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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

Overview: This webinar will focus on the major fraud and abuse laws, including the Stark Law, the Anti-Kickback Statute, and the False Claims Act. In this webinar Mr. Wolfe will provide an overview of the health care regulatory issues related to implementing value-based physician compensation models. Why should you Attend: Given the substantial awards and settlements in recent Stark Law enforcement actions, Stark Law compliance has become more than just a compliance issue: it is an enterprise risk management issue. As medical groups, hospitals, and health systems transition to value-based physician compensation arrangements, they will need to make sure their arrangements continue to be compliant with the Stark Law. Areas Covered in the Session: Provide a general overview of the Stark Law, Anti-Kickback Statute and the False Claims Act. Explain the requirements for compliance with key regulatory exceptions and safe harbors. Compensation and valuation issues unique to the group practice model Discuss best practices when implementing value-based physician compensation models. Summarize the recent changes to the Stark Law for 2016. Who Will Benefit: In-House Counsel Health Care Compliance Officers Health Care Human Resources Health Care CFOs Health Care executives Speaker Profile Joseph Wolfe is an attorney with Hall, Render, Killian, Heath & Lyman, P.C., the largest health care focused law firm in the country. Mr. Wolfe provides advice and counsel to some of the nation's largest health systems, hospitals and medical groups on a variety of health care issues. He regularly counsels clients on a national basis regarding compliance-focused physician compensation and alignment strategies. He is a frequent speaker on issues related to the physician self-referral statute (Stark Law), hospital-physician transactions, physician compensation governance and health care valuation issues. Before attending law school at the University of Wisconsin, he served as a combat engi

Overview: This webinar is designed for medical practice leaders to gain a working knowledge of the Value-Based Modifier program and how your cost and quality metrics will be used to determine your Medicare payments in future years. Why should you Attend: Your future Medicare payments are at risk. 2018 payment rates may be cut up to 6% if you fail to report quality measures to CMS for the 2016 calendar year. Your practice can also see cuts of 1-4% if you are an outlier on costs or quality. On the other hand, practices that show they are significantly better than average on costs and/or quality can receive an increase over the standard Medicare payment rates. You'll want to understand how this program works, what the potential impact for your practice is, and what steps you need to take now to ensure success in 2018. Areas Covered in the Session: What types of medical practices are impacted by the VBM program and how much is at risk for practices of different sizes. What cost and quality metrics are used and how are they combined to yield your practice's future payments What are the timelines for submitting data and reviewing your status What actions you can take now to ensure the highest possible Medicare payments in future years Who Will Benefit: Practice Administrators Physicians, Podiatrists, Physician Assistants, Nurse Practitioners, CRNAs Quality Officers Nurse leaders Finance Directors Speaker Profile Jeanne J. Chamberlin Jeanne Chamberlin is currently a Practice Management Consultant with MSOC Health. During her 30 years in the healthcare industry, Jeanne has worked in independent medical practices, health systems, state government, and software development. She holds a Masters Degree in Public Policy from Duke University and is a fellow in the American College of Medical Practice Executives. She has been a leader in both state and local MGMA chapters. As practice administrator of a 10-physician multi-specialty practice, Jeanne first began

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

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

Overview: This webinar will cover the changes to the PQRS program in 2016 and will provide tips and strategies to help you select the best measures and reporting approach for your practice. Why should you Attend: Your future Medicare payments are at risk. Failing to report quality measures to CMS for Calendar Year 2016 will result in a reduction of up to 6% in your 2018 Medicare payments. The PQRS program carries a potential 2% penalty for each provider who does not report quality measures to CMS - physicians, mid-level providers, therapists, psychologists, social workers, even dieticians. In addition, if your practice has physicians and mid-levels, at least half the physicians must meet the PQRS requirements or the group will face an additional 2-4% penalty from the Value Based Modifier program. Areas Covered in the Session: Understand the difference between a reporting rate and a performance rate? Get access to useful tools to help you identify measures applicable to your specialty. Learn how to choose among the various reporting approaches - what are the pros and cons of each. Understand how CMS will evaluate your submission if you report less than 9 measures. Who Will Benefit: Practice Administrators All providers who bill to Medicare including Physicians (All specialties), Podiatrists, Physician Assistants, Nurse Practitioners, Psychologists, LCSW, Physical and Occupational Therapists, Speech/Language Pathologists, etc. Quality Officers Nurse leaders Finance Directors Speaker Profile Jeanne J. Chamberlin Jeanne Chamberlin is currently a Practice Management Consultant with MSOC Health. During her 30 years in the healthcare industry, Jeanne has worked in independent medical practices, health systems, state government, and software development. She holds a Masters Degree in Public Policy from Duke University and is a fellow in the American College of Medical Practice Executives. She has been a leader in both state and local MGMA chapters. As practice ad

