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Course "Verification vs. Validation - Product Process Software and QMS" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion. Overview: This course will review the company Master Validation Plan for major key inputs and CGMP deficiencies. It will address the FDA's newer and tougher regulatory stance. This course's aim is to prove "Product Risk Based V&V" by sufficient, targeted and documented risk-based V&V test case elements/scripts. It will teach participants to evaluate its elements against ISO 14971 and ICH Q9 for hazard analysis and product risk management. This course will evaluate different field-tested, U.S. FDA-reviewed V&V protocols; how to employ equipment/process Requirements Specs / DQs, IQs, OQs, and PQs, or their equivalents per ASTM E2500, all against a background of limited company resources. It will review a matrix that simplifies "as-product", in-product", process and equipment, et al, software VT&V, to assure key FDA requirements are not overlooked. While considering the QMS and 21 CFR Part 11; this course will make practical application of these same in two hands-on sessions. Why you should attend: This session helps participants: * Understand Verification and Validation, differences and how they work together; * Discuss recent regulatory expectations; * Know how to document a "risk-based" rationale, and use it in a resource-constrained environment; * Determine key "milestones" and "tasks" in a project; * Locate and document key subject "inputs"; * Compile "generic" Master and Individual Validation Plans; * Learn the key element of a Product V&V File/Protocol; * Understand how to develop Process and/or Production/Test Equipment V&V Files/Protocols; * Get a grasp of basic Test Case construction; * Understand sample sizes and their justification; * Learn the key elements of Software V&V expected by the FDA and how to document; * Deal with hardwa

Overview: Mental health care practitioners work in today's diverse, fast-changing, multidisciplinary health care environment. Nowhere but in mental health is there such diversity of clinicians who provide the same or similar services of counseling and therapy. A potential client has a wide choice of mental health providers from whom to choose. Yet each individual mental health profession has a unique education, training, and experience requirement for practice. While similarities exist, requirements differ from state to state and even from profession to profession with a single state. What are these requirements and how do they apply? The state's authority and power over mental health practitioners often presents challenges to these mental health professionals that are not easy to navigate. Differing sources of legal and ethical authority govern each respective health care practitioner in ways that are similar but not the same. Ethics and law are similar, but not the same. All mental health practitioners must adhere to standards of state law which govern their professional practices, including the very core of the doctor-patient relationship. Codes of ethics and state law may both apply to govern the conduct of this clinician. Even some state laws are referred to as ethical codes. Complaints as to alleged misconduct or ethical failings are received and investigated by a state agency and leave the mental health practitioner with an uncertain process to handle and to defend the state action against them. With this background, this seminar empowers the full understanding and application of ethics and laws for mental health practitioners. Learn to identify and understand an ethical framework for a sound mental health practice. An ethical framework is essential to having the right perspective to examine mental health dilemmas. Compare and contrast regulatory laws and codes of ethics to understand their differing applicability. Know the difference between laws and ethics,

Opioids agonist drugs are a group of powerful and widely used drugs that alleviate the pain of moderate to severe chronic pain by reducing the impact of narcotic receptors in the brain. These include both codeine and hydrocodone, the most common opioids. Although they relieve pain, they have serious side effects that include drowsiness, respiratory depression, dizziness, nausea, and sweating. These drugs are very powerful, so overdoses are common, and death from them is even more common. This group of drugs has received heavy criticism from both patients and doctors alike for the risks involved in using them. The opioid antagonist hydrocodone works by blocking the opioid receptors in the body. Codeine is the only opioid that does this in a pure form. Because hydrocodone blocks the opioid receptors in the brain, it becomes less available to people who take it. This opioid group is popular among heroin abusers, since heroin creates a euphoric state that cannot be reproduced with hydrocodone. For this reason, heroin abusers frequently turn to other forms of treatment, such as prescription medications and methadone. Other opioids agonist drugs in this group include oxycodone, hydromorphone (Percoset), hydromorphone hydrochloride (hydrocodone), and methadone. Taking them is not without dangers though. Oxycodone has caused at least five deaths and several dozen hospital admissions in the US since 1999. In extremely rare cases, people have died of overdosing on hydrocodone. Heroin abusers also regularly take this drug, since it can suppress their desire for heroin. Read more @ https://coherentmarketinsights-cmi.blogspot.com/2021/02/emergence-of-covid-19-and-increasing.html

