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

Course "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

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

Ophthalmology is a branch of science that deals with the diagnosis and treatment of ophthalmic (eye) disorders. Optometry equipment are used to monitor, diagnose, and prevent ophthalmic disorders such as glaucoma and cataract. They include a set of equipment used for retina and glaucoma examination, cornea and cataract examination, as well as for general examination. These equipment include wavefront aberrometers, specular microscopes, ophthalmoscopes, autorefractors and keratometers, fundus cameras, visual field analyzers, retinoscopes, and among others. Cataract surgery is one of the most common surgical procedures performed in Germany, where around 700,000 people undergo cataract surgery every year. Cataract surgery is a procedure to replace the lens of the eye with an artificial one. Whereas, glaucoma is one of the leading cause of irreversible blindness worldwide. In Mexico, around 854,000 people have glaucoma in their eyes. Moreover, the phoropter is one of the basic equipment used by optometrists to measure the refractive error and determine the patient's eyeglass numbers. Optometry equipment are designed to prevent potential eye damage, disease, or injuries. Read More @ https://coherentmarketinsights-cmi.blogspot.com/2020/11/simple-guide-to-most-common-optometry.html

OSHA's Standards on Fire Protection in the Workplace : When it comes to Fire Protection in the Workplace; there are several guidelines to be followed. One could go by common sense, but it is not usually sufficient, which is why OSHA has standards relating to Fire Protection in the Workplace. Like it does for all its safety requirements; OSHA requires the employer to take obligatory steps for the protection of employees from fire. These are covered in Title 29 of the Code of Federal Regulations Part 1910 Subparts E and L; and Part 1926 Subparts C and F. Employer obligations are the core of Fire Protection in the Workplace Requiring employers to carry out roles during a fire emergency and training employees towards the same are the foundation of OSHA standards on Fire Protection in the Workplace. Training employees on OSHA's standards on Fire Protection in the Workplace entails training them on all the core areas of handling a fire: The ways of using fire exits The ways of using fire extinguishing equipment The ways by which to organize an emergency exit plan The ways of using fire exits: Fire Protection in the Workplace on fire exits involves having to put in place a well-designed exit route for employees, so that they escape during a fire easily. These should be done keeping in mind the structure of the building. Keeping the exit route free of obstacles is another important requirement of OSHA's standards on Fire Protection in the Workplace. The ways of using fire extinguishing equipment: Having portable fire extinguishing equipment is not mandatory for OSHA, but employees must be properly trained on their use, should an employer have one. These equipment have to be placed at a convenient location for everyone to access easily. The ways by which to organize an emergency exit plan: An emergency exit plan is required as part of Fire Protection in the Workplace for some kinds of employers. It is for those whose activity involves the heavy use of hazardous chemica

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

The dermabrasion procedure, also known as laser skin resurfacing, is a surgical method used to eliminate outermost layers of the skin to enhance the look of smoother skin. Commonly practiced on patients' faces, the dermabrasion procedure can be done in a medical setting by a doctor or other qualified cosmetic surgeon, specifically trained in the technique to do the procedure correctly. During the procedure itself, a combination of local and deep pulsed light (ultraviolet) or green-yellow light is applied to the skin. There is a major difference between traditional and modern beauty dermabrasion Equipment applications. While the former use mechanical equipment, the latter are completely mechanical applications, without the use of any chemicals. There is a need for an effective analysis of this segment so that one may be able to know the best practices for the application of these treatments. Read more @ https://coherentmarketinsights-cmi.blogspot.com/2021/01/beauty-dermabrasion-equipment-is.html

The process of sterilization and disinfection has always been crucial in maintaining optimum hygiene in any given setting. However, the ongoing COVID-19 pandemic has heightened the importance of these processes. Sterilization refers to any process that removes, eradicates, or kills all forms of life particularly, fungi, bacteria, viruses, spores, etc. Sterilization equipment and disinfectants are crucial in modern medical care as patients come in contact with syringes, surgical tools, and bandages all time. These medical devices eliminate any foreign particles, pus, blood, and dirt left behind that could create complications for the next patient requiring surgery. Besides, it decreases bioburden and prevents corrosion of expensive and highly precise tools. There are different sterilization processes performed including steam sterilizing, flash sterilizing, low-temperature sterilizing, hydrogen peroxide gas plasma, ethylene oxide gas sterilization, peracetic acid sterilization, etc. Many regulatory authorities have issued guidelines on how to sterilize medical equipment. The hospitals refer to it as a germ warfare strategy and it is done in a specific order. The first step is cleaning followed by disinfection which involves using liquid chemicals to kill non-spore-forming bacteria. The final step is sterilizing where several methods are employed to kill disease-causing microorganisms and also eradicate transmissible agents such as spores and bacteria. Read more @ https://coherentmarketinsights-cmi.blogspot.com/2020/12/sterilization-equipment-and.html

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.