Overview: This webinar is designed for medical practice leaders to gain a working knowledge of the Value-Based Modifier program and how your cost and quality metrics will be used to determine your Medicare payments in future years. Why should you Attend: Your future Medicare payments are at risk. 2018 payment rates may be cut up to 6% if you fail to report quality measures to CMS for the 2016 calendar year. Your practice can also see cuts of 1-4% if you are an outlier on costs or quality. On the other hand, practices that show they are significantly better than average on costs and/or quality can receive an increase over the standard Medicare payment rates. You'll want to understand how this program works, what the potential impact for your practice is, and what steps you need to take now to ensure success in 2018. Areas Covered in the Session: What types of medical practices are impacted by the VBM program and how much is at risk for practices of different sizes. What cost and quality metrics are used and how are they combined to yield your practice's future payments What are the timelines for submitting data and reviewing your status What actions you can take now to ensure the highest possible Medicare payments in future years Who Will Benefit: Practice Administrators Physicians, Podiatrists, Physician Assistants, Nurse Practitioners, CRNAs Quality Officers Nurse leaders Finance Directors Speaker Profile Jeanne J. Chamberlin Jeanne Chamberlin is currently a Practice Management Consultant with MSOC Health. During her 30 years in the healthcare industry, Jeanne has worked in independent medical practices, health systems, state government, and software development. She holds a Masters Degree in Public Policy from Duke University and is a fellow in the American College of Medical Practice Executives. She has been a leader in both state and local MGMA chapters. As practice administrator of a 10-physician multi-specialty practice, Jeanne first began working wi

Baby monitors with camera and wireless baby monitors is a superb value monitors available with panic button and many other features. Baby monitors provides two-way communication and have become ever more sophisticated to give peace of mind to Mum and Dad.

The Department of Industrial Policy and Promotion (DIPP) has released a statistic affirming Foreign Direct Investment in the region of pharmaceuticals and drugs. The value of investments will be around US $ 8.81 billion that comes to about Rs 48,828.3 crore in Indian currency. It is predicted that, the biotechnology industry will surpass 11.6 billion dollars by the year 2017

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

Overview: As the healthcare industry moves toward a value based reimbursement model rather than fee for service, it is crucial that the provider and ancillary staff understand how ineffective reporting can lead to dollars lost. We will review the 3 critical areas that require skilled management. Understand that patients are more educated about their healthcare and are increasingly responsible for more out of pocket costs. High dollar deductibles may result in self pay realities and bad debt increases. Learn areas that increase your chances for an audit. Are you ready for the challenge? Why should you Attend: Revenue is dependent upon proficiency in multiple areas. In today's environment, it is risky to maintain the status quo and increasingly important to obtain and maintain skilled business staff. The granularity of the ICD-10 code set requires understanding of the official coding conventions and guidelines, the ability to apply those guidelines, and the ability to recognize when reporting may lead to revenue delay, reduction or loss. Additionally, other factors affect your revenue stream. This includes patients with high deductible plans, collection of much more than a small co-pay, and staff understanding of regulations that govern telephone collection activity. Don't leave money on the table or invite an audit into your practice. Audits are often the result of weak billing and coding skills. This program will review several areas that will cost you money if poorly handled. Areas Covered in the Session: Required specificity in coding Documentation necessary for ICD-10 reporting Why coders must frequently query for clarification How ambiguous diagnosis reporting affects you r bottom line Internal collections versus outsourcing. What should you consider Staff effective in handling problem claims? Developing appeals? Who Will Benefit: Coders Billers Revenue cycle Physicians Mid-level providers Nurses Claims follow-up Managers Managers Speaker Profil

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

Healthcare fraud and abuse: Healthcare fraud and abuse are different but related kinds of malpractice. They affect everyone concerned: the patient, the healthcare unit, the healthcare sector, and eventually, the economy. Healthcare fraud and abuse are serious malpractices that can have very grave consequences for the patient, the hospital and the healthcare sector. They can also cost taxpayers heavy amounts of money. Healthcare fraud: There is some distinction between healthcare fraud and healthcare abuse. Healthcare fraud is said to happen, according to medicare.gov, when Medicare gets billed for a service or supply the end user never gets. These fraudulent claims result in loss of billions of dollars of revenue to Medicare each year. Healthcare fraud could be said to happen when: False statements are submitted knowingly or facts are misrepresented with the purpose of obtaining a federal health care payment for claims for which the person is not entitled A person knowingly solicits, pays, or/and accepts a payment with the intention of inducing or rewarding referrals for services or items that any of the federal healthcare programs reimburse Eligibility is falsified Prohibited referrals are made for select, designated health services Healthcare abuse: Although related, healthcare fraud and abuse are not totally similar to each other in spirit. A healthcare abuse can be when physicians do not comply with or bypass established good medical practices or administer treatments that are not necessary. This is less serious than fraud in terms of intent, but carries the same consequences: loss of billions of dollars to the exchequer and potential damage the patient's health and the physician's and/or healthcare provider's reputation. Some examples of healthcare abuse These are some of the examples of healthcare abuse: When services that are not medically warranted are performed and charged for When services and/or supplies are charged in excess of their actual value

