Group items tagged

2-day In-person Seminar Applied Statistics, with Emphasis on Risk Management in R&D, QA/QC, and Manufacturing Overview: The 2-day seminar explains how to apply statistics to manage risk in R&D, QA/QC, and Manufacturing, with examples derived mainly from the medical device design/manufacturing industry. The flow of topics over the 2 days is as follows: ISO standards and FDA/MDD regulations regarding the use of statistics. Basic vocabulary and concepts. Statistical Process Control Statistical methods for Design Verification Statistical methods for Product/Process Qualification Metrology: the statistical analysis of measurement uncertainty, and how it is used to establish QC specifications How to craft "statistically valid conclusion statements" (e.g., for reports) Summary, from a risk management perspective Agenda Day One Lecture 1: Regulatory Requirements Lecture 2: Vocabulary and Concepts Lecture 3: Confidence Intervals (attribute and variables data) Lecture 4: Normality Tests and Normality Transformations Lecture 5: Statistical Process Control (with focus on XbarR charts) Lecture 6: Confidence/Reliability calculations for Proportions Lecture 7: Confidence/Reliability calculations for Normally distributed data (K-tables) Lecture 8: Process Capability Indices calculations(Cp, Cpk, Pp, Ppk) Day Two Lecture 1: Confidence/Reliability calculations using Reliability Plotting (e.g., for non-normal data and/or censored studies) Lecture 2: Confidence/Reliability calculations for MTTF and MTBF (this typically applies only to electronic equipment) Lecture 3: Statistical Significance: t-Tests and related "power" estimations Lecture 4: Statistical Significance: ANOVA calculations Lecture 5: Metrology (Gage R&R, Correlation, Linearity, Bias , and Uncertainty Budgets) Lecture 6: QC Sampling Plans (C=0 and Z1.4 attribute AQL plans, and alternatives to such plans) Lecture 7: Statistically valid statements for use in reports Lecture 8: Summary and Impleme

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

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

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

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

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 "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: 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

Course "Fundamentals of Statistical Process Control: Implementation and Assurance of SPC" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion. Overview: This 2-day seminar provides the information you need to use one of the most powerful tools in quality, statistical process control. It will help people in design, quality, and production understand the concepts and effectively implement them. The examples and issues in the seminar come primarily from the medical device industry, but the material is applicable to any production environment. Production process must be controlled to help ensure they are stable. While there are many control methods, the most powerful and often used is statistical process control, SPC. It uses data from the process itself to detect changes - changes that could result from an unstable process. SPC helps determine if a process continues to operate the way it was set up. If not, SPC produces a signal that calls attention to the problem. One very important application is process capability analysis. With a stable process, SPC data can help determine if the process is capable of meeting the product specifications. These are often expressed as process capability indices. Continuous improvement programs can use the information generated by SPC to monitor process variation and identify its causes. These methods can reduce cost, improve product, and enhance customer satisfaction. Why should you attend: Manufacturing companies, especially medical device manufacturers, must control process. Not only is this a regulatory requirement, but is a good business practice. Without a solid understanding of SPC, you put yourself and your company at a disadvantage. On a personal basis, the material in this seminar will help improve your skills; it aligns with the ASQ Body of Knowledge for the Certified Quality Engineer, Green Belt, and Black Belt. These are areas you should master

Overview: Safe hospital care in neither a science nor an art. It is a practice just like the practice by a doctor who combines hindsight of experience and foresight of imagination to come up with an outsight of the best interventions and best protocols. Over time the doctor standardizes the process but is vigilant to any unique requirements of each patient. Such an approach in patient safety is called hazard analysis and mitigation process. This webinar goes a big step farther. It covers innovation strategies to assure that the safety improvements result in a high return on investment and high value to the hospital, and protects the patients. Why should you Attend: About 400,000 patients die each year from hospital mistakes according to a senate hearing. Evidence based methods to reduce adverse, sentinel, and never events are available and successful in aerospace, nuclear, and chemical industries. Why not use them? We need a paradigm shift. We need it in a hurry! You cannot cross the sea merely by standing and staring at the water. Do not be afraid to take a big step if one is indicated. No noble thing can be done without risks Areas Covered in the Session: The Etiologies of Unsafe Care Sufficient Understanding is a Pre-requisite to Safe Care Preventing "Indifferencity" to Enhance Patient Safety Continuous innovation is better than Continuous Improvement Innovations Should Start with Incidence Reports Hazard Analysis Fault Tree Analysis-the Best Tool for Harm Prevention Doing More with Less is Innovation Re-Invent Quality Management Human Errors may be Unpreventable, Preventing Harm is an Innovation Managing Safety: Lessons from Aerospace Protect Patients from Dangers in Medical Devices The Paradigm Pioneers Aequanimitas,The Best Known Strategy for Safe Care Who Will Benefit: Hospital senior management Hospital administrators Doctors Nursing staff Clinical engineers Radiology staff Infection control staff Patient advocates Speaker Profile Dev Raheja

