Group items tagged

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

Food Safety and Security are two faces of the coin : Food safety and security are two different, but closely related concepts. Although part of the same aspect, they vary in their application and meaning. Both are equally important in ensuring that populations of the world get food that is sufficient and nutritious. Food safety and security are complete without each other. Food safety complements food security, and vice versa. Food safety : Food safety is essentially about the safety of the ingredients that go into food. If food is being sourced from a farm, the food makers have to ensure that the farm has ensured safety standards in producing this food. Food safety is concerned about the amount of chemicals and fertilizers used in production of food. It is also concerned with how much residual pesticide, which could cause harm to humans when the food that is grown using it, is left in the final product, and so on. Food safety is related to and is dependent on factors such as demographics, inputs that go into the cultivation and production of food, availability of water for production of safe food, the use of energy sources in the safe production of food, climate change, etc. Now, food security : Food security, on the other hand, is about more about the food supply chain. When food arrives from the producer to the consumer, it goes through a complex chain that can many times span entire continents. Food may also be sourced and consumed locally. In either case, there is a need to ensure that the points that food travels in and reaches are secure. Ensuring quality throughout : The aim of food security is to ensure that food which travels through many chains and stages should be clean at all these stages. This means that security has to be ensured from rodents and other forms of disturbances at the agricultural fields in which food is produced, then at the granaries in which it is stored, at the routes that it travels, then at the location at which food is pr

Consumption of salt, it states both the positive and negative sides of salt and adds some research reports to add more impact to the writing

Consumption of salt, it states both the positive and negative sides of salt and adds some research reports to add more impact to the writing

The blog is a list of food items that need to be consumed during the monsoons in order to increase one's immunity.

The blog is a list of food items that need to be consumed during the monsoons in order to increase one's immunity.

Do you have anything that is less fattening; you see I'm on a diet. This is a classic statement most of the dieters say. Dieting has become a rage in this era of health consciousness. People unlike before have become very particular about their calorie intake, food they eat and the amount of fat that they consume. Diet is a regulated selection of foods usually done due to medical or cosmetic reasons. Dieting is a form of losing weight by cutting down the fat content in the daily food consumption.

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: The primary goal of this session is to demonstrate why the health care organization needs to perform a risk assessment and how to perform the risk assessment. This includes a description of the types of breaches of protected health information that have already occurred and the reasons those breaches happened. The presentation then provides that reasons that a risk assessment is required in a health care organization and who needs to perform the assessment. There are a number of approaches available both for purchase on the web and performed by professionals on site. This discussion helps the participant determine which approach is best for their health care organization and what portions of the assessment are most important to the organization. The topic addresses the key components of a risk assessment and how to perform the risk assessment. This includes how to define the specific risks, how to know, how to assess the likelihood and impact of the risk and the final determination on the level of severity of the risk for the organization. Finally, the session explains how to interpret the results of the risk assessment, how to use the results of the risk assessment for preparing the health care organization's policies and procedures and how to conduct the HIPAA training for its staff. Why should you attend: In addition to the negative publicity and potential fines, a breach of a patient's health information often leads to litigation which is also time consuming and costly. The way to avoid these situations is to perform a Risk Assessment to understand where the health care organization is risk of an unauthorized breach and provide a basis for becoming HIPAA compliant. There are three reasons why a Risk Assessment is necessary: First, both the HIPAA Privacy and Security Regulations require a Risk Assessment for the organization to be HIPAA compliant Second, as a result of the Risk Assessment the organization knows where it needs to address its effo

It is important to ensure food safety in hospitals Hospitals being what they are - where patients of almost all kinds visit or stay - are very potent sources of infection. Infection can arise from any part of the hospital. They can spread from patients to patients, from caregivers to patients, from patients to caregivers, from patients to support or administrative staff and vice versa, and so on. An often overlooked source of infection and contamination is the food that comes into hospitals. Food safety in hospitals is a very important element of hygiene First, an understanding of food safety in the context of hospitals is necessary. Food safety in hospitals is described as the scientific way by which food is prepared, handled and stored in hospital settings. Any food that is prepared in hospital kitchens are, like food prepared in other places such as canteens, hotels and restaurants and even homes, sourced from outside. This food comes from suppliers whose hygiene has to be ensured. Food hazards can come in many forms, including, but not limited to: Biological Chemical Physical Allergenic Hazards an Several other contributing factors It is in the process of procuring materials for food and preparing it in hospital kitchens that a major part of food safety in hospitals is compromised. There has to be a thorough mechanism to ensure that all these producers and suppliers follow regulatory requirements in ensuring that the food they produce and supply to hospitals is clean and safe. Literally thousands of patients get infected from over 250 kinds of bacteria, parasites and viruses when they consume food prepared in hospitals. Findings of a recent study It is pertinent to recall the findings of study done in May 2014 in Geneva, Switzerland. It carried out an examination of chicken supplied to and prepared in a hospital in this city. An astounding four fifths of these chickens were known to have been infected with E.coli, leading to its possible transmission to pati

A helpful resource for entrepreneurs, freelancers, and any other self employed health insurance consumers.

