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Course "Risk Analysis and Design of Experiments (DOE) in Process Validation and Development" 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 is designed to help scientists and engineers plan and conduct experiments and analyze the data to develop predictive models used to optimize processes and products and solve complex problems. DOE is an extremely efficient method to understand which variables (and interactions) affect key outcomes and allows the development of mathematical models used to optimize process and product performance. The models also provide an understanding of the impact of variability in controllable and uncontrollable factors on important responses. The concepts behind DOE are covered along with some effective types of screening experiments. Case studies will also be presented to illustrate the use of the methods. This highly interactive course will allow participants the opportunity to practice applying DOE techniques with various data sets. The objective is to provide participants with the key tools and knowledge to be able to apply the methods effectively in their process and product development efforts. Why should you attend: · Plan and conduct experiments in an effective and efficient manner · Apply good experimental practices when conducting studies · Determine statistical significance of main and interaction effects · Interpret significant main and interaction effects · Develop predictive models to explain and optimize process/product behavior · Check models for validity · Utilize models for one or more responses to find optimal solutions · Apply very efficient fractional factorial designs in screening experiments · Apply response surface designs for

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

Shingles is a type of skin infection that is mainly caused by the reactivation of herpes zoster or chickenpox virus. Two vaccines till now have proven successful at reducing the chances of developing shingles. One is, Zostavax, which consists of a bigger-than-usual dose of the chickenpox vaccine since shingles and chickenpox are caused by the same virus, the varicella virus. The other vaccine is called Shinglesvax, consists of an adult shingles vaccine which has been proven to be effective in preventing younger children and adults from developing shingles. If someone develops shingles after receiving either of these, they need a varicella immune globulin vaccine. The shingles vaccine is made from a weakened chickenpox virus and when used in combination with symptoms specific to shingles, it greatly reduces the risks of developing the infection. However, there is a possibility of developing more serious side effects such as a rash or muscle pain. Rare side effects include feeling faint, nausea, blurred vision, and chest pain. The factor driving the growth of the shingles vaccine market is the increased prevalence of shingles worldwide. Moreover, the rising geriatric population and the high number of launches and approval of shingle vaccines are also estimated to trigger the market growth. For instance, in August 2019, experts from the Université Laval, Québec, and Centre de research du Centre Hospitalier de l'Université de Québec found that the Shingrix vaccine developed by GSK is very effective in terms of cost and treatment than the Zostavax developed by Merck & Co. The overall effectiveness of the vaccine was 97% and has a higher effectiveness rate among the geriatric population. Shingrix right now is the main competitor of Zostavax in the market. Read more @ https://coherentmarketinsights-blog.blogspot.com/2021/01/the-global-shingles-vaccine-market.html

A Hospital Incident Command System is a wonderfully effective system for handing disasters and emergency situations: A Hospital Incident Command System is an absolute must for hospitals when they have to carry out unforeseen emergencies. Having a process-oriented Hospital Incident Command System is an effective tool for dealing with situations and saving lives. A Hospital Incident Command System (HICS) is a standardized process that helps hospitals deal with emergencies, natural or manmade. HICS is common across hospitals in the US and have common terminology and organizational structure. It is a single system that all hospitals have to use. Since emergencies can happen at any time and can be of any gravity; it is imperative for physicians to have a command of how to deal with emergencies by understanding the Hospital Incident Command System and its role in disaster situations. HICS goes beyond patient care. Physicians and other staff need to both have access to disaster-specific and related information to the Hospital Incident Command System, as well as know how to handle it, in order to bring about an effective response and augment an existing one. Advantage of having a Hospital Incident Command System The biggest advantage of having a Hospital Incident Command System is that its practices and processes are similar to those used by external agencies in times of emergency. This makes sharing incident command systems that much more effective and easier to coordinate, and facilitates information flow. Features of a Hospital Incident Command System A Hospital Incident Command System provides a flexible reporting structure with defined roles and responsibilities It sets up and facilitates communication flow and documentation protocol It provides the hospital operations a concrete strategic direction-oriented support by leveraging and optimizing additional resources such as staff and equipment, so that these are used where they are needed the most. A Hospital Incident

