodies such as the FDA. The purpose of standard operating procedures for clinical trials should be to help the trial achieve consistency in the quality control and quality assurance. In addition, standard operating procedures for clinical trials should be designed to help the trial achieve the quality of auditability. This is because any clinical trial goes through audits from regulatory bodies, making the role of standard operating procedures for clinical trials all the more important. Factors to bear in mind while establishing standard operating procedures for clinical trials: Standard operating procedures for clinical trials should thoroughly document these among other elements: Event Reporting Safety Monitoring Laboratory Management Pharmacy Management Development of Protocols Informed Consent Operations at the site of the clinical trial While these may be considered the core asp

An operating room encompasses equipment such as operating tables, operating room lights, surgical booms, and operating room integration systems and surgical imaging displays. Operating room equipment include, operating table, OR lights, anesthesia machine, anesthesia cart, a stainless steel table for sterile instrument, electronic monitor, pulse oximeter machine, automated blood pressure measuring machine, electrocautery machine, a heart-lung machine, and others. Operating tables are very important for the operations of the surgery, as well as for the patient. They are often used for blood tests or other procedures that may require a quick and easy blood draw and can be very useful in this regard. Read More @ https://coherentmarketinsights-cmi.blogspot.com/2020/11/emergence-of-covid-19-has-led-to.html

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

Course "Fundamentals of Statistical Process Control: Implementation and Assurance of SPC" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion. Overview: This 2-day seminar provides the information you need to use one of the most powerful tools in quality, statistical process control. It will help people in design, quality, and production understand the concepts and effectively implement them. The examples and issues in the seminar come primarily from the medical device industry, but the material is applicable to any production environment. Production process must be controlled to help ensure they are stable. While there are many control methods, the most powerful and often used is statistical process control, SPC. It uses data from the process itself to detect changes - changes that could result from an unstable process. SPC helps determine if a process continues to operate the way it was set up. If not, SPC produces a signal that calls attention to the problem. One very important application is process capability analysis. With a stable process, SPC data can help determine if the process is capable of meeting the product specifications. These are often expressed as process capability indices. Continuous improvement programs can use the information generated by SPC to monitor process variation and identify its causes. These methods can reduce cost, improve product, and enhance customer satisfaction. Why should you attend: Manufacturing companies, especially medical device manufacturers, must control process. Not only is this a regulatory requirement, but is a good business practice. Without a solid understanding of SPC, you put yourself and your company at a disadvantage. On a personal basis, the material in this seminar will help improve your skills; it aligns with the ASQ Body of Knowledge for the Certified Quality Engineer, Green Belt, and Black Belt. These are areas you should master

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

Breast pump is a medical device used to elicit breast milk from lactating women. Breast pump products are available in two models, including manual breast pumps and electrical breast pumps. Breastfeeding is a special time in a woman's life, and moms should do whatever they can to ensure their babies get every ounce of their mom's love and attention. Let's take a look at a few important factors that will help you decide on the right pump for you. Battery-operated, smart electric, bag ups, single electric, hospital grade, dual electric, manual, and gravity fed are some of the various types of breast pumps. Smart breast pumps are great for new moms who want the convenience of pumping in the privacy of their own home. These are often battery-powered and can be manual or electric. The manual ones are easier to clean, but some women do not find a need for this feature. The electric models express milk more quickly and efficiently than the manual ones, but many women feel they don't remove much of the milk because of the suction power. Read more @ https://coherentmarketinsights-cmi.blogspot.com/2020/12/battery-operated-smart-electric-and.html

Course "Marketing Products without Getting Hammered by FDA" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion. Overview: With this seminar you will learn how to navigate FDA's legal requirements and its interpretations for enforcement purposes. The agency now applies the principles of cognitive psychology to aid in its determination of what a message really conveys. This becomes a new factor in trying to stay within FDA's legal corral. This conference will provide insight on how to manage your marketing activity and gauge what regulatory risks your business is willing to accept. You will learn how corporate management requires cooperation between marketing, regulatory affairs, legal counsel, manufacturing, engineering and finance departments. You will understand that a weak link in any department leaves the entire corporation vulnerable to FDA enforcement. Most importantly, you will understand the boundaries that FDA uses and how easy it is to cross them. With information from this course, you can step back and rationally evaluate your firm's regulatory profile for advertising and promotion. Why should you attend: If you go "off label" with advertising and promotion, you become embroiled in FDA's advertising and promotion requirements. For devices, the law is weak and lacks legal clarity. For drugs, FDA's law and regulations are extensive and have violated Constitutional protections. Depending on your point of FDA's promotion and advertising requirements can help you or hurt you? There is an inherent conflict in interests. In any case, you need to identify practical criteria to make marketing decisions. That begs the question of whether or not marketing managers and regulatory affairs managers will even try to agree on an issue. FDA's Center for Devices and Radiological Health (CDRH) has never issued a comprehensive guidance on advertising and promotion. You are on your own. CDER has esta

