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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

Dextrin is a complex carbohydrate polymer in which one sugar molecule pairs with another through a peptide bond. The term comes from the fact that each sugar molecule has a double bond between the glucose and amino group. The sugar in the hexose sugars (glucose) and the forward bend of the double bond is called 'dextrin', whereas the non-amylated sugar is called 'xtrin' or simply 'x'. The purpose of this carbohydrate polymer is to create a complex, rather than simple sugar. Dextrin was initially developed to replace sucrose as a food supplement (in the food industry) and for medical purposes. Dextrin contains many similar properties to both glucose and maltodextrin and it was often used as an ingredient to replace sugar in diabetic diets (since diabetic diets typically do not contain the complex carbohydrates that provide the bulk of dietary fiber). Moreover, dextrin has the advantage of resembling both maltodextrin and glucose and many diabetics find that their oral medications contain dextrin instead of glucose Read more @ https://coherentmarketinsights-cmi.blogspot.com/2020/12/dextrin-has-similar-properties-to-both.html

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

Quality Management in Healthcare: Quality management in healthcare is a critical requirement for healthcare organizations. Making quality management patient-centric comes first. Adapting and implementing standards and tools is the next step towards this. Quality management in healthcare is of critical importance to the healthcare industry and the patient. Everyone in the loop -from physicians to practitioners to support staff -needs to be aware of the importance of quality management in healthcare. The most basic purpose of imparting high quality management in healthcare is to make sure that the patient is well taken care of. For this to happen, the healthcare setting has to implement systems and processes. Quality management centers on process management. If organizations have to ensure that meaningful quality management in healthcare is being implemented; they have to adhere to processes. Adapting standards and instilling processes into the healthcare system is how healthcare providers can assure quality in healthcare. Patient is at the center of quality management in healthcare Obviously, the first step in the direction of implementing quality management in healthcare is to make the healthcare setting's care and processes patient-oriented and patient-centric. Quality management in healthcare begins with the patient and should be fully tuned to her needs. As patients' requirements and expectations vary over time; quality management has to keep upgrading itself to keep up with the changing needs and demands. In line with this, the following means can go a long way in ensuring quality management in healthcare: The healthcare setting has to identify goals for ensuring quality management in healthcare. Each department has to be given measurable goals to reach. Implementing quality standards goes a long way in ensuring that quality management in healthcare is imparted in the organization. Six Sigma, ISO 9001 and ANOVA are some of the popular standards a

Quality Management in Healthcare: Quality management in healthcare is a critical requirement for healthcare organizations. Making quality management patient-centric comes first. Adapting and implementing standards and tools is the next step towards this. Quality management in healthcare is of critical importance to the healthcare industry and the patient. Everyone in the loop -from physicians to practitioners to support staff -needs to be aware of the importance of quality management in healthcare. The most basic purpose of imparting high quality management in healthcare is to make sure that the patient is well taken care of. For this to happen, the healthcare setting has to implement systems and processes. Quality management centers on process management. If organizations have to ensure that meaningful quality management in healthcare is being implemented; they have to adhere to processes. Adapting standards and instilling processes into the healthcare system is how healthcare providers can assure quality in healthcare. Patient is at the center of quality management in healthcare Obviously, the first step in the direction of implementing quality management in healthcare is to make the healthcare setting's care and processes patient-oriented and patient-centric. Quality management in healthcare begins with the patient and should be fully tuned to her needs. As patients' requirements and expectations vary over time; quality management has to keep upgrading itself to keep up with the changing needs and demands. In line with this, the following means can go a long way in ensuring quality management in healthcare: The healthcare setting has to identify goals for ensuring quality management in healthcare. Each department has to be given measurable goals to reach. Implementing quality standards goes a long way in ensuring that quality management in healthcare is imparted in the organization. Six Sigma, ISO 9001 and ANOVA are some of the popular standards a

Who doesn't want to look perfect? And if you don't have it naturally, take the help of your doctor. Going under the knife was once considered a taboo. There was always a hush-hush talk about it. But things have changed and so has the mindset, people are now more comfortable in accepting their flaws and making the necessary correction. Cosmetic surgery is a voluntary medical procedure that is performed on usual body parts with the sole purpose of correction or removing any signs of aging. Cosmetic or aesthetic surgery is a slight alteration of a body part which one is unhappy about.