Health Insurance Market Reforms under Obamacare: The Patient Protection and Affordable Act (PPACA), or Obamacare, sets out a number of provisions for health insurance market reforms. Having been set in motion in March 2010; the PPACA sets out health insurance market reforms that are being implemented in stages from dates commencing generally from January 1, 2014. PPACA's health insurance market reforms are aimed at health insurance standards and group health plans. These reforms set out dates for the implementation of these reforms. They also prescribe penalties for noncompliance with these reforms. What kinds of market reforms are needed? The health insurance market reforms suggested by PPACA are almost singularly for group health plans. A group health plan is defined as one in which the employer makes a contribution into expenses accruing from the employee's health insurance plans. When an employer chooses to bring an employee's health plan under her coverage; the employer has to mandatorily comply with the provisions of the health insurance market reforms. Areas of the health insurance market reforms: These are the essential areas in which the health insurance market reforms are to be applied: Removal of lifetime and annual limits on essential health benefits: One of the primary provisions of the health insurance market reforms under PPACA is that it prohibits both lifetime and annual limits on essential health benefits, which were allowed some dollar limits prior to enactment of Obamacare. Preventive health services: An area of preventive health services that has undergone an amendment under the health insurance market reforms is that of no-cost sharing. Accordingly, employer plans are to offer preventive health services without requiring the employee to share the burden for this part of the plan. The three-month waiting period: The health insurance market reforms don't require a waiting period of over 90 days. A waiting period is the period that has

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

The Physician Payment Sunshine Act: The Physician Payment Sunshine Act, also called Physician Payments Act, is a piece of legislation passed by the American Congress in 2010. It came to be enacted along with the Affordable Care Act, or Obamacare. The purpose of this legislation is to ensure transparency in the financial relationships that exist between the pharmaceutical industry, teaching hospitals, and physicians. What the Sunshine Act requires is this: Manufacturers of drugs and medical devices, and organizations that purchase in groups (Group Purchasing Organizations or PGO's) have to report payments or their equivalent that they make to physicians and teaching hospitals. Items that are considered equivalent to money payments, transfers of which have to be reported are clearly mentioned. These include the following: Meals Honoraria or grants Gifts Entertainment Speaking fees Writing services, such as research papers or manuscripts Travel reimbursements Purchase of items such as teaching materials and journals, which are paid either directly to physicians or teaching hospitals, supplied either directly or through a third party Funding for research Another core reporting requirement: Another requirement of the Sunshine Act is that when manufacturers of drugs and medical devices and group purchasing organizations have physicians who have a stake in some or another form in their organizations; this has to be reported to the Centers for Medicare and Medicaid Services (CMS). These reporting requirements apply to all kinds of physicians, who are either specialists or are general practitioners. However, the following are excluded from reporting by the Sunshine Act: Nurses Support and office staff Residents Medical students Physicians assistance Advance practice nurses Physicians need not report: The Sunshine Act requires information about these payments and transfers to be made by the paying medical device and drug companies, and not by physicians.

Course "Validation and 21 CFR 11 Compliance of Computer Systems: Intermediate to Advanced" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion. Overview: Computer Systems Validation (CSV) also known as Software Validation is all-pervasive in the Life Sciences Industry. It is a requirement of all the predicate rules, as well as 21 CFR 11 and Annex 11. However, unless one knows how to implement CSV, it is often very hard to detect the requirement for CSV, and very hard to determine what needs to be done, to meet domestic and / or international regulations or business continuity requirements. In addition, the FDA has stepped up 21 CFR 11 inspections that include CSV. This course will build on the Validation and 21 CFR 11 Compliance Basic Course, to give hands on experience on executing on the computer systems validation of a system, and to discuss related activities such as Validation Master Plan, Infrastructure Qualification, Project Management for Validation and Validation of Test Tools The attendees must have attended the Basic Validation & 21 CFR 11 Compliance. This is a very hands-on class and the attendees will be expected to use templates provided in the class to create the complete package for the validation of a system The Seminar: This Hands-On course will provide the attendees with more detailed experience on validation / 21 CFR 11 compliance of a computer system, as well as details for activities associated with computer systems validation as follows: 1. Validation Master Plan 2. Complete Validation for a System 3. Excel Spreadsheet Validation 4. Change Control 5. SOPs 6. Test Tools Validation 7. Project Management for Validation Who Should Attend : * VP of IT * Director of IT * Quality Managers * Project Managers (for CSV / IT) * Validation Specialists * Database Administrators * System Administrators * Directors / Senior Directors of Discovery * Directors /