Practical steps to compliance with HIPAA Computer Policy: That the HIPAA has a clear and stringent policy on computers is absolutely understandable, because computers constitute the very soul of HIPAA. Ensuring security of patient data is one of the core causes for which HIPAA was enacted; so, it is only natural that Computer Policy should be at the center of HIPAA compliance. A HIPAA Computer Policy rule came into effect in 2005. The nub of this enactment is to ensure that there are technical, physical and administrative security procedures that must be adhered with. These are meant for Covered Entities to ensure that the data they have of patients, namely electronic Protected Health Information (PHI) is safe and secure. Understand the reason for HIPAA Computer Policy Any implementation has to start with an understanding of the rationale for the action, right? The same goes for something as important and big as implementation of HIPAA compliance into systems. HIPAA Computer Policy is in place for a specific and critical reason ���protection of patient data, loss of which can lead to hefty penalties that can affect the business very adversely. So, installing the necessary protections is the first step to protecting vital data and with it, one's own business or practice, as well. Implement a sound access policy A strong access policy is at the heart of HIPAA Computer Policy. It is in the computer systems that all the data relating to the patient are stored. So, making sure who in the organization has access to these and how and when, is very important. Not only should access be restricted to only designated and permitted personnel in the organization; there should be a system by which tracking of access is easily determined. This is to find out who accessed which record, when, what action followed, what happened as a result of this access, and so on. Keep a record of all system components This is another step to ensuring compliance with HIPAA Computer Po

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

Ankle Splint Ankle Splint is designed to immobilize, support and stabilize the ankle joint in injury, or offer protection to people prone to ankle injuries. Rigid exoskeleton shell design gives better protection and control of the inversion or aversion of the ankle. Rigid immobilization Foam cushioning One size, that fits all Anatomical Easy to clean. Ankle Splint Features Unique figure of eight gripping Effective control on inversion & eversion movement of ankle Most effective gripping around ankle. Enhances comfort and walking pleasure Large enough room for ankle Unconventional, swollen or distorted ankles can be accommodated No compression hot spots on the ankle , so enhances comfort to injured ankle Reduces chances of sports related injuries in recurrent ankle problems Quick healing and better recovery of the fully immobilized ankle Molded Ethafoam Foam Pad Provides optimal compression and pressure Good cushioning , enhances comfort Skin friendly Ergonomic design Light in weight - enhance compliance Bilateral symmetry - can be used for either ankle Neoprene sleeves - good cushioning ,reduce pressure of gripping straps One size fits all Molded splint with perfect anatomy Pleasing aesthetics Sleek can be used inside the shoe Effective immobilization. Ankle Splint Measurements Measure circumference approx 2 inches above the ankle joint. Size Chart - Size Inches CM Universal 7.2-12 18-30

What is HIPAA ? Compliance with the Health Insurance Portability and Accountability Act (HIPAA) is a core requirement of the stakeholders involved in health information. HIPAA has prescribed standards with which to protect critical data relating to patients. Electronic Health Records (EHRs) are important documents that contain sensitive patient data, and are thus considered Protected Health Information (PHI). Since this data is accessible to a number of players involved in the field of healthcare; it extremely important to set regulatory guidelines aimed at ensuring that patient information remains protected. HIPAA compliance is essentially about staying in compliance with these guidelines. Measures needed to show compliance with HIPAA HIPAA requires a healthcare organization dealing with PHI to implement all of the following measures and comply with them: Physical measures Network measures, and Process security measures The role of HIPAA Privacy Rule and HIPAA Security Rule HIPAA has set out two important rules that pertain to compliance. These are the HIPAA Privacy Rule and the HIPAA Security Rule. While the Privacy Rule relates to how the medical information of a patient is saved, accessed and shared; the Security Rule is about how to implement national security safeguards for protecting electronic PHI, or ePHI. Who all need to be HIPAA compliant? Since the aim of HIPAA compliance is to ensure complete safety of patient data, it has requirements for every stakeholder in the EHR process. These stakeholders comprise: Covered Entities (CE): Anyone involved in the treatment, payment and operations in healthcare Business Associates (BA): Any person who has access to patient information and is involved in supporting treatment, payment or operations. These include third-party administrators and private sector vendors Those with whom BA's work, or those that are called subcontractors Hosting providers. These typically include healthcare software pro

