Group items tagged

Molecular diagnosis is a method used to identify a disease at the molecular level, such as proteins, DNA, and RNA, in a tissue or fluid. Various tools are used to detect specific sequences of DNA or RNA that may or may not be associated with the disease such as single nucleotide polymorphism (SNP), deletions, rearrangements, and insertions, which are used for diagnosis and prediction of various infectious diseases, cancer, and other genetic disorders.

Proteomics - Technologies, Markets and Companies"describes and evaluates the proteomic technologies that will play an important role in drug discovery, molecular diagnostics and practice of medicine in the post-genomic era - the first decade of the 21st century. http://www.bharatbook.com/market-research-reports/healthcare-market-research-report/proteomics-technologies-markets-and-companies.html

"Nucleic Acid Testing in Europe: Market Segment Forecasts and Supplier Shares"is designed to help current suppliers and potential market entrants identify and evaluate major business opportunities emerging in the molecular diagnostics market during the next five years.

Overview: Drug and device research is confusing and difficult on its own but when you start combining drugs with devices the regulatory landscape changes as there are more nuances to deal with. Knowing how drug and device studies are each regulated is important in navigating the challenges posed by studies that wish to use both. It is also important to be aware of current guidance affecting the use of both drugs and devices in a study as well current guidance affecting the classification of devices. Why should you attend: Information on drugs and devices is plentiful. But, it can also be daunting .The webinar will give attendees a foundation and a starting point on which they can build. Learning objectives: Define drug research Define device research Explore the differences between the two Describe requirements when drugs and devices are combined in one study Areas Covered in the Session: Defining Drug Research FDA approved drugs Investigational drugs Compassionate use Defining Device Research FDA approved devices 510 K devices Humanitarian Device Exemptions Invitro Diagnostic Devices Investigational Devices Federal regulations governing drugs and devices Guidance governing drugs and devices Combining devices and drugs into one study What are the requirements? What are the regulations and guidance? How these studies are reviewed Who Will Benefit: Investigators Researchers Research Staff Study Coordinators Auditors Research Administrators Speaker Profile Sarah Fowler-Dixon is Education Specialist and instructor with Washington University School of Medicine. She has developed a comprehensive education program for human subject research which has served as a model for other institutions. She crafted budgets, policies, procedures, reporting, and training for the new program. She has initiated the planning, development, authorship and implementation of many human subjects research policies, practices, guidelines, submission and reviewer forms often working with st

Course "Supplier Management for Medical Device Manufacturers" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion. Overview: Supplier selection and management is one of the critical issues for medical device manufacturers. Suppliers provide materials and services to the device manufacturer, which means that they can be critical to performance and delivery of your device. Neither the FDA nor your notified body regulates your suppliers (with a few exceptions). They expect you to have an effective process to ensure your suppliers perform in the regulatory environment. How well do you understand the requirements for supplier management? Could you pass a regulatory audit or inspection without any issues? This course delivers the tools, templates, and methods to help participants implement an effective and efficient supplier management program. This two-day hands-on course provides a clear understanding of the underlying principles of supplier management. The course uses exercises to solidify understanding. In addition, the course uses FDA Warning Letters to illustrate the points and help you learn from others. As part of the practical implementation, the course includes receiving acceptance activities, outsourced processes, process validation at the suppliers' location, supplier auditing techniques, and supplier issues in management review. The course uses the Global Harmonization Task Force (GHTF) framework, but expands it to cover other issues and techniques important in effective implementation. Why should you attend: Since FDA regulations do not allow them to audit your suppliers unless they make finished medical devices, they require that you have sufficient control over them. But from time to time the FDA makes a reinterpretation of what this means. This happened within the last f 5 years, so if you supplier management program is older than that, you need to make major changes in you supp

Course "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

Course "Verification vs. Validation - Product Process Software and QMS" 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 will review the company Master Validation Plan for major key inputs and CGMP deficiencies. It will address the FDA's newer and tougher regulatory stance. This course's aim is to prove "Product Risk Based V&V" by sufficient, targeted and documented risk-based V&V test case elements/scripts. It will teach participants to evaluate its elements against ISO 14971 and ICH Q9 for hazard analysis and product risk management. This course will evaluate different field-tested, U.S. FDA-reviewed V&V protocols; how to employ equipment/process Requirements Specs / DQs, IQs, OQs, and PQs, or their equivalents per ASTM E2500, all against a background of limited company resources. It will review a matrix that simplifies "as-product", in-product", process and equipment, et al, software VT&V, to assure key FDA requirements are not overlooked. While considering the QMS and 21 CFR Part 11; this course will make practical application of these same in two hands-on sessions. Why you should attend: This session helps participants: * Understand Verification and Validation, differences and how they work together; * Discuss recent regulatory expectations; * Know how to document a "risk-based" rationale, and use it in a resource-constrained environment; * Determine key "milestones" and "tasks" in a project; * Locate and document key subject "inputs"; * Compile "generic" Master and Individual Validation Plans; * Learn the key element of a Product V&V File/Protocol; * Understand how to develop Process and/or Production/Test Equipment V&V Files/Protocols; * Get a grasp of basic Test Case construction; * Understand sample sizes and their justification; * Learn the key elements of Software V&V expected by the FDA and how to document; * Deal with hardwa