Overview: The connection between the Body, its physiology and particularly biochemistry, have been linked to the mind with particular emphasis upon emotions and stress. This can be easily substantiated in common everyday situations. Anyone who has observed a facial red flush triggered by some sort of embarrassment can attest to the foregoing connection. The emotions and stress play a key role in many if not all diseases and disorders: due to the vastness of the subject, we will focus on the application of the mind/body connection(MBC) to skin. This serves as an introduction to the field of psych dermatology which, although still in its infancy in the USA, is expanding as evidence with regard to the psychological component related to the etiology of skin diseases continues to grow. Concurrently, the field of Alternative techniques IN mind/body treatments continue to grow in leaps and bounds providing effective methods for integration with conventional cosmetic and dermaceutical treatment. This provides a dual complimentary pathway both for prevention and treatment of any/most skin disorders. Expanding on this model, we have already shown how the mind influences the body as per the above example. This general proposition can be extended to include specific skin disorders such as acne rosacea psoriasis eczema and atopic dermatitis to name a few. We will concentrate on Acne for the sake of this discussion. First, focusing on the B component of the BMC model, the primary lesion associated with acne is the formation microcomodones, which are small enough to proceed undetected until larger comodones appear later in the cycle. The latter cycle is initiated by peroxidation of squalene and unsaturated fatty acids present in human sebum. This leads to the foregoing lesions and pro- inflammatory mediators such as cytokines and interleukins followed by an increase of p.acnes on the epithelial cell wall together with increased film formation of the p.acnes is the same area This

Overview: In 2013, The US Department of Health and Human Services made major changes to rules implementing The Health Insurance and Portability Act of 1996 (HIPAA) and Health Information Technology for Economic and Clinical Health Act of 2003 (HITECH). Among the many areas impacted by these rules (billing, marketing, research, IT security, etc.) is fund raising. The amendments significantly modify the methods and practice that hospitals, their institutionally related foundations, and other healthcare charities may or must employ when using ANY patient or client information for fund raising. The webinar will cover how to effectively implement the fund raising regulations in a manner that increases both opportunities for philanthropic support and compliant implementation of the new mandates. The rules include specific operational requirements, some of which prohibit protocols that were required under the original HIPAA regulations. The "magic words" mandated by HIPPA-related regulations changed in multiple areas. The webinar will cover all of these areas to ensure your organization is both legally compliant and operationally effective. The types of information that may be used for fund raising changed significantly. This presents numerous substantial fund raising opportunities, as well as challenges on the use and storage of such information. Among other areas to be presented are The required method for individuals to opt-out of receiving fund raising communication The methods of informing patients and clients of their right to opt-out from receiving fund raising communication The broadly expanded types of fund raising communication subject to opt-out rights How providers, hospital, and related fund raising foundation apply an opt-out election by an individual The type of patient and client information that health charities may use for fund raising The contents of provider's Notice of Privacy Practice How clinicians can assist both their patients/clients and the

Anti-suicide drugs are the most commonly used pharmaceuticals that are prescribed for the treatment of schizophrenia and other mood disorders. The U.S. Food and Drug Administration (FDA) approved these medications in 1970. They are usually called antipsychotic medications. Although they are very helpful in controlling both the mania and depression, this medicine can prove to be very dangerous if taken in high doses even without an anesthetic. These medications are meant for temporary use only, therefore, care should be taken when using it so as not to cause any harmful side effects on the patient's health. Hence, people who have other illnesses should avoid using these medications. Antidepressants such as Clomipramine and Anafranil (Anafranil or Elavil) are some of the most commonly prescribed medications in the treatment for acute and chronic pain. They are effective in relieving the patient's discomfort and can also help him to come up with his life. However, there are reported cases where patients have experienced severe side effects such as confusion, hallucinations, drowsiness, dizziness, agitation, insomnia, and pupil contraction. Some patients may also experience headache, upset stomach, nausea, and diarrhea. Although these medications are very effective, they also have a number of side effects on the patient's health such as irregular heartbeat, blurred vision, and chest pain. Medications such as Carbamazepine, Lamotrigine, and Phenytoin are also known anti-suicide drugs. These medications act in a different way from other types of drugs. They work by altering the protein structures of neurons in the brain. Because of this, the patient's level of consciousness also differs from the patient who takes conventional antidepressant medications. Read more @ https://coherentmarketinsights-cmi.blogspot.com/2021/02/emergence-of-covid-19-increases-cases.html

Drug delivery means different methods, approaches, technologies, formulations, and systems for transporting a pharmaceutical compound in the body to achieve desired therapeutic effects. There are different types of drug delivery including intravenous injectable, inhalation, or absorption. The injectable drug delivery is considered the most effective route of administration for the effective delivery of drugs to the targeted sites. This enhances the patient's compliance with the drug. This method of drug delivery boosts the drug adsorption from various sites including intravenous, subcutaneous, and intramuscular. Moreover, it increases the bioavailability of the drug at the systematic circulation of the drug at the designated site of action. The challenges of administering an injectable drug to an area are unique and complex. It is common practice to inject a small amount of a drug into the skin of a subject in order to administer a larger dose. However, many complications could occur if too much of a drug is injected at once. Since most of these systems are designed to administer large amounts over a long period of time, multiple injections could cause serious health problems, such as infection and damage to vital organs. The future injectable drug delivery will require the development of new methods for delivering medications, and the creation of new products that provide a safer, more effective environment for the delivery process. Read More @ https://coherentmarketinsights-cmi.blogspot.com/2020/11/injectable-drug-delivery-is-getting.html