Overview: Safe hospital care in neither a science nor an art. It is a practice just like the practice by a doctor who combines hindsight of experience and foresight of imagination to come up with an outsight of the best interventions and best protocols. Over time the doctor standardizes the process but is vigilant to any unique requirements of each patient. Such an approach in patient safety is called hazard analysis and mitigation process. This webinar goes a big step farther. It covers innovation strategies to assure that the safety improvements result in a high return on investment and high value to the hospital, and protects the patients. Why should you Attend: About 400,000 patients die each year from hospital mistakes according to a senate hearing. Evidence based methods to reduce adverse, sentinel, and never events are available and successful in aerospace, nuclear, and chemical industries. Why not use them? We need a paradigm shift. We need it in a hurry! You cannot cross the sea merely by standing and staring at the water. Do not be afraid to take a big step if one is indicated. No noble thing can be done without risks Areas Covered in the Session: The Etiologies of Unsafe Care Sufficient Understanding is a Pre-requisite to Safe Care Preventing "Indifferencity" to Enhance Patient Safety Continuous innovation is better than Continuous Improvement Innovations Should Start with Incidence Reports Hazard Analysis Fault Tree Analysis-the Best Tool for Harm Prevention Doing More with Less is Innovation Re-Invent Quality Management Human Errors may be Unpreventable, Preventing Harm is an Innovation Managing Safety: Lessons from Aerospace Protect Patients from Dangers in Medical Devices The Paradigm Pioneers Aequanimitas,The Best Known Strategy for Safe Care Who Will Benefit: Hospital senior management Hospital administrators Doctors Nursing staff Clinical engineers Radiology staff Infection control staff Patient advocates Speaker Profile Dev Raheja

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

Overview: The Sunshine Act, or Open Payments Program, requires manufacturers of drugs, medical devices, and biologics that participate in U.S. federal health care programs to report certain payments and items of value given to physicians and teaching hospitals. This Act was part of a healthcare reform bill adopted in March 2010. It came about due to requests for increased transparency about the financial relationships between physicians and industry. The Centers for Medicare and Medicaid (CMS) issued the final rules in 2013 which implemented the Sunshine Act. Why should you Attend: Anyone required to adhere to the Sunshine Act standards or anyone interested in knowing what must be reported and made public. Areas Covered in the Session: Purpose of the Sunshine Act Who is required to report under the Sunshine Act? What is reported? Exclusions Tracking Penalties Useful links Who Will Benefit: This webinar will provide valuable assistance to all personnel in: Human Subjects Research Healthcare interested in exploring the field of Clinical Research Clinical Research Coordinators Principal Investigators/Physicians Administration in charge of Clinical Research Regulatory Compliance Speaker Profile Sarah Fowler-Dixon is Education Specialist and instructor with Washington University School of Medicine. She has developed a comprehensive education program for human subject research which has served as a model for other institutions. She crafted budgets, policies, procedures, reporting, and training for the new program. She has initiated the planning, development, authorship and implementation of many human subjects research policies, practices, guidelines, submission and reviewer forms often working with state and federal authorities. She has provided consultation regarding ethical, federal, state, and institutional requirements for faculty and staff both in the design and execution of their projects and teaches research ethics and regulatory affairs and the fu

Outline Value Based Healthcare System - How it is seen today Healthcare Challenge & IoT as a Solution IoT - Big Data Structure Recent Trends in IoT Big Data Analytics Challenges & Our Future In-depth Knowledge of What causes the most premature death? Distribution of Disease burden from 1990 - 2020 Challenges in Healthcare Future Healthcare IoT Machine Talking to Machine Prediction of IoT Usage About PEPGRA HEALTHCARE, A leading healthcare communication firm with years of excellence serving clients with a dedicated team of Medical, Regulatory and Scientific writers specialized in all therapeutic areas. Contact us at : UK: +44-1143520021 US/Canada: +1-972-502-9262 India: +91-8754446690 info@pepgra.com www.pepgra.com