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Setting up a compliance program in healthcare: Organizations that set up a compliance program in healthcare should go by many voluntary regulations from the OIG, apart from those mandated by HIPAA. Setting up a compliance program in healthcare is about being compliant with standards. This entails having to be compliant with several standards, which cover a wide variety of areas. There are several voluntary and mandatory guidelines from the Office of the Inspector General (OIG), apart from standards from HIPAA. Setting up a compliance program in healthcare meeting HIPAA requirements is set out and mandated by the Patient Protection and Affordable Care Act (PPACA). Guidelines from the Office of the Inspector General (OIG) The series of compliance program guidance documents from the OIG are largely voluntary, and are meant for the different sections of the health care industry. These include Hospitals Nursing homes Third-party billers, and Durable medical equipment suppliers. These guidelines are issued with the intention of motivating healthcare units to develop and use their own internal controls aimed at helping them adhere to regulations, program requirements and statutes. The OIG issues documents, which act as guidelines for setting up a compliance program in healthcare by providing principles. These need to be adapted when healthcare organizations have to develop their own compliance program that is in tune with their best interests and needs. Another major aim is served in the implementation of these guidelines for setting up a compliance program in healthcare: They help healthcare units to understand the nature of fraud and other risks associated with abuse, when they are setting up a compliance program for their healthcare unit. HIPAA requirements Setting up a compliance program in healthcare while being compliant with HIPAA regulationsrequires a healthcare organization to put in place measures that ensure that health records must: Be confident

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

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

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

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

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 "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

Overview:  Emotionally difficult or painful conversations are very common in health care. Consequently, it is quite remarkable that health care training programs do not spend more time teaching future health professionals the kinds of emotional and relational skills that are often required in these kinds of patient-provider interactions. This presentation will discuss the architecture of the painful conversation by examining : Its effect on the professional's sense of self and especially his or her need to preserve self-esteem The critical role of feelings and emotions, and The nature and value of empathy. The latter half of the presentation will consist of various strategic and practical recommendations so that emotionally challenging conversations might be conducted artfully, especially with "difficult" or "impossible" patients. Areas Covered in the Session: By the end of this presentation, learners will be able to: Relate the painful conversation to their construction of their professional "self"; Explain how an ability to control one's feelings can influence the success or failure of an emotionally difficult conversation; List a number of empathic responses that are useful in conducting difficult conversations Who Will Benefit: Any health professional who has to communicate with others. Speaker Profile John D. Banja is a Professor in the Department of Rehabilitation Medicine and a medical ethicist at the Center for Ethics at Emory University. He also directs the Section on Ethics for the Atlanta Clinical and Translational Science Institute at Emory. Dr. Banja received a doctorate degree in philosophy from Fordham University in New York and has taught and lectured on topics in medical ethics throughout the United States. He has authored or coauthored over 200 publications and has delivered over 800 invited presentations at regional, national, and international conferences. He currently serves as the Editor of the American Journal

In the business world as well as in the healthcare field growth is good. However, with growth comes a unique challenge; which may or may not be solved. Even though an evolving or growing medical facility services may not change, the internal processes related to claims submission, income cycle, billing and coding and revenue cycle management need a serious overhaul in order to stay efficient and sustainable as they scale up the operation.

This Women's day take a step for yourself - beyond celebrating the day, celebrate the woman in you. Why that self care is always limited to time for most of the woman? Every one of you are told that you deserve the best but do you really spare to give yourselves the same?

Scientific Regulatory writing is a complex process due to its dossier size, data complexity, and submission deadlines and it requires specialized domain-specific knowledge, understanding of drug development process, pharmacology, statistical and writing skills to develop superior regulatory documents as per the exact requirements of the regulatory authority. Besides, the scientific writer must be familiar with technical guidelines prevailing in countries like European Union (EU), USA, Japan that includes ICH E3 to write clinical study reports, periodic safety reports (ICH E2C), publication guidelines (e.g. CONSORT, STROBE, PRISMA), the International Committee of Medical Journal Editors (ICMJE) guidelines for manuscripts.