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Pristine Flex Ostrich Mobility Wheelchair Pristine is the most stylish powered wheelchair with revolutionary Split Frame Chassis (SFC). This indoor outdoor mobility equipment gives great comfort, stability and safety even in the toughest outdoor conditions. The body panels and the shopping basket make this equipment best suited for your kind of lifestyle. Pristine Flex Ostrich Mobility Wheelchair Features Split Frame Chassis (SFC). Call alarm, fault alarm, reverse alarm (on request). Low voltage alarm. Key pad locking. Mobility cut-off while charging. Auto shut-off after 3 minutes. Five speed selector. Length adjustable joystick control unit (can be changed from left to right and vice versa). Foldable, height adjustable and angle adjustable foot rest. Wide arm rest with height and width adjustment. Bucket seat with headrest and lap belt. Seat can be folded for transportation. Seat reclines 25 degrees in 6 steps. Removable and width adjustable calf support. Reflectors as per standards. Head lamp. Tail lamp. Pristine Flex Ostrich Mobility Wheelchair Specifications Load capacity: 110 Kg Speed: 9.5 Kmph max Speed selection: 5 speeds, Speed 1- 1.5Kmph, Speed 2-2.5 Kmph, speed 3- 4.8 Kmph, Speed 4- 7.2 Kmph, Speed 5- 9.5 Kmph Power: 320W Motor speed: 5300 rpm Gear ratio: 32:1 Brake: Electromagnetic Permissible Gradeability: 12 Degrees Drive range: 32-35 Km Ground clearance:2.5 inches Turn circle radius: 620mm Tire: Puncture free foam filled rubber tires Front- Tire diameter: 220X55 mm, Rear- Tire diameter: 320X72mm, Anti tippers-1 inch solid Battery: 24 Volt 48 Ah Sealed Maintenance Free VRLA Charger Input-230/240 Volts AC Single phase, Output-24 Volts-4 Amps DC Overall length with footrest (at 90 degree):1180mm, Overall width:640mm, Overall height: 1250mm, Overall height after folding the seat: 690mm, Overall weight: 102 Kg Seat depth: 500mm, Seat width:480mm, Backrest height: 540mm (without head rest), Backrest width: 440mm, Se

Transport Chair weighs only 14.8 lbs - almost 25% lighter than standard folding transport chairs. The Chair also features breathable nylon upholstery, an attractive colored frame and comfortable, "restaurant-style" arms - so it can pull up to tables and eat comfortably. The chair not only has a fold-down back but is foldable for length-wise for easy transport. The backside of the chair contains a key ring and multiple pockets. Transport chairs make it easier for the loved ones and caregivers to help to get around in comfort and ease. Compared to a standard wheelchair, a transport chair requires a caregiver to push the chair. A transport wheelchair is much lighter than a wheelchair; plus, it is more compact which makes getting around town easier. This chair comes equipped with loop-lock hand brakes that are easy to operate and ideal for locking the rear wheels during transfers. It also has a seatbelt which keeps the passenger securely in place and it is compact when folded making it easy to lift into a car or carry up the stairs. It is equipped with a seat belt, comfortable nylon upholstery, full length permanent armrest, and detachable footrests. It has a 19 inch wide seat that can provide and a weight capacity of 300 pounds. Karma Travel Wheelchair KM TV 20.2: Karma Travel Wheelchair KM TV 20.2 - 606 T-6 aircraft-grade aluminum-alloy frame provides incredible strength. Easy-to-fold in three seconds. Karma Travel Wheelchair KM TV 20.2 Features: Type: Travel Wheelchair T-6 aircraft-grade aluminum Secure brake improve safety Padded flip back armrest PU front caster & rear wheel Karma Travel Wheelchair KM TV 20.2 Measurements: Weight: 8.9kg Seat width: 39.5cm Tyre: PU front casters and rear wheels Capacity: 100kg Folded size: (L/W/H): 610mm x 350mm x710mm. Ultra Lightweight Wheelchair: Its compact design and feather light weight makes it suitable for people on the go. Ultra Lightweight Wheelchair Specifications: Frame Style : Foldabl

