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Roger Steven

Seminar on Effective and Efficient Internal and Supplier Quality System Auditing for Me... - 0 views

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    Course "Effective and Efficient Internal and Supplier Quality System Auditing for Medical Devices" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion. Overview: Do you want to understand how to do efficient and effective internal and supplier audits that meet all the requirements of your external auditors, but also add value to your company? Are you confused by all the requirements and guidance documents for medical device quality management systems and are tired of wading through all the regulatory language they contain. This course is for those who will do internal or supplier audits, manage an audit process for these or other company audits. This course will provide you with an easy to understand presentation on the auditing process as well as the requirements you will need to audit under ISO 13485 and the FDA Quality System Regulation (cGMP) Both FDA Quality System Regulation (QSR) and ISO 13485 require that companies do internal audits. However, because the FDA does not look at the content of internal audits, some companies do not get feedback on the true effectiveness of their internal audit system from the FDA during FDA Inspections. ISO 13485 auditors do look at internal audits, but are most concerned that you define a process that meets the requirements of the standard and are following your process. Both require that you define Auditor training is required, but this sometimes just requires reading the company's procedure, although most external auditors will look for more than this. Do you need to train new auditors for yours medical device quality management system or to audit your suppliers? Or do you need to improve the training of your internal and supplier auditors so that they add value to these audits? If you need to do either of these, this seminar will provide this training. In addition to auditing skills and hands-on auditing exercises, this seminar will provide an ove
Roger Steven

How to Ensure a Successful Health Care Systems Implementation - 0 views

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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
Roger Steven

Elements of an efficient Healthcare computer system implementation - 0 views

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    Elements of an efficient Healthcare computer system implementation Healthcare computer system implementation lies at the heart of a healthcare delivery information system. The processing and dissemination of information in extremely quick time is indispensable to healthcare, given the number of processes that go into the healthcare information system, and the improvement in care this can bring about. A healthcare computer system, which can be described as the ecosystem of a healthcare delivery information system, is thus a critical component, because this healthcare computer system implementation is what decides between the efficiency of a healthcare information system and lack of it. A healthcare computer system implementation should cover all the core areas that are part of a healthcare delivery information system, such as the patient, the caregiver, the medical records concerning the patient, the healthcare organization, and other aspects of administration, such as admission, billing and so on. What goes into an efficient healthcare computer system implementation? An efficient healthcare computer system implementation consists of taking into account all the major elements of a healthcare delivery information system. It should have the ability to synchronize, coordinate and integrate vital data from across departments and systems. An efficient healthcare computer system implementation should also take into account the technologies that go into them. Technologies keep changing rapidly. New ones come into being and render the old ones obsolete in no time. A healthcare computer system implementation has to take into account the nature of these changes, and should implement them in quick time. Technologies and technological tools that are doing the rounds today include the cloud, mobile technologies and the social media. So, a healthcare computer system implementation has to integrate these. In the particular context of the American healthcare system, healthca
Roger Steven

A Hospital Incident Command System is a wonderfully effective system for handing disast... - 0 views

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    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
Roger Steven

How to Ensure a Successful Health Care Systems Implementation - 0 views

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    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
Roger Steven

Preparing to Comply with the New FDA FSMA Rules Planning Valid Preventive Food Safety C... - 0 views

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

High Prevalence of Chronic Disorders to Augment Growth of the Global Nurse Call Systems... - 0 views

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    Nurse call system makes an all-in one solution for both your nurse call needs as well as wireless nurse phone calls. These systems have been some of the best in the market these days in that they can incorporate any old piece of hospital equipment into a single unified call center system. With an integrated system, you can now use your pager, digital radio, or even your cell phone to dial in, and you can get live access to your nurses through a large LCD screen. Nurses can use this system at the reception desk or even while on the job. For those who wish to be constantly on the go, the system also features an LCD screen with a large touch pad that makes it easy to navigate and input data. A digital radio, headset, and other necessary hardware are all included in the package for the best experience possible. There are many options to choose from in this type of system, depending on how much you want to spend. The biggest thing to consider is how much you need and whether you want a more basic system, or a more advanced system like a fully integrated one. Each system comes with a long warranty, so if ever there was a time when you needed a system to replace, you are covered. High prevalence of chronic disorders is expected to propel growth of the global nurse call systems market. For instance, according to the study, "Global and regional diabetes prevalence estimates for 2019 and projections for 2030 and 2045: Results from the International Diabetes Federation Diabetes Atlas, 9th edition", published in the journal Diabetes Research and Clinical Practice, in September 2019, 463 million people are expected to suffer from diabetes in 2019 worldwide and the number is expected to reach 578 million by 2030 and 700 million by 2045. Read more @ https://coherentmarketinsights-blog.blogspot.com/2020/12/high-prevalence-of-chronic-disorders-to.html
Roger Steven

Seminar on Validation and 21 CFR 11 Compliance of Computer Systems Intermediate to Adva... - 0 views

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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 /
Roger Steven

Seminar on Validation and 21 CFR 11 Compliance of Computer Systems: Intermediate to Adv... - 0 views