A Hospital Incident Command System is a wonderfully effective system for handing disasters and emergency situations: A Hospital Incident Command System is an absolute must for hospitals when they have to carry out unforeseen emergencies. Having a process-oriented Hospital Incident Command System is an effective tool for dealing with situations and saving lives. A Hospital Incident Command System (HICS) is a standardized process that helps hospitals deal with emergencies, natural or manmade. HICS is common across hospitals in the US and have common terminology and organizational structure. It is a single system that all hospitals have to use. Since emergencies can happen at any time and can be of any gravity; it is imperative for physicians to have a command of how to deal with emergencies by understanding the Hospital Incident Command System and its role in disaster situations. HICS goes beyond patient care. Physicians and other staff need to both have access to disaster-specific and related information to the Hospital Incident Command System, as well as know how to handle it, in order to bring about an effective response and augment an existing one. Advantage of having a Hospital Incident Command System The biggest advantage of having a Hospital Incident Command System is that its practices and processes are similar to those used by external agencies in times of emergency. This makes sharing incident command systems that much more effective and easier to coordinate, and facilitates information flow. Features of a Hospital Incident Command System A Hospital Incident Command System provides a flexible reporting structure with defined roles and responsibilities It sets up and facilitates communication flow and documentation protocol It provides the hospital operations a concrete strategic direction-oriented support by leveraging and optimizing additional resources such as staff and equipment, so that these are used where they are needed the most. A Hospital Incident

Overview: Do you know the steps that going into making new clients aware of your practice? From the first time they become aware of you brand, every step you take and every interaction along the way is more important than you know! Learn how to keep your customers coming back for more and singing your praises to those that matter, as well as a surefire formula to make sure your marketing dollars are working as well as you think they are! (Hint: We'll be GIVING YOU the formula to use from here on out!) Areas Covered in the Session: Each step of the customer acquisition, retention and upsell process Formula to determine the ROI of marketing expenses Who Will Benefit: Medical Practice Owners Managers Marketing Associates Speaker Profile Mara L. Shorr BA, MBM-C, CAC I-VIII is the founder and managing partner of The Best Medical Business Solutions, a Florida-based medical practice consulting firm assisting practices with their operational, administrative and financial health. Jay served as the Vice President of Operations and Practice Administrator for a leading Board Certified Dermatologist and Cosmetic Surgeon in South Florida until her passing in June 2012, and is currently a partner in a leading South Florida plastic surgery center and medspa. A Temple University graduate, Jay has served as a professional motivational speaker for nearly a dozen industry organizations, including the American Academy of Cosmetic Surgery, THE Aesthetic Show, The Aesthetic Academy, The Medical Entrepreneur Symposium, the American Academy of Facial and Reconstructive Plastic Surgery, the American Academy of Anti-Aging Medicine, the American Academy of Cosmetic Surgery, Vegas Cosmetic Surgery and Global Aesthetics, and more! In addition, he is a Certified Medical Business Manager from Florida Atlantic University. He is a Certified Medical Business Manager (CMBM) from Florida Atlantic University and a Certified Aesthetic Consultant (Levels I-VII) from The Aesthetic Practice Associa

Overview: In 2013, The US Department of Health and Human Services made major changes to rules implementing The Health Insurance and Portability Act of 1996 (HIPAA) and Health Information Technology for Economic and Clinical Health Act of 2003 (HITECH). Among the many areas impacted by these rules (billing, marketing, research, IT security, etc.) is fund raising. The amendments significantly modify the methods and practice that hospitals, their institutionally related foundations, and other healthcare charities may or must employ when using ANY patient or client information for fund raising. The webinar will cover how to effectively implement the fund raising regulations in a manner that increases both opportunities for philanthropic support and compliant implementation of the new mandates. The rules include specific operational requirements, some of which prohibit protocols that were required under the original HIPAA regulations. The "magic words" mandated by HIPPA-related regulations changed in multiple areas. The webinar will cover all of these areas to ensure your organization is both legally compliant and operationally effective. The types of information that may be used for fund raising changed significantly. This presents numerous substantial fund raising opportunities, as well as challenges on the use and storage of such information. Among other areas to be presented are The required method for individuals to opt-out of receiving fund raising communication The methods of informing patients and clients of their right to opt-out from receiving fund raising communication The broadly expanded types of fund raising communication subject to opt-out rights How providers, hospital, and related fund raising foundation apply an opt-out election by an individual The type of patient and client information that health charities may use for fund raising The contents of provider's Notice of Privacy Practice How clinicians can assist both their patients/clients and the