Karma KM 2500 Small Wheel Wheelchair: Karma KM 2500 Small Wheel Wheelchair Specifications: Width 18" Front/Rear Wheels 6" to 14" Seat Width 47cm Seat Depth 40cm Overall Width 66cm Overall Collapsed Width 36cm Armrest Height 21cm Overall Length 90cm Seat Height 47cm Backrest Height 38cm Overall Height 86cm Weight 9.2 k.g. Karma KM 2500 Small Wheel Wheelchair Seat and Back: AEGIS Microbe Shield Approved by the FDA, EPA, EU, etc., bonded anti-microbial barrier upholstery protects from odor, staining and deterioration from bacteria, fungus and other microorganisms. It is a shield for your health. Karma KM 2500 Small Wheel Wheelchair Extended Armrest: By simulating the natural position of arms, the extended armrest design is ergonomic and creates bigger seating space. An Ultra lightweight wheelchair (9.2 kg) with a compact design for either attendant assisted or self propelling users. The use of aircraft-grade aluminium alloy and double cross brace provide this model with outstanding strength and durability. Karma Healthcare KM-2500 Premium Wheelchair is amazingly light and compact transit wheelchair which is ideal for outings and travelers. It folds down to take up virtually no space in the boot of a car and weighs just over 9.2 kg making it easy for anyone to lift into a vehicle. Backrest folds-down for easy transportation. Maximum user weight: 100 K.g. Aluminium frame. Fixed armrest/fixed footrest. Foldable frame via double cross bars. Comfortable & durable upholstery. Swing-away foot plates. Puncture proof tyres. Attendant cable brake. 14" flat-free rear wheels. Detachable and washable cushion. One Year Warranty. It folds down to take up virtually no space in the boot of a car. This amazingly light and compact transit wheelchair is ideal for outings and travelling. It comes with detachable and washable cushion. The wheel chair has attendant cable brake. It is made from aircraft-grade aluminium alloy fra

Course "The A to Z's of HIPAA Privacy, Security, and Breach Notification Rules" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion. Overview: This session is designed to provide intensive, two-day training in HIPAA compliance, including what's new in the regulations, what's changed recently, and what needs to be addressed for compliance by covered entities and business associates. The session provides the background and details for any manager of healthcare information privacy and security to know what are the most important privacy and security issues, 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. Who Will Benefit: * Information Security Officers * Risk Managers * Compliance Officers * Privacy Officers * Health Information Managers * Information Technology Managers * Medical Office Managers * Chief Financial Officers * Systems Managers * Legal Counsel * Operations Directors Agenda: Day One Day one sets the stage with an overview of the HIPAA regulations and then continues with presentation of the specifics of the Privacy Rule, recent changes to the rules, and the basics of the Security Rule Lecture 1: Overview of HIPAA Regulations * The Origins and Purposes of HIPAA * Privacy Rule History and Objectives * Security Rule History and Objectives * Breach Notification Requirements, Benefits, and Results Lecture 2: HIPAA Privacy Rule Principles, Policies and Procedures * Patient Rights under HIPAA * Limitations on Uses and Disclosures * Required Policies and Procedures * Training and Documentation Requirements Lecture 3: Recent and Proposed Changes to the HIPAA Rules * New Penalty Structure * New HIPAA Audit Program * New Patient Rights