Transport wheelchairs or companion chairs are companion wheelchairs where the purpose is for a companion to push the user. Most of transporters have swing-away leg rests, fixed armrests, and side panels. Instead of the usual 'large back - small front' wheels typical of most wheelchairs, light travel chairs have four small wheels providing much easier maneuverability of the chair. Transport chairs make it easier for loved ones and caregivers to help get around in comfort and ease. Compared to a standard wheelchair, a transport chair requires a caregiver to push the chair. A transport chair is much lighter than a wheelchair; plus, it is more compact which makes getting around town easier. This chair comes equipped with loop-lock hand brakes that are easy to operate and ideal for locking the rear wheels during transfers. It also has a seatbelt which keeps the passenger securely in place and it is compact when folded making it easy to lift into a car or carry up the stairs. Weighs just 23.5 lbs and is equipped with a seat belt, comfortable nylon upholstery, full length permanent armrest, and detachable footrests. It has a 19 inch wide seat that can provide and a weight capacity of 300 pounds. Karma KM 2500 L Big Wheel Wheelchair: Karma KM 2500 L Wheelchair Specifications: Width 18" Front/Rear Wheels 6" to 22" 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 11.kg Karma KM 2500 L 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 L Wheelchair Extended Armrest By simulating the natural position of arms, the extended armrest design is ergonomic and creates bigger seating space. An

Transport chairs make it easier for loved ones and caregivers to help get around in comfort and ease. Compared to a standard wheelchair, a transport chair requires a caregiver to push the chair. A transport chair is much lighter than a wheelchair; plus, it is more compact which makes getting around town easier. This chair comes equipped with loop-lock hand brakes that are easy to operate and ideal for locking the rear wheels during transfers. It also has a seatbelt which keeps the passenger securely in place and it is compact when folded making it easy to lift into a car or carry up the stairs. Weighs just 23.5 lbs and is equipped with a seat belt, comfortable nylon upholstery, full length permanent armrest, and detachable footrests. It has a 19 inch wide seat that can provide and a weight capacity of 300 pounds. This wheelchair can be used both indoors and outdoors on forgiving terrain, with a convenient step for the attendant to lift the chair over obstacles. This transport wheelchair gives the freedom to go, with the added convenience of folding up to a manageable size. Karma Travel Wheelchair KM TV 20.2 Karma Travel Wheelchair KM TV 20.2 - 606 T-6 aircraft-grade aluminum-alloy frame provides incredible strength. Easy-to-fold in three seconds. Karma Travel Wheelchair KM TV 20.2 Features Type: Travel Wheelchair T-6 aircraft-grade aluminum Secure brake improve safety Padded flip back armrest PU front caster & rear wheel Karma Travel Wheelchair KM TV 20.2 Measurements Weight: 8.9kg Seat width: 39.5cm Tyre: PU front casters and rear wheels Capacity: 100kg Folded size: (L/W/H): 610mm x 350mm x710mm. Ultra Lightweight Wheelchair Its compact design and feather light weight makes it suitable for people on the go. Ultra Lightweight Wheelchair Specifications Frame Style : Foldable Frame Material : Aluminium (Light weight) Rear wheel to wheel width in open position (inches) : 20" Handle to Handle : 16" Seat Width (inches): 13" Rear Whee

Durable Medical Equipment Billing is somewhat unique if we compare it with other specialty billing. Basically, Durable Medical Equipment (DME) gives therapeutic benefits to patients experiencing certain healing conditions and/or some diseases.

There are a lot of neurovascular therapies which can help in the reduction of your stress levels, improve your overall health and boost your overall health and well-being. This includes spinal decompression, neurovascular vascular technologies and nerve stimulators, vascular therapies and neurovascular imaging. Recent reports from the U.S. National Center for Complementary and Alternative Medicine indicates that neurovascular therapy is being used more frequently than ever before in the past. The number of people opting for this treatment is increasing by two to three times annually. Currently, there is no better way to boost your brain's health and prevent neurological diseases than through neurovascular therapies. Rising need for minimally invasive surgical procedures, higher number of research studies in neurovascular technologies and rising expectation for minimally invasive surgery techniques will provide ample opportunities to the industry growth. In fact, studies suggest that the average cost of neurosurgery has decreased by around 40 percent, which has made it more affordable for more patients to undergo such treatment. Also, the increasing demand for medical devices has resulted in the rise of numerous new medical equipment manufacturers that have been able to offer lower costs as compared to other equipment providers. In the past, non-surgical methods of treatment were primarily limited to treatments using pacemakers or other devices. As the technology became available, the field of neurosurgery expanded and a large number of non-surgical options such as spinal surgery were introduced. Nowadays, spinal surgery is only one of the available neurovascular treatments but is fast catching up. With so many benefits, it is no wonder that the neurosurgeon industry has increased its revenue by more than five times since 1980. Read More @ https://www.blogger.com/blog/post/edit/preview/9197580861156902959/2930096643408701069