Course "HIPAA for the Compliance Officer" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion. Overview: I will be going into great detail regarding you practice or business and how it relates to the HIPAA Security/Privacy Rule, Areas covered will be history of HIPAA, privacy vs security, business associates, changes for 2016, audit process, paper based PHI, HIPAA and suing, texting, email, encryption, medical messaging, voice data and much, much, more I will uncover myths versus reality as it relates to this very enigmatic law based on over 600 risk assessments performed as well as years of experience in dealing directly with the Office of Civil Rights HIPAA auditors. I will also speak to real life audits conducted by the Federal government (I've been on both sides of these audits) what your highest risks are for being fined (some of the risk factors may surprise you). In addition, this course will cover the highest risk factors for being sued for wrongful disclosures of PHI and the manner in which patients are now using state laws to sue for wrongful disclosures. Don't always believe what you read online about HIPAA, especially as it relates to encryption and IT, there are a lot of groups selling more than is necessarily required. Why you should attend: This lesson will be addressing how practice/business managers (or compliance offers) need to get their HIPAA house in order before the imminent audits occur. It will also address major changes under the Omnibus Rule and any other applicable updates for 2016. There are an enormous amount of issues and risks for covered entities and business associates these days. I will speak on specific experiences from over 17 years of experience in working as an outsourced compliance auditor, expert witness on HIPAA cases, and thoroughly explain how patients are now able to get cash remedies for wrongful disclosures of private health information. More im

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

From comprehension medicinal language to encountering "scanxiety," entering a growth place surprisingly can overpower. For youthful grown-ups beginning to set up their autonomy, the experience can be particularly scary. Having a care group you know and trust, and looking for psychosocial bolster through advising or care groups, can help numerous patients modify amid this troublesome time.

Mobile phone and wireless health applications

In this article we covered Flu Symptoms And Home Remedies. Influenza is a common respiratory illness that affects people from all age groups. Flu symptoms include a runny nose, sore throat, catarrh, and headache. Home remedies for flu are being used for centuries and have proven to be effective.

Influenza is a highly contagious, respiratory illness that affects people from all age groups and geographic backgrounds. In temperate regions, it occurs mostly in the winter months. There is no clear seasonal pattern in tropical climates. It varies in its severity from person to person. Sometimes, it presents as a mild, temporary infection. Other times, it can cause complications like red urine and ultimately lead to death. Influenza causes approximately 375,000 deaths worldwide each year.

Physicians Revenue Group Inc. offers revenue cycle management services in Houston. We help medical practices with effective claim submission approach to ensure fast reimbursements. Our revenue cycle management services in Houston help you to optimize revenue cycle process to achieve financial stability.

Course "New HIPAA Audit and Enforcement Activities: Being Prepared to Show your Compliance " has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion. Overview: We will be discussing the history and evolution of HIPAA Privacy/Security and the major points you need to understand to proactively protect your practice or business from the imminent federal auditing process: * History of HIPAA * HITECH * HIPAA Omnibus Rule * How to perform a HIPAA Security Risk Assessment * What is involved in a Federal audit and how is it conducted * Risk factors for a federal audit * How to avoid a Federal audit * Business Associates and HIPAA audits * EHR and HIPAA * Business Continuity/Disaster Recovery Planning * Assessing your contractors and sub-contractors * In depth discussions on IT down to the nuts and bolts * Risk factors that can cause an audit (low hanging fruit) * New rules which grant states ability to sue citing HIPAA on behalf of a patient * New funding measures Why should you attend : The evolutions of this enigmatic law and how what was once relative benign in terms of enforcement is now fully funded and aggressive. Learn what you can do to be prepared for an audit and how to lower risks of ever being audited. It is absolutely imperative that you are proactive and not reactive with your compliance program, this is a necessary evil and you need to protect your practice or your business and limit risks from the imminent Federal audits. Join me in keeping up with this very confusing law and take advantage of all the templates and information provided as part of the seminar. Areas Covered in the Session: * HIPAA -Brief History * HIPAA Privacy Rule vs HIPAA Security Rule * HITECH Act * Breach Notification Rule * Omnibus Rule and audits * Business Associates and audits * Current Court Cases (precedence) * Paper Based PHI Concerns and how to lower risk