Ankle Splint Ankle Splint is designed to immobilize, support and stabilize the ankle joint in injury, or offer protection to people prone to ankle injuries. Rigid exoskeleton shell design gives better protection and control of the inversion or aversion of the ankle. Rigid immobilization Foam cushioning One size, that fits all Anatomical Easy to clean. Ankle Splint Features Unique figure of eight gripping Effective control on inversion & eversion movement of ankle Most effective gripping around ankle. Enhances comfort and walking pleasure Large enough room for ankle Unconventional, swollen or distorted ankles can be accommodated No compression hot spots on the ankle , so enhances comfort to injured ankle Reduces chances of sports related injuries in recurrent ankle problems Quick healing and better recovery of the fully immobilized ankle Molded Ethafoam Foam Pad Provides optimal compression and pressure Good cushioning , enhances comfort Skin friendly Ergonomic design Light in weight - enhance compliance Bilateral symmetry - can be used for either ankle Neoprene sleeves - good cushioning ,reduce pressure of gripping straps One size fits all Molded splint with perfect anatomy Pleasing aesthetics Sleek can be used inside the shoe Effective immobilization. Ankle Splint Measurements Measure circumference approx 2 inches above the ankle joint. Size Chart - Size Inches CM Universal 7.2-12 18-30

Tynor Ankle Binder Ankle Binder is an effective device to support, compress and partially immobilize the ankle following ankle sprain to control pain, oedema or inflammation. Composed of two components, elasticized wrap. and compression sleeve, which is knitted on a 3 dimensional computer controlled circular looms. . Dual grip Four way stretchable fabric. Controlled compression. Convenient application. Tynor Ankle Binder Features Anatomically shaped and reduced compression on patella No Chondromalacia on prolonged use Easy knee movement Improved Comfort Elasticized wrap in figure of eight improves ankle stability. Prevents inversion or aversion injuries. Allows controlled compression and pain relief. Bi-layered, cotton on the inside , a dermophillic interphase Enhanced comfort Better sweat absorption No allergies or rash Better patient compliance. Bi-layered, nylon on the outside Ensures long life Excellent aesthetics Color fastness. Retains body heat effectively. Speeds up healing Allays pain Four-way stretchable fabric Effective compression Enhanced comfort. No vaso constriction. Adjusts compression even on uneven diameters. Tynor Ankle Binder Measurements Measure circumference approx 2 inches above the ankle joint. Size Chart - Size Inches CM Small 7.2-8.4 18-21 Medium 8.4-9.6 21-24 Large 9.6-10.8 24-27 XL 10.8-12 27-30

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

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

Tynor Anklet Comfeel Anklet comfeel is a next generation product, to provide mild compression, warmth and support to the ankle joint. It is used to allay pain and inflammation, generally associated with old age, arthritis or injury. Knitted on 3 dimensional computer controlled circular looms, it conforms to the complex anatomy of the ankle with exactness. Closed heel Anatomic shape Four way stretch Uniform compression Simple pull on application. Tynor Anklet Comfeel Features Anatomically shaped and reduced compression on patella Better compression and grip Easy knee movement Perfect conformance to the complex anatomy of the ankle Improved comfort Bi-layered, cotton on the inside , a dermophillic interphase Enhanced comfort Better sweat absorption Better patient compliance. Bilayered, nylon on the outside Ensures long life Excellent aesthetics Color fastness. Four-way stretchable fabric Effective compression Enhanced comfort. Two layered with interwoven air space Retains body heat effectively. Speeds up healing Allays pain

Round Ring Pillow providing effective relief to pressure sores, the rendered round ring pillow is procured from reliable source. In additions to this, the round ring pillow provides effective cushioned seating and effectively enhances the healing process. Round Ring Pillow Specifications Provideds relief to pressure sores. Provides orthopaedic cushioned seating and encourages healing. Construction with soft PVC material. Maximum weight of patient 75kgs. Round Ring Pillow Features Provides even weight bearing Renders stability while seating Easy to use

Patients who are suffering from cancer receive Chemotherapy often suffer treatment side effects including fatigue, sleep disturbances, and other physical and mental side effects. Amongst all, Sleep disturbance is the most common symptoms which are experienced by cancer patients, occurs in approx. 80% of patients during chemotherapy, and results in hindering in quality of life. Several studies have researched the effectiveness of yoga, which includes breathing, postures, and/or meditation, in a population of patients with cancer.