Overview:   Institute for Healthcare Improvement (IHI) defines reliability as "failure-free performance over time2". This is simple enough to be understood by anyone. The aim is to have no failures over an extended time period in spite of variability in the patient environment. spite of variability in the patient environment.  This is in line with the technical definition of reliability as the probability of successful performance of intended functions for a specified length of time under a specified user (patient) environment. In a system where the severity of consequences is high, such as in hospitals, the goal is to achieve reliability as close to 100% as possible. This is called failure-free performance. Some hospitals have achieved this goal for specific medical procedures for several quarters. Can they extend this performance over years instead of quarters? That is the challenge we need to face and find elegant solutions zero mistakes or find a way to protect patients if a mistake cannot be prevented.  Why should you Attend: The failures of the U.S. healthcare system are enormous considering the severity of failures. As much as 400,000 patients die each year from hospital mistakes. Another 2.1 are harmed from nosocomial infections (infections acquired during hospital stay). The cost is in billions. Discussions with doctors show that there is reluctance to apply reliability principles to healthcare systems because the variability in healthcare is enormous compared to the aviation and industrial fields. Each customer (patient) is different and each illness is unique in its own way. Then there are interconnecting systems such as cardiology, gynecology, gastroenterology, emergency medicine, oncology, and patient data from various doctors, pagers, computers, vendor software, and intensive care, each operating independently most of the time. But good approaches to improving the system reliability have been tried and tested in many industries. There is a

Adenovirus diagnostic testing is the most widely used method for determining the presence of adenoviruses in a culture of healthy volunteers and is adapted from the polymerase chain reaction (PCR) method: a procedure by which DNA strands are broken down into smaller pieces, and then are subjected to amplification reactions with adenoviruses. Because adenoviruses do not copy themselves but rather undergo multiple copied copies during viral replication, several different sequences of adenoviruses will be identified by PCRs. If a suitable sequence is detected, it will be amplified and the resulting product isolated. In the case of patients suspected of having adenovirus, the adenovirus diagnostic testing is done by a polymerase chain reaction (PCR) test that can be performed on the patients' blood samples. Adenoviruses that have been identified by PCR will be identified by the confirmation of specific antibodies against the virus. These specific antibodies will react against the viral copies on the strain of adenovirus in the blood samples and will provide an accurate diagnosis. Patients with suspected AD may be asked to undergo EVGI or MBO testing, both of which will confirm the diagnosis. Besides, EVGI will also provide results regarding the presence of a retrovirus in the patients' lymph nodes, and MBO testing will provide conclusive proof that the patients carry the retrovirus. The main factor driving the adenovirus diagnostic testing market is the growth of the treatment monitoring and diagnostic sector. For instance, according to Policynet, in 2018 the global healthcare sector generated a revenue of approximately US$ 1.853 trillion. Additionally, the expansion of the healthcare sectors in the emerging economies is expected to propel the market growth of adenovirus diagnostic testing. Read more @ https://coherentmarketinsights-blog.blogspot.com/2021/03/rapid-growth-on-adenovirus-diagnostic.html

Immunoassays, or DNA assays, are a method of DNA analysis. DNA is the basis of all biological material, including the DNA of living organisms, cells, and tissues. This method can be used to analyze, identify, and profile various biological samples. The analysis of DNA has developed greatly over the years, due to the ability to conduct DNA tests on living people. The use of immunoassays for gene-based analysis has grown tremendously. Primarily, immunoassay analysis is used to evaluate gene-based treatments in oncology, cardiovascular, orthopedics, infectious diseases, and clinical diagnostics. Currently, the primary uses of immunoassays are for the evaluation of gene-based therapies in oncology and cardiovascular clinical trials. The analysis and measurement of immune parameters by immunoassay instruments are known as response curve analysis (RCA). The first analysis of RCA was done by Ward and coworkers in 1980, using monoclonal antibodies to stimulate the lymphocytes Subsequent immunoassay measurement models and systems have been developed to extend the scope of research and to make immunoassay measurement more cost-effective. Read more @ https://coherentmarketinsights-cmi.blogspot.com/2020/12/immunoassay-instrument-is-gaining-rapid.html

The last 2 decades have witnessed an increased use of digital devices due to major advancements in information technology. These advancements have harmed adversely, the most important buddy in our body - The Eye. Devices like desktop and laptop computers, televisions, e-readers, smartphones, tablets, gaming gadgets have impacted our eyes massively which causes digital eye strain. This is a temporary discomfort to eyes that generally follow 2 or more hours of digital device use as people tend to switch between such devices repeatedly or use one for longer periods. Signs of Digital Eye Strain? 1.) Headaches 2.) Eye fatigue 3.) Irritated, dry, or red eyes 4.) Neck, shoulder, and back pain 5.) Blurred vision To know the prevention and treatment methods for Digital eye strain visit the blog

Bone cancer treatments are used all over the world, especially in regions such as the US, UK, and Italy. The standard bone cancer treatment of all types and stages of bone cancer consists of surgery. Surgeons will surgically remove the entire cancerous growth from the bone and surrounding healthy tissue, including lymph nodes. Sometimes, surgeons will only target the lymph nodes. In the bone, surgeons employ limb-sparing methods when possible. Radiation therapy as bone cancer treatment is often used for bone cancer treatment. This kind of treatment is very successful at removing all cancerous cells from the affected area. It uses high-energy radiation beams that are targeted at cancerous growth. Although radiation bone cancer treatment can remove some of the symptoms, it is not a guarantee of complete removal of the disease. This method may give an early diagnosis, but it does not guarantee a successful treatment. However, if this bone cancer treatment is conducted early enough, it will help to slow the spread of the disease. Read more @ https://coherentmarketinsights-cmi.blogspot.com/2021/08/bone-cancer-treatments-are-administered.html

Yes, it is completely fine to opt In-vitro fertilization when suffering from infertility, It is the most popular method accepted all around the globe, and only due to this treatment method many couples have been able to become parents.

The major factor affecting the market include increase in research and development activities to introduce treatment and diagnostic methods to gain higher revenue during the forecast period. This allows the companies to create cost-effective methods and treatment options.Surge in the number of product launches, which meetthe demand posed by the market is anticipated to boost the market in the coming years.Increase in the prevalence of epidermal nevus syndrome associated cases would help the market propel in the next few years. However, lesser medical trained staffs may hamper the growth of the market.