Overview: Have you ever had a student who was excessively dramatic or who repeatedly monopolized discussions in a know-it-all, domineering, or aggressive fashion? Perhaps you've encountered a student who was so odd or anxious that they weren't able to participate in group activities or complete assignments. It's hard to know what to do when a student's personality just seems to take over your class, but you can't just stand by and do nothing. If they are not managed effectively, students with personality disorders take up a lot of time and can move your whole class in counterproductive directions. Sometimes these challenging students have a Personality Disorder, which is a persistent pattern of perceiving, relating to, and thinking about the environment and themselves that is maladaptive, rigid, pervasive, and enduring. Personality Disorders also manifest in the student's emotional response and impulse control and can negatively impact classroom teaching and learning as well as a student's personal and academic success. Unless you are a particular student's psychiatrist, it's not your job to diagnose them as having a personality disorder, but it is helpful to recognize and understand signs of a personality disorder. This webinar will identify different personality disorders and review their common traits and characteristics. You will learn essential tools for dealing with Personality Disorders such as boundary setting, clear communication, and effective classroom management. In addition, you will review relevant mental health resources and when and how to make appropriate referrals to counseling, accessibility services, and student conduct. Why should you attend: If students with personality disorders are not managed effectively, their behavior can have a negative impact on teaching and learning. Areas Covered in the Session: Ten types of Personality Disorders Prevalence and Demographics Developmental issues Common traits and characteristics of Personality Dis

Overview: This lesson is going to get back to the basics using multiple real life scenarios and "what if's". My goal is to make this very confusing and not well explained law easy to understand for the typical staff member. I will uncover myths versus reality as it relates to this enigmatic law based on over 1000 risk assessments performed as well as years of experience in dealing directly with the Office of Civil Rights HIPAA auditors. I will also point out multiple court cases I have been affiliated with where a staff member of a hospital or clinic has been sued or even imprisoned! I will also speak to real life audits conducted by the Federal government (I've been on both sides of these audits) what your highest risks are for being fined (some of the risk factors may surprise you). In addition this course will cover the highest risk factors for being sued for wrongful disclosures of PHI and the manner in which patients are now using state laws to sue for wrongful disclosures. Don't always believe what you read online about HIPAA, especially as it relates to encryption and IT, there are a lot of groups selling more than is necessarily required. Why should you Attend: Are you confused about HIPAA? Do you just want the basics and in plain English? Do you know there are civil and criminal penalties even for the rank and file staff member! Do you know what you can and can't do with protected health information? It is important to understand the new changes going on at Health and Human Services as it relates to enforcement of HIPAA for both covered entities and business associates as it relates to portable devices, texting, and emailing of PHI. You need to know how to avoid being low hanging fruit in terms of audit risk as well as being sued by individuals who have had their PHI wrongfully discloses due to bad IT practices. I have also been expert witness on multiple court cases where a business or medical practice is being sued for not doing their due diligence

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

Overview: This lesson will be going into great detail regarding your practice or business information technology and how it relates to the HIPAA Security Rule, in particular portable devices. Areas covered will be texting, email, encryption, medical messaging, voice data and risk factors as they relate to IT. I will uncover myths versus reality as it relates to this very enigmatic law based on over 600 risk assessments performed as well as years of experience in dealing directly with the Office of Civil Rights HIPAA auditors. I will also speak to real life audits conducted by the Federal government (I've been on both sides of these audits) what your highest risks are for being fined (some of the risk factors may surprise you). In addition this course will cover the highest risk factors for being sued for wrongful disclosures of PHI and the manner in which patients are now using state laws to sue for wrongful disclosures. Don't always believe what you read online about HIPAA, especially as it relates to encryption and IT, there are a lot of groups selling more than is necessarily required. Why should you Attend: HIPAA NOW HAS TEETH! Be prepared for what's new in 2016! Protect your practice or business! What factors might spurn a HIPAA audit? …are you doing these things? Why are the Feds enforcing after all these years? It is important to understand the new changes going on at Health and Human Services as it relates to enforcement of HIPAA for both covered entities and business associates as it relates to portable devices, texting, and emailing of PHI. You need to know how to avoid being low hanging in terms of audit risk as well as being sued by individuals who have had their PHI wrongfully discloses due to bad IT practices. I have also been expert witness on multiple court cases where a business or medical practice is being sued for not doing their due diligence to minimize risk. Areas Covered in the Session: Updates for 2016 BYOD Portable devices B