An operating room encompasses equipment such as operating tables, operating room lights, surgical booms, and operating room integration systems and surgical imaging displays. Operating room equipment include, operating table, OR lights, anesthesia machine, anesthesia cart, a stainless steel table for sterile instrument, electronic monitor, pulse oximeter machine, automated blood pressure measuring machine, electrocautery machine, a heart-lung machine, and others. Operating tables are very important for the operations of the surgery, as well as for the patient. They are often used for blood tests or other procedures that may require a quick and easy blood draw and can be very useful in this regard. Read More @ https://coherentmarketinsights-cmi.blogspot.com/2020/11/emergence-of-covid-19-has-led-to.html

The Clinical Laboratory Improvement Amendments of 1988 All clinical laboratory testing done on humans in the US, save those done for basic research and clinical trials, have to comply with the provisions of the Clinical Laboratory Improvement Amendments (CLIA). Clinical Laboratory Improvement Amendments, a set of federal amendments carried out in 1988 set out federal standards for carrying out clinical laboratory testing. A clinical laboratory is, according to the CLIA, a facility in which laboratory testing is done on samples procured from humans. This testing is done with the aim of obtaining information with the intention of evaluating health, using which clinicians diagnose, prevent, or treat disease. Having defined a clinical laboratory thus, the Clinical Laboratory Improvement Amendments set out the regulatory guidelines on which clinical trials are to be administered. The fundamental aim of the Clinical Laboratory Improvement Amendments is to ensure accuracy, efficacy, safety, reliability and efficiency of clinical trials. The Clinical Laboratory Improvement Amendments seek to do this by setting aside grades for a range of criteria that relate to these aspects of the clinical trial. These grades are given from a score of 1, meaning the lowest, to 3, the highest, to assess as many as seven criteria of a particular clinical trial. These seven criteria are: Knowledge Materials used in proficiency, quality control, and calibration of materials Features of operational steps Experience and training Troubleshooting of test system troubleshooting and maintenance of equipment Preparation of reagents and other materials Interpreting and judging the results of the tests Points to be borne in mind for enforcing provisions of the Clinical Laboratory Improvement Amendments Provisions set out in the Clinical Laboratory Improvement Amendments are to be enforced through a set of parameters. These include: Procedure manual A basic part of the Clinical Lab

Overview: This webinar will cover everything that you need to know about how to handle HIPAA security incidents, breaches, and complaints and the Department of Health and Human Resources Investigations thereof. Not all security incidents are breaches, but all breaches of confidentiality are within the broad ambit of security incidents. Privacy rule violations, such as failing to give a patient a copy of his or her medical records, may also constitute a breach as the $4.2 million fine assessed against Cignet Healthcare of Prince George's County, Maryland, dramatically proved. Handling an investigation properly is key to determining not only how to handle it to mitigate any harm and to take action to prevent it from happening again but also to determine whether it is reportable to affected individuals and to DHHS. HIPAA requires a complaint procedure (policy). The webinar will suggest what such a document should contain as it also will for the required report procedure (what is reportable, who reports, to whom, and required/suggested contents of the report) and the required response procedure (what do the responsible officials do after receiving the report or the complaint). Investigating a possible security incident is key. The webinar will cover how to conduct a thorough investigation of HIPAA security incidents, breaches, and patient complaints. Finally, the second largest HIPAA civil money penalty or settlement, $4.2 million, was in large part due to the offender's failure to cooperate with the DHHS investigation. The presenter has successfully defended his clients in seven such investigations and knows how to respond to them to avoid or minimize liability. Think of a gap analysis as an examination of: What you currently have in place for HIPAA compliance. Is that adequate? Can it be done better? Is it enough? And what am I missing? Asking these questions will help establish the direction and next steps to take. It lays the ground work for a good Risk Analys