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

A look at disruptive practitioner behavior policies: One of the very important factors needed for a healthcare unit to maintain its decorum and uphold its reputation is the implementation of disruptive practitioner behavior policies. The declaration and implementation of disruptive practitioner behavior policies goes a long way in ensuring that the hospital or healthcare center doesn't lose face. What are disruptive practitioner behavior policies? First, an understanding of disruptive practitioner behavior policies: Disruptive practitioner behavior policies may be termed as the putting in place in a healthcare providing unit a set of policies that are aimed at checking the errant and rude behavior of its staff members towards the patients and other people that use the services rendered by these centers. Who all carry out disruptive practitioner behaviors? Anyone in the healthcare setting can behave in an unbecoming and ungainly fashion with patients or those attending on them. Some of the typical types associated with disruptive practitioner behavior include shouting at them, bullying, intimidating, scolding loudly, being aggressive towards them, gesturing lewdly to them, and so on. This kind of behavior reflects very badly on the healthcare provider. Since there is intense competition in the healthcare providing industry; it is natural for patients to look for other centers when they face this kind of behavior. It is after all human to expect to be treated nicely. If one provider doesn't do that; patients look for other providers. Losing the patient, bad though it is, is not the only loss: When this becomes public, which is all the easier given the extensive reach of the social media; the healthcare unit's name goes for a toss. The role of disruptive practitioner behavior policies It is to curb this kind of behavior that disruptive practitioner behavior policies need to be put in place. Disruptive practitioner behavior policies can go a long way in reining i

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

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

HIPAA Privacy Myths: HIPAA, the most comprehensive and as of now, the only truly Pan-American federal statute on health information, is unfortunately, still a target of misconceptions and myths. In particular, the Privacy Rule, which is the cornerstone of HIPAA's rule on confidentiality of patient information, offers room for many misconceptions. A few common HIPAA Privacy Myths: HIPAA Privacy Myths regarding communication between the patient and physician A common HIPAA Privacy Myth relates to the communication of mails between the patient and the physician. It is a common misconception that since the Privacy Rule is about ensuring the patient's privacy; it disallows email communication between the doctor and the patient. HIPAA Privacy Rule does allow this form of communication, so that the requisite safeguards are built into the communication aimed at ensuring the confidentiality and integrity of the mails. Transmission of the patient's protected health information Another of the common HIPAA Privacy Myths pertains to the transmission of patient information from one healthcare facility to another. Fact is, no permission is required for Covered Entities to disclose patient information from one clinic to another. The Covered Entity can also share Protected Health Information about the patient for legitimate purposes without the patient's consent or knowledge. Cumbersome and expensive HIPAA Privacy Rule regulations Many people tend to believe that the HIPAA Privacy Rule is a tangled web of regulations that are so complex and painstaking in terms of the administrative detail that implementation of the HIPAA Privacy Rule on a national scale is going to burn a hole in the national exchequer. This is completely untrue. On the contrary, over the years, implementation of the HIPAA Privacy Rule has been bringing down the administrative costs quite significantly, resulting in saving of a few billion dollars in the long run on administrative tasks like transactions

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

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

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

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

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 "Internal Auditing for the Medical Device Industry" 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 provides an overview of internal auditing requirements and techniques for medical device companies as a method for risk management and quality improvement. The course will cover auditing requirements, audit planning, preparation, knowledge, auditor skills, interviews, documents and records review, objective evidence, audit report writing and corrective action. Why should you attend: Attendees should attend this seminar for risk management and improvement purposes to identify weaknesses, problems, compliance risks, and improvement opportunities. Who Will Benefit: * Quality Manager * Quality Associate * Quality Engineer * Quality Technician * Regulatory Associate Agenda: Day One Lecture 1: Overview of an auditing program, principles of quality management systems and how they related to auditing, benefits of auditing, and what is auditing. Lecture 2: Types of audits, auditor qualifications, ethics, responsibilities, audit phases, audit planning, and scheduling. Lecture 3: Conducting audits, interview techniques, objective evidence, data collection, tracing, use of checklists, and reviewing documents and records. Lecture 4: Conducting process audits, running closing meetings, audit report writing, corrective actions, and improvement Day Two Lecture 1: Overview to auditing to ISO 13485 and FDA QSR. Global differences which affect auditing approaches, auditing document control and record keeping, management responsibility, and resource management. Lecture 2: Auditing order handling, design control, purchasing, and supplier controls. Lecture 3: Auditing production, validation, and preservation. inspection and testing, control of test equipment, customer property, and sterilization Lecture 4: Auditing customer feedback, internal auditing programs, complaint

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