Cast saw devices are efficient, versatile power tool used primarily to remove orthopedic cast plaster. Unlike a regular circular saw with an adjustable blade designed to cut wood, a cast saw utilizes a straight, sharp blade spinning or vibrating quickly back and forth across a narrow angle to cut hard material. The blades are most often used with an orthopedic cast spreader attached to the machine. With the cast spreader attached to the machine, the operator simply places the cast in the center of the spread and begins the vibrating action. The speed and depth of the material being cut vary according to the operator's preference. Modern cast saw devices date back to the plaster cast cutting saw. Homer H. Stryker, an orthopedic surgeon in the U.S. submitted the patent for this device in April 1945. The cast saw consists of a blade and a cutting block. To cut materials without using vibrations, the blade must be slightly bent. An arbor blade assembly provides for a stable framework on which the blade of the saw blade can be placed. Power corded models of cast saw devices require a separate power cord to operate. This cord usually plugs into a standard wall outlet. Read more @ https://coherentmarketinsights-cmi.blogspot.com/2021/03/electric-cast-saw-devices-offer-various.html

eClinical solutions are used to improve the clinical development process through data analysis and management. It offers clinical and operational data by providing data management software and customized data management services, including clinical reporting, electronic data capture, data management and standardization, and clinical data repository platform, with total transparency. eClinical solutions allow users to standardize, integrate, manage, and analyze all their clinical and operational data with the help of integrated advanced visualization and analytical capabilities. Moreover, eClinical software help users to comply with budgeting, investigator management, patient management, government regulations, and adverse event reporting system among others. eClinical solutions integrate electronic health records, eTechnologies, electronic consent forms, clinical data management systems, and electronic data capture. Moreover, they are helping researchers in lengthy clinical research processes through proper management. eClinical solutions have gathered substantial market proposition among pharmaceutical and biopharmaceutical companies for streamlining their clinical trials and insights discovery across various phases from I to IV. Read more @ https://coherentmarketinsights-cmi.blogspot.com/2021/01/eclinical-solutions-help-reduce-human.html

Cognitive computing materials refer to computer-based technologies that use machine learning algorithms to emulate how the human brain operates. Eventually, this emerging technology will facilitate the production of artificially intelligent computer systems that are capable of resolving issues without the aid of human assistance. One very exciting use for these artificially intelligent software programs is the development of new businesses. Cognitive computing is particularly useful for assisting humans in the business domain such as those in finance, supply chain management, customer service, and product development. The key challenge in implementing artificial intelligence or cognitive computing technologies is to create a system that can work without direct interaction from humans. For instance, the data analysis systems used by banks are able to operate even without the presence of bank employees. The banks have now leveraged the power of artificial intelligence to make their analytical work much faster and more efficient. In the near future, self-driving cars with artificially intelligent drivers will be seen in the streets of our cities, allowing individuals to commute safely between points. Read more @ https://coherentmarketinsights-cmi.blogspot.com/2020/12/cognitive-computing-materials-are-being.html

Healthcare organizations require effective management of inpatient and outpatient departments. It is essential to efficiently manage this flow, in order to ensure smooth functioning of the organization. Patient flow management solutions are one such application that enables hospitals and healthcare organizations to effectively improve the patient flow, quality of care, resource optimization & utilization, and also reduce operational cost. In hospitals, it has become extremely crucial to avoid overcrowding in emergency departments also inefficient scheduling in surgical departments. Patient flow management solutions offer certain strategies to handle and improve patient flow. One of the first things that need to be done is to establish an emergency department fast-track process, which will be integrated with tests, triage, and treatment protocols. This will streamline patient handoffs. There should be a selective surgical schedule to help relieve strain on post-operative departments. Read More @ https://coherentmarketinsights-cmi.blogspot.com/2020/11/patient-flow-management-solutions-are.html