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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 / Senior
Roger Steven

Seminar on Supplier Management for Medical Device Manufacturers at Washington, DC - 0 views

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    Course "Supplier Management for Medical Device Manufacturers" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion. Overview: Supplier selection and management is one of the critical issues for medical device manufacturers. Suppliers provide materials and services to the device manufacturer, which means that they can be critical to performance and delivery of your device. Neither the FDA nor your notified body regulates your suppliers (with a few exceptions). They expect you to have an effective process to ensure your suppliers perform in the regulatory environment. How well do you understand the requirements for supplier management? Could you pass a regulatory audit or inspection without any issues? This course delivers the tools, templates, and methods to help participants implement an effective and efficient supplier management program. This two-day hands-on course provides a clear understanding of the underlying principles of supplier management. The course uses exercises to solidify understanding. In addition, the course uses FDA Warning Letters to illustrate the points and help you learn from others. As part of the practical implementation, the course includes receiving acceptance activities, outsourced processes, process validation at the suppliers' location, supplier auditing techniques, and supplier issues in management review. The course uses the Global Harmonization Task Force (GHTF) framework, but expands it to cover other issues and techniques important in effective implementation. Why should you attend: Since FDA regulations do not allow them to audit your suppliers unless they make finished medical devices, they require that you have sufficient control over them. But from time to time the FDA makes a reinterpretation of what this means. This happened within the last f 5 years, so if you supplier management program is older than that, you need to make major changes in you supp
Roger Steven

Analytical Instrument Qualification and Validation: Understanding to Prepare for FD... - 0 views

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

Rapid Growth of the Healthcare Industry to Augment the Practice Management System Marke... - 0 views

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    Practice management system helps manage the daily operations of an organization. The system helps organization (or facility) to settle meetings with specialists, record persistent information, keep up record, create last reports, etc. A medical practice management system provides staff members with real-time visibility into each patient's availability, enabling them to quickly identify potential scheduling problems. The system send email or text message (appointment reminders) to patients, reducing the possibility of a full-blown event that could negatively impact patient flow. Practice management system find wide application across various verticals in an industry. Increasing integration of healthcare system with practice management solutions is expected to propel the growth of the practice management system market. For instance, in January 2021, Brevium, an innovative SaaS company in the healthcare sector announced that it has extended the integration of its software with one of the premier electronic practice management systems in the U.S., Nextech. Moreover, rising incentives by federal government are also expected to foster the practice management system market growth. Read more @ https://coherentmarketinsights-blog.blogspot.com/2021/01/rapid-growth-of-healthcare-industry-to.html
Roger Steven

New HIPAA Rules - Meeting Requirements for New Patient Rights and New Restrictions on D... - 0 views

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    Overview: New changes modifying the HIPAA Privacy and Security Regulations are going into place to meet the privacy and security mandates within the HITECH Act in the American Recovery and Reinvestment Act of 2009. The changes include establishing new rights for individuals as well as changes to the limitations on uses and disclosures. New requirements for patient access to records and requirements to notify individuals in the event of a breach are only two of the many areas affected in the new law, including new requirements for restriction and accounting of disclosures and increased enforcement activity. Covered entities that use electronic health records (EHRs) will need to meet new access and disclosure rules and all kinds of business associates and their subcontractors will need to establish compliance programs. And if you are required to have a HIPAA Notice of Privacy Practices, you will need to update that to show all the new rights that patients will have, such as electronic copies, new rights to restrict disclosures, and much more. Business associates are now directly covered by the HIPAA privacy and security regulations and are liable for fines and penalties if they do not comply. If a business associate supplies services that interact with the new changes to the rules, the BA will need to be aware of the new requirements. We will explain what a Business Associate needs to do differently under the new regulations. Electronic records have new demands placed on them, in both providing access and in accounting for all disclosures of health information - the electronic age in health care brings new obligations to serve individuals as well as manage health information for healthcare professionals. We will discuss how disclosures must be tracked in an EHR and review the various ways patient records can be supplied electronically. The new regulations will be reviewed and their effects on usual practices will be discussed, as will what policies need to be chang
Roger Steven

Texting and E-mail with Patients Patient Requests and Complying with HIPAA - 0 views

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    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 understanding of not only the rules, but also how to think about compliance and make sound compliance decisions on a day-to-day basis in the context of mobile devices. Agenda Day One Day one sets the stage with an ov
Roger Steven

