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

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

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

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

Overview: Many infectious diseases were historically confined to specific geographical regions. However, some now pose global threats due to ease of travel, globalization of trade and commerce and global warming. Government Agencies, non-Profit Organizations, Philanthropic groups and others are also funding vaccination programs for regions where infectious diseases are endemic and to deal with new outbreaks.. Such developments are stimulating research in and the development of improved vaccines, their manufacture and control. Supply Chain complexities and stability issues need to be addressed to cope with transport of vaccines to and their use in climatically hostile regions. Programs to address such challenges need to be implemented, being resourced by appropriately trained and qualified staff from a number of disciplines. Development programs for immuno oncology products also require staffing by similarly skilled professionals. Workers currently engaged in Discovery, Development and Manufacture of conventional medications , or those seeking career-change opportunities can develop an understanding of the concepts, constraints and opportunities associated with Vaccine products by attendance at the Webinar. Engineering professionals involved in facility construction, or repurposing can also benefit as can Regulatory Affairs Professionals or staff at medicines Evaluation Agencies. The subject matter is particularly suited to professionals who are expert in the various disciplines associated with conventional medications ("so-called "small molecules") who wish to expand and develop their skills by involvement in vaccine-related programs including immuno-oncology. Areas Covered in the Session: History of and development of vaccine concepts. undamentals of vaccination Vaccine Types Administration of Vaccines Future Concepts Immuno-Oncology Vaccine Manufacture Who Will Benefit: Regulatory Affair Managers Project Management Personnel QA Managers Scientists Technol

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

What is HIPAA ? Compliance with the Health Insurance Portability and Accountability Act (HIPAA) is a core requirement of the stakeholders involved in health information. HIPAA has prescribed standards with which to protect critical data relating to patients. Electronic Health Records (EHRs) are important documents that contain sensitive patient data, and are thus considered Protected Health Information (PHI). Since this data is accessible to a number of players involved in the field of healthcare; it extremely important to set regulatory guidelines aimed at ensuring that patient information remains protected. HIPAA compliance is essentially about staying in compliance with these guidelines. Measures needed to show compliance with HIPAA HIPAA requires a healthcare organization dealing with PHI to implement all of the following measures and comply with them: Physical measures Network measures, and Process security measures The role of HIPAA Privacy Rule and HIPAA Security Rule HIPAA has set out two important rules that pertain to compliance. These are the HIPAA Privacy Rule and the HIPAA Security Rule. While the Privacy Rule relates to how the medical information of a patient is saved, accessed and shared; the Security Rule is about how to implement national security safeguards for protecting electronic PHI, or ePHI. Who all need to be HIPAA compliant? Since the aim of HIPAA compliance is to ensure complete safety of patient data, it has requirements for every stakeholder in the EHR process. These stakeholders comprise: Covered Entities (CE): Anyone involved in the treatment, payment and operations in healthcare Business Associates (BA): Any person who has access to patient information and is involved in supporting treatment, payment or operations. These include third-party administrators and private sector vendors Those with whom BA's work, or those that are called subcontractors Hosting providers. These typically include healthcare software pro

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

Overview: If you've ever felt the frustration of unpredictable results in splint therapy, you're not alone. Join us for this eye-opening course as Dr. Jesek zeroes in on the dentist's role in diagnosis and treatment of TMJ conditions as they relate to occlusion. Why should you Attend: Dr. Jesek is the founder of Jesek Seminars for Success: Promoting and Teaching Excellence in Dentistry (an approved AGD Pace provider.). He has presented at national meetings for the Academy of General Dentistry, the American Equilibration Society, the American Dental Association, the American Academy of Pain Management and Chicago Dental Society Midwinter Meeting. Seminar attendees appreciate his passionate, easy to understand approach and his teaching style, which enables deep learning and provides tools they can use when they get back to the office Monday morning. Areas Covered in the Session: TMJ anatomy and muscles of mastication function. How to use bimanual guidance to determine TM joint health. How to palpate muscles of mastication. Differential diagnosis of TMD and occlusomuscle disorders. Temporomandibular joint rehabilitation. How to know when occlusal treatment will work predictably. How to identify and treat trigger points and muscle pain. How occlusal appliances make restorative dentistry easier. What imaging is needed: panorex, transcranial, tomogram, CT or MRI, and why. How to use emergency appliances to eliminate acute occlusomuscle pain. When you can just equilibrate the teeth and not use an occlusal appliance. How to stop the need of grinding on your crowns at delivery. Who Will Benefit: Dentist and Hygienists Speaker Profile Dr. Warren Jesek graduated from Millikin University with a B.A. in biology and chemistry. After, he completed graduate work studies in anatomy at the University of Nebraska before attending Loyola University Dental School where he received his dental degree in 1979. He has maintained a private general practice in Decatur, Illinois since 1