Many travel wheelchairs are manual wheelchairs. They may have a weight capacity that they can handle which a consumer should research before thinking of purchasing a specific model. There are also lightweight wheelchairs which have a light battery and are powered. These ultra light wheelchairs do not have a full sized battery like most power wheelchairs but are still able to provide assistance without a person having to manually gain momentum. Travel Wheelchair that are motorized are also known to be extremely easy to maneuver in tight situations. They are smaller in size and can usually only hold a person up to maximum weight. Most lightweight wheelchairs are folding wheelchairs or can be broken down into pieces for transport. Although some of the travel wheelchairs that have batteries may be heavier than manual ultra light wheelchairs, they are still light enough in weight to be lifted into the trunk of a car for transport. Since the battery is smaller in size than an average powered wheelchair, travel wheelchairs that are motorized can generally only make it about before the battery needs to be charged. 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

In the healthcare system, the business days, as usual, are over. Around everywhere healthcare system is facing a tough time with rising costs and uneven quality despite the hard work of well-intentioned, well-trained clinicians. Health care leaders and policymakers have tried countless incremental fixes-attacking fraud, reducing errors, enforcing practice guidelines, making patients better "consumers," implementing electronic medical records-but none have had much impact.

What is Depression? Every individual experiences feelings of worthlessness, sadness, and negativity. It is when these feelings spiral out of control and consume the individual to an extent that his/her normal life is disrupted, that depression arises. Depression is a serious medical condition and can significantly weaken the individual both physically and mentally. What are the causes and risk factors of depression? In medical terms, depression is due to a decreased amount of certain chemicals in the brain. Depression has a genetic basis, i.e. depression may run in family. It can also be triggered by an event such as the loss of a loved one, losing a job, etc. There are some hormonal problems like decreased thyroid levels that can also lead to depression. Depression can also follow after the diagnosis of a serious illness and leads to impaired treatment of the disease. It is accompanied by the feeling of not getting well and hence ignoring the medication and the other activities that have been advised by the doctor. Risk factors Traumatic past, abuse, neglect Loss of a loved one Serious medical conditions like Parkinson's disease, etc. Also Read: How to Prevent Depression in Elderly What are the symptoms of depression? Persisting feeling of sadness, anxiety Low self-esteem Feeling worthless Pessimistic mindset Decreased appetite Difficulty in sleeping Oversleeping Inability to concentrate Talking, walking slowly Constantly feeling tired Loss of interest in activities that were previously enjoyable Decreased sexual desire Weight loss Headache Abdominal cramps Having ideas about death, contemplating suicide What are the investigations for depression? As such there are no investigations for depression. If the symptoms listed above continue for more than two weeks, the person is diagnosed with depression. Investigations advised by the doctor can be - Thyroid function tests Cortisol levels in the blood What is the treatment of depression? The treatment is both

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

Phenol formaldehyde resins or phenolic resins are synthetic polymers derived from the reaction between phenol and formaldehyde. Phenolic resins were known as the first commercial resins used in the production of molded products such as billiard balls and laboratory countertops. Phenolic resins are also used as adhesives and coasting. A wide variety of product types of phenolic resin are available in the market, such as formaldehyde-free phenolic resin, bio-phenolic resin, resole resin, cresol, and novolac resin. Furthermore, phenolic resins find major application in several industrial activities (such as wood-adhesive, friction materials, abrasives, fire retardants, hardeners, for insulation purposes, molding compounds, offshore oil drilling, laminates, etc.) owing to its properties such as high mechanical strength, adhesion, heat resistance, moisture resistance, etc. Increasing consumer awareness about the advanced properties of phenolic resin is expected to propel the growth of the market. Moreover, increasing demand for rubber and friction materials from the tire industry, which, in turn, has generated interest in durable and lightweight phenolic compounds, driving the growth of the phenolic resins market. The development of SpaceX Dragon Capsule's heat shield, a phenolic impregnated carbon ablator, is one of the most important technological innovations in the market. This enables the capsule to be reused for future missions, as the raw material allows spacecraft, crew, and cargo to safely return to Earth, despite the high temperatures. Read more @ https://sachinbhombe.blogspot.com/2021/03/asia-pacific-is-expected-to-witness.html

Nutritional supplements are any dietary supplement that is used to treat nutritional deficiencies in the body. Nutritional supplements are intended to provide nutrients that may otherwise not be consumed in sufficient quantities, for instance, amino acids, proteins, minerals, vitamins, or other nutritional ingredients. Products are usually ingested in liquid, tablet, or capsule form. However, at certain times in life, many individuals often need more trace elements, minerals, vitamins, etc. That's when it is a good time to take supplements. The health benefits associated with nutritional supplements are improved cardiovascular health and reduction in signs of aging among others. Increasing prevalence of chronic diseases (such as diabetes, cancer, and heart disease) and the growing geriatric population worldwide is expected to drive the growth of the nutritional supplements market. According to the Centers for Disease Control and Prevention (CDC), chronic diseases are the leading causes of death and disability in the United States. Moreover, growing awareness among people about the benefits of dietary supplements is also expected to propel the market growth. Read more @ https://coherentmarketinsights-blog.blogspot.com/2020/12/growing-awareness-about-benefits-of.html

A lot of claims are made about the positive effects of supplements on vision and eye health, but very few research studies support these claims. Eye health supplements contain vitamins and other nutrients that are beneficial for maintaining eye health and good vision. These supplements are designed to add to nutrients, not replace. Eye health supplements are also consumed to nullify the impact of infections and eye diseases. Cataract affects more than 24.4 million people (age 40 and older) in the United States or about one in every six people in this age range. While, in Italy, there has been a 10% annual increase in cataract surgery procedures. In 2017, around 1,130 individuals out of 100,000 were suffering from cataracts in Italy. Read More @ https://coherentmarketinsights-cmi.blogspot.com/2021/01/eye-health-supplements-help-slow-or.html