Course "Internal Auditing for the Medical Device Industry" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion. Overview: This course provides an overview of internal auditing requirements and techniques for medical device companies as a method for risk management and quality improvement. The course will cover auditing requirements, audit planning, preparation, knowledge, auditor skills, interviews, documents and records review, objective evidence, audit report writing and corrective action. Why should you attend: Attendees should attend this seminar for risk management and improvement purposes to identify weaknesses, problems, compliance risks, and improvement opportunities. Who Will Benefit: * Quality Manager * Quality Associate * Quality Engineer * Quality Technician * Regulatory Associate Agenda: Day One Lecture 1: Overview of an auditing program, principles of quality management systems and how they related to auditing, benefits of auditing, and what is auditing. Lecture 2: Types of audits, auditor qualifications, ethics, responsibilities, audit phases, audit planning, and scheduling. Lecture 3: Conducting audits, interview techniques, objective evidence, data collection, tracing, use of checklists, and reviewing documents and records. Lecture 4: Conducting process audits, running closing meetings, audit report writing, corrective actions, and improvement Day Two Lecture 1: Overview to auditing to ISO 13485 and FDA QSR. Global differences which affect auditing approaches, auditing document control and record keeping, management responsibility, and resource management. Lecture 2: Auditing order handling, design control, purchasing, and supplier controls. Lecture 3: Auditing production, validation, and preservation. inspection and testing, control of test equipment, customer property, and sterilization Lecture 4: Auditing customer feedback, internal auditing programs, complaint

In just a few months the new ICD-10 diagnostic codes will officially take effect and physicians will be required to be 100% compliant or risk not getting

Overview:   Review 6 points of high quality evidence based clinical documentation Review of 7 criteria that all entries in a patient record should include Impact of documentation on coding and claims Impact on audits and ability to defend an audit When an audit is initiated, the completeness of documentation becomes critical in the ability to support what you have reported. Let's take a look at areas in which weaknesses are often found.  Why should you Attend:  The granularity and accuracy of the ICD-10 code set is supported by quality clinical documentation. It is anticipated that payers will increasingly become less flexible in allowing non-specific codes. The use of unspecified codes will likely lead to rejected claims if it is possible to report the more definitive condition. In most cases, unspecified should not be reported unless there is clear evidence to support the inability to report the detailed option.  Is your E & M level supported in the documentation? If you have never experienced scrutiny of your billing patterns by payers and other entities, you may not be aware of weaknesses that lead to recovery of funds or other costly consequences. Your documentation will be key in supporting diagnoses, service codes and acuity of the patient. It is not just payers who engage in audits. Others include State medical boards, Qui Tam and possible reporting of questionable practices by patients. Do your billing patterns and documentation stand up under reporting scrutiny? This presentation will review areas in which you may not be as strong as you think!  Areas Covered in the Session: Significance of abnormal lab results Measurement of lesions, when taken and inclusion of margins Start & stop times & methodology for infusions & discrepancies in billing Diagnostic testing and medications should be supported in a diagnosis Depth of wounds and cause should be clear Severity of illness Diagnosis present on admission? Who Will Benefit: Coders Billers Rev

Lifeline Laboratory is best path lab in Delhi NCR with NABL accreditation. We provide home collection service in Delhi NCR with accurate report within a day

If you are looking for health checkup done visit thier website and book youre test online

If you are looking for health checkup done visit thier website and book youre test online

The term medical devices cover a wide range of medical equipment from common tongue depressors to highly sophisticated surgical and advanced diagnostic equipment that are used in various specialized medical disciplines. These different types of equipment are extensively used in various sized hospitals ranging from rural health clinics to multi-specialty hospitals providing tertiary patient care. Similar to medicines and medical technologies, the medical devices are also highly essential for maintaining proper patient care.

Liquid biopsy, a minimally invasive cancer diagnostic tool, has gained momentum in the last five years due to its advantages over the archaic painful procedure of solid tumour biopsy.

Laboratory centrifuge equipment is used to separate materials from the liquid medium into which they dissolve, depending on their shape, size, density, and viscosity. It works on the principle of centrifugation. A centrifuge is a device that uses centrifugal force to separate various components of a fluid. It is also used to separate cellular elements such as red blood cell (RBC) and white blood cell (WBC) from a blood sample, remove protein precipitate from analytical sample, separate solid or semisolid precipitant from the analytical sample, and isolate macromolecules such as RNA, DNA, and lipids from the cell. Laboratory centrifuge equipment is widely used to conduct a diversity of laboratory work, and thus, there is a growing demand for reliable, durable, and multifunctional laboratory centrifuge equipment. With increasing diagnostics and research and development activities, the demand for such equipment is also increasing. According to the World Health Organization (WHO), in 2018, noncommunicable diseases (chronic diseases), such as diabetes, cancer, and heart disease, kill around 41 million people each year, equivalent to 71% of all deaths worldwide. Non-transmissible chronic disease is the most pressing health problem in Mexico in recent decades. Read more @ https://coherentmarketinsights-cmi.blogspot.com/2021/03/laboratory-centrifuge-equipment-used-to.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