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: Being in compliance with HIPAA involves not only ensuring you provide the appropriate patient rights and controls on your uses and disclosures of protected health information, but you also have the proper policies and procedures in place. If audited or the subject of a compliance review you will be required to show the government you have all the necessary documentation in place for safeguarding patient Protected Health Information and indicate how you addressed all required security safeguards. This starts with the fundamentals of a HIPAA compliance program. If your healthcare practice or office manager needs to understand what all the HIPAA requirements are or make sure the current program is adequate and can withstand government scrutiny, please join us for this informative and interactive course.  Why should you Attend: The practice or office manager is the backbone of any healthcare office. Besides being responsible for many of the daily operations within an office, the practice manager is often tasked with managing the HIPAA compliance program. Knowing what is required is critically important.  Attendees will leave the course clearly understanding of all the requirements for a comprehensive HIPAA compliance program and to make sure the practice has the proper policies and procedures in place. After completing this course, a practice or office manager will have a clear understanding for what needs to be place when it comes to all of the HIPAA regulations.  Areas Covered in the Session: Why was HIPAA created? Who Must Comply with HIPAA Requirements? What are the HIPAA Security and Privacy Rules? The Role of the HIPAA Security and Privacy Official What is a HIPAA Compliance Program? What is a HIPAA Risk Management Plan? What is meant by "Required" and "Addressable" Implementation Specifications? What are Administrative, Technical, and Physical Safeguards Requirements? What is a HIPAA Risk Assessment? What are HIPAA training requirements?

Most parents tend to worry about what their kids are eating since nutrition is so important to good health. Snacks play a very critical role in everyone's

0 As we all know, health of a nation is the wealth of a nation. Just as technology has transformed our everyday lives, it has played a pivotal role in transforming the diagnosis, treatment and especially management in the healthcare industry.

Many people who have cancer are rather interested in trying anything that can cure them out of this in one piece including complementary and alternative cancer therapies. Alternative cancer treatments can offer some feeling of control over cancer but many alternative cancer treatments are unproven and can be even dangerous. Alternative treatments may not play a direct role in curing cancer but they can help the patients cope up with signs and symptoms such as anxiety, fatigue, nausea, and vomiting and pain difficulty in sleeping and stress may be lessened by alternative cancer treatments.

Since the healthcare industry has taken serious measures to revamp healthcare services, the emphasis on incentive payment programs has increased. MIPS and MACRA, and more offer facilities to physicians that regular payment method can never provide

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

Medical devices play an important role in the delivery of many health care services. Medical supplies refer to any item (basic medical products) that is necessary for treating injury or illness. In the medical parlance, medical supplies generally are understood to mean items that are low cost, disposable, easily available, and in high enough quantity so that the buying department has enough standing orders to ensure the supply of the items when they are in demand. Increasing prevalence of chronic diseases across the globe, especially in North America, is expected to propel the growth of the medical supplies market. According to the Centers for Disease Control and Prevention (CDC), chronic diseases such as diabetes, cancer, and heart disease are the leading causes of death and disability in the United States. Moreover, proactive government initiatives, increasing demand for infection control measures to curb the occurrence of hospital-acquired infections, the rising number of surgical procedures, and increasing demand for medical supplies are expected to augment the growth of the medical supplies market. Read more @ https://coherentmarketinsights-blog.blogspot.com/2021/03/increasing-demand-for-emergency-medical.html

Tonometers, also known as hand-pieces, are mechanical devices that measure eye pressure and the flow of fluid through the cornea, lens and retina. They play an important role in various fields of medicine such as ophthalmology, optometry, clinical measurements, and medical lasers. The most common use of a tonometer is for measuring intraocular pressure or the pressure of the fluid within the eye, which occurs during normal vision. Other uses include in the diagnosis and treatment of certain eye diseases, for obtaining an accurate reading of the pressure of tears during the night, and to prevent or detect possible internal bleeding or infections in the eye. Tonometry is a diagnostic test primarily used to detect glaucoma, one of the leading cause of irreversible blindness worldwide. Increasing incidence or prevalence of chronic eye diseases such as glaucoma is expected to propel the tonometers market growth. For instance, according to the Centers for Disease Control and Prevention, more than 3 million people in the United States have glaucoma. It is the second leading cause of blindness worldwide after cataract. Around 50% of people with glaucoma don't know they have the disease. Read more @ https://coherentmarketinsights-blog.blogspot.com/2021/01/increasing-prevalence-of-chronic-eye.html