Science of Reliability for Patient Care - 0 views

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    Overview:   Institute for Healthcare Improvement (IHI) defines reliability as "failure-free performance over time2". This is simple enough to be understood by anyone. The aim is to have no failures over an extended time period in spite of variability in the patient environment. spite of variability in the patient environment.  This is in line with the technical definition of reliability as the probability of successful performance of intended functions for a specified length of time under a specified user (patient) environment. In a system where the severity of consequences is high, such as in hospitals, the goal is to achieve reliability as close to 100% as possible. This is called failure-free performance. Some hospitals have achieved this goal for specific medical procedures for several quarters. Can they extend this performance over years instead of quarters? That is the challenge we need to face and find elegant solutions zero mistakes or find a way to protect patients if a mistake cannot be prevented.  Why should you Attend: The failures of the U.S. healthcare system are enormous considering the severity of failures. As much as 400,000 patients die each year from hospital mistakes. Another 2.1 are harmed from nosocomial infections (infections acquired during hospital stay). The cost is in billions. Discussions with doctors show that there is reluctance to apply reliability principles to healthcare systems because the variability in healthcare is enormous compared to the aviation and industrial fields. Each customer (patient) is different and each illness is unique in its own way. Then there are interconnecting systems such as cardiology, gynecology, gastroenterology, emergency medicine, oncology, and patient data from various doctors, pagers, computers, vendor software, and intensive care, each operating independently most of the time. But good approaches to improving the system reliability have been tried and tested in many industries. There is a
Roger Steven

Seminar on Texting and E-mail with Patients: Patient Requests and Complying with HIPAA ... - 0 views

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    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
lifelinelab

 Tuberc - 0 views

  Tuberculous bacilli  was discovered  more than a 100 Years ago, however, it still remains a major health problem. Presently about 33 % of the world population is suffering from t...

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started by lifelinelab on 04 Dec 18 no follow-up yet
sachin_cmi

https://coherentmarketinsights-cmi.blogspot.com/2020/12/radiology-information-system-is... - 0 views

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    A radiology information system (RIS) is an integral part of the electronic management of imaging departments. It is a networked software system used for managing medical imagery and related data. It is typically useful in tracking radiology orders and billing information. Imaging informatics incorporates the application of sophisticated information technologies to deliver reliable, effective, and precise medical imaging services in a health care network. RIS is used in conjunction with digital x-ray computed radiography (CXR) and magnetic resonance imaging (MRI) to create digital images of the human body. This helps to prevent human error and to maximize the utility of diagnostic test results. The radiology information system provides end-to-end information technologies integration for diagnostic and clinical imaging laboratory work. RIS applications are used by radiology departments across the world and have made the workflow process smoother. There are several components that make up this system, including an EMR (Electronic Medical Information), an ERP (Electronic Product Data), a CRM (Customer Relationship Management Software), and a database. Read more @ https://coherentmarketinsights-cmi.blogspot.com/2020/12/radiology-information-system-is.html
Roger Steven

FDA New Electronic Data Capture Guidance - What is the impact on Inspectional Record Re... - 0 views

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    Overview: FDA 7348.811 section 1 states, "Regardless of the type of system used by the clinical site, the regulatory requirements for clinical data do not change whether clinical data are captured on paper, electronically, or using a hybrid system." What type of system is best for your program and investigator capabilities? The wrong choice yields inspectional non compliance. The right choice of electronic data capture, direct data entry, and data management depends on a sponsor assessment of the systems and procedures at the investigator site as compliant with FDA inspectional requirements. Additional source documentation procedures (origination, authorization, and signature) are required at the investigator site to address the electronic data capture process. It is these three FDA mandated inspectional criteria, applicable to every electronic data element, that generate most of the significant inspectional noncompliant findings. Some data elements are more likely to be associated with the findings of noncompliance than others. It is in fact difficult to determine which data requires or does not require original source documentation and what defines "original source documentation". Why should you attend: Investigators commonly assume that the new guidance and regulations reduce the need for source documentation in clinical trials. In fact, there are new procedural documents relevant to the electronic source documents and direct data entry that are required to comply with the current inspectional standards and the final guidance. Sponsor due diligence in choosing, training, and monitoring investigator sites to enable the use of compliant electronic data capture is required. Basic knowledge of part 11 and GCP requirements will be helpful in attending this advanced webinar. The focus will be on the additional FDA inspectional requirements for electronic data capture, and the impact of using electronic data capture on the seven FDA inspectional priority objectives
sachin_cmi

Pharmacy Benefit Management is an Integral Part of the Medicare System - 0 views

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    Pharmaceutical drug prices are rising and contribute significantly to total health expenditure worldwide. Since 2014, prescription drug prices have increased by 33%. In 2020, global spending on prescription drugs is expected to be US$ 1.3 trillion. Increasing drug prices and consumer spending on prescription drugs are increasing the demand for the pharmacy benefit management system. The system is operated by third-party administrators who act as a link between drug manufacturers, insurance providers, and pharmacists. The system assists in reducing drug prices by negotiating with drug manufacturers and retail pharmacies. Those who are enrolled in various health schemes and those without insurance can get the benefit of the pharmacy benefit management system. The system provides medicines at a lower price than those available at retail pharmacies. To reduce rising health expenses, Japan planned to start reviewing drug prices every year instead of every two years. The move reflects growing resistance to rising drug prices worldwide. In Europe, different approaches have been implemented to regulate drug prices. In Germany, manufacturers can freely set the prices of newly developed drugs during their first year on the market. Benefit assessments are done during this year and then used in price negotiations between manufacturers and the country's representatives of statutory health insurers. Read more @ https://coherentmarketinsights-cmi.blogspot.com/2020/12/pharmacy-benefit-management-is-integral.html
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