Platelet-rich plasma is a coagulated blood-rich polymer, made from extracted platelets. Extracted platelets are normally coagulated by monocytes or lymphocytes with fibrin. Platelets are also commonly injected into the body's bloodstream to support tissue healing following tissue surgery. Platelet-rich plasma has been found effective against bleeding disorders. It also helps reduce the risk of deep vein thrombosis (DVT) in patients with high blood pressure and in those taking anticoagulants. It may also reduce the risk of pulmonary embolism (PE), which is blood clots that enter the lungs and pulmonary system. In the chest, the clot can stop or limit the flow of blood to the heart. PE often leads to cardiac arrest and death. Increasing cosmetic surgeries is expected to drive growth of the global platelet rich plasma market during the forecast period. Cosmetic surgeries refer to surgical specialty involving the restoration, alteration, or reconstruction of the human body. According to the International Society of Aesthetic Plastic Surgery (ISAPS), in 2018, around 128,398 cosmetic procedures in Thailand and 1,036,618 procedures in Mexico were carried out. Hence, these factors are expected to drive growth of the global platelet rich plasma market during the forecast period. Furthermore, increasing prevalence of cosmetic surgeries is expected to boost the global platelet rich plasma market growth over the forecast period. Read more @ https://sachinbhombe.blogspot.com/2021/03/platelet-rich-plasma-market-is-witness.html

Anti-counterfeit packaging solutions such as radio-frequency identification (RFID), forensic techniques, 2D barcodes, holograms, and more are used to protect customers from counterfeit products. Secure packaging plays a key role in preventing the counterfeiting of any product. Anti-counterfeiting packaging provides a secure and safe packaging solution to the product, in order to eliminate infringement and counterfeiting. Stringent laws and regulations enforced by governments are expected to drive growth of the global anti-counterfeit packaging market during the forecast period. The government of many countries has enforced stringent regulations and laws to curb the counterfeiting of products. Furthermore, in September 2020, the International Trademark Association (INTA) announced to step up its efforts to combat counterfeit products with new laws under consideration. Moreover, in December 2019, in the U.S., the SANTA Act (Stopping All Nefarious Toys in America Act) was introduced that set requirements for online marketplaces selling toys to verify seller information and disclose it to consumers. Read more @ https://sachinbhombe.blogspot.com/2021/03/anti-counterfeit-packaging-market.html

Autoclaves are also known as steam sterilizers and are used to expose each item to direct steam contact at the required temperature and pressure for the specified time. They are used for healthcare or industrial applications to eliminate the protein structure of the bacteria and spores. Compatible of steam autoclaves for crisis strategy decontamination of N95 respirators is expected to propel growth of the global steam autoclave market. For instance, in October 2020, 3M, a U.S-based multinational conglomerate corporation, announced that Belimed steam autoclaves are compatible for crisis strategy decontamination of specific single-use N95 Respirators. Moreover, launch of biological indicators for steam autoclaves is also expected to aid in growth of the market. For instance, in December 2020, Steris Corporation, a U.S-based medical equipment company, launched Spordex Self-Contained Biological Indicator Ampoules to confirm sterilization of liquids in steam autoclave cycles. Emergence of Covid-19 is expected to offer lucrative growth opportunities for players in the global steam autoclave market. For instance, globally, as of 4:03pm CET, 1 March 2021, there have been 113,820,168 confirmed cases of COVID-19, including 2,527,891 deaths, reported to the World Health Organization. Moreover, high prevalence of hospital-acquired infections is also expected to aid in growth of the market. For instance, according to an observational epidemiological study of intra-abdominal infections published in December 2019, in NEJM Journal Watch, of the 2621 critically ill adults with intra-abdominal infections at 309 international centers between January and December 2016, 32% were community-acquired, while 68% were hospital-acquired. Read more @ https://coherentmarketinsights-blog.blogspot.com/2021/03/emergence-of-covid-19-and-lunch-of-new.html