Gastroesophageal Reflux Disease (GERD) is a chronic condition that is characterized by the regurgitation of stomach contents into the throat. GERD is also known as acid reflux disease and it occurs in people of all ages. In milder cases, GERD can be effectively treated with simple pharmacological therapies or by altering a patient's diet. In more severe cases, esophageal surgery might be necessary to remove the troublesome esophageal sphincter and/or improve a patient's general physical condition. GERD can develop when the lower esophageal valve relaxes or becomes weakened. The diagnosis of GERD and gastroesophageal reflux disease can be done by examining the medical history and symptoms. Although acid-reflux disease typically affects the upper body, some of its symptoms can extend down the esophageal tract, making GERD particularly troubling for people who sit or stand for long periods of time. This problem has given rise to a variety of different approaches to treatment, including invasive, surgical treatments, non-surgical treatments and more novel, non-invasive therapeutic approaches. The latest treatment option on the table involves using pharmaceuticals, such as selective serotonin reuptake inhibitors (SSRIs), to help reduce the effects of GERD. There are a number of advantages to this strategy. For starters, SSRIs are believed to have numerous side effects that tend to make them less attractive to certain groups of patients. Electrical stimulation (ESD) is another common form Gastroesophageal Reflux Disease (GERD) Treatment Devices. This technique involves the use of electrodes attached to the esophageal wall to generate a varying amount of electrical current. Antirheumatic drugs, which often cause symptoms similar to those of severe heart disease, are sometimes added to the mixture. A major disadvantage of using plicator devices with ESD is that the procedure can only be performed on an outpatient basis, requiring a patient to remain in the hospital for a fe

Two most common anesthesia techniques used in the United States are intravenous and inhalation. Intravenous anesthetics or commonly known as IVAs are delivered to the lungs by means of the infusion pump, whereas inhalation anesthesia or commonly called inhalation anesthetics are inhaled directly into the nose. The inhalation method is less popular than the intravenous method mainly because of the difficulty in determining the exact drug concentration needed for effective anesthesia. Several studies and clinical trials have focused on determining the efficacy of both types of anesthesia techniques. For instance, in November 2020, a new clinical trial, The Volatile vs Total intravenous Anesthesia for major non-cardiac surgery (VITAL) trial was launched to compare two types of anesthetic to determine how soon after surgery they allow patients to return home. The trail will compare two methods of delivering anesthesia to a patient: inhalation and intravenous. The main functions of inhalation anesthesia are to relieve chest pain, provide relief to the airways in asthma and reduce the amount of sepsis (severe respiratory distress) in critically ill patients. The mechanism of action is quite similar to that of different drugs in the field of medication wherein it effects the different tissues in the body to produce a desired effect. It affects the muscles, ligaments and tissues in the airways by blocking the airway. Inhalation anesthetics are also referred to as antidepressants because it affects the brain chemical systems such as those responsible for depression and anxiety. Read more @ https://coherentmarketinsights-cmi.blogspot.com/2020/12/clinical-trial-focuses-on-determining.html

Overview: The webinar will concentrate on topics that HHS has announced will be the focus of the first round of "desk audits". They reflect significant areas of non-compliance revealed in the 2012 pilot audits and HHS HIPAA violation investigations concluded by Resolution Agreements and Corrective Action Plans. They include: HIPAA Risk Analysis Risk Management based on Risk Analysis Breach Notification Notice of Privacy Practices (for Covered Entities) Minimum Necessary Standard Access of Individuals to their PHI Authorizations Workforce Training This webinar is vital because, in focusing on preparation for a HIPAA Compliance Audit, Covered Entities and Business Associates may review, prioritize and structure their HIPAA Compliance programs. If you have HIPAA Compliance documentation ready to submit on two weeks notice to HHS you are implementing an effective HIPAA Compliance program. In addition, every Covered Entity or Business Associate may face an HHS HIPAA Compliance investigation at any time due to a complaint or a Breach. If you are "audit ready" you will be ready for an investigation - and better able to avoid complaints and prevent breaches. Why should you attend: Every Covered Entity and Business Associate is liable - without prior notice - to be audited for HIPAA Compliance by HHS You will have only 2 weeks after receiving your HIPAA Compliance Audit notification and data request to upload all requested documents to an HHS HIPAA Compliance Audit Portal The HIPAA Compliance Audit data request you receive will specify content and file organization, file names and any other document submission requirements Auditors will not contact an audited entity for clarifications or ask for additional information - it is essential that submitted documents are current, accurately reflect the entity's HIPAA Compliance program and demonstrate HIPAA Compliance Only data submitted on time will be assessed Failure to respond on time may be referred to the HHS regional

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