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

Tynor R O M Knee Brace Prefabricated, custom adjusted R.O.M. Knee Brace controls and restrict flexion/extension of the knee joint through a multi-point joint fixation system to allow a range of motion or immobilization to the knee. Universal design allows it to be used on quite a big range of population and for a multiple orthopedic problems associated with knee joint. Immobilization at any angle Controlled motion between any two angles Quick and easy application and removal. Tynor R O M Knee Brace Features R.O.M. Dial 0 to 120 degree flexion. 0 to 60 degree hyper extention Locking at any angle or motion between any two angles possible Interval of 10 to15 degrees Pleasurable locking, using easy pull mechanism Neoprene Liner with Silicone Coating Enhanced product grip Less slippage of product High cushioning coefficient and more comfort Less discomfort of tight straps Ergonomic Design Light in weight Bilateral symmetrical Improved patient compliance Easy removal and application Universal design, one size fits all Straps with Reverse Buckle Mechanism Enhanced grip Easy to wear Controlled tightening.

PF Night Splint (Derotation) Applications Prevention and correction of foot drop. Night splint for early healing. Ambulatory, can be used as a day splint. Perfect post-operative immobilisation and derotation. Peroneal / Peritibial nerve or muscle damage. Ankle or Plantar flexion contracture and functional alignment. Can be used to protect the diabetic/ injured ankle & foot. PF Night Splint (Derotation) Features Removable de-rotation bar. Moulded foot casing, aesthetically pleasing and durable. Effective Liner, improved comfort. Highly functional Design, customized degree of dorsiflexion. Double strapping mechanism, better grip.

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

Ergo Wheelchair features an ergonomic "S" shaped seat that provides the perfect shape to fit the human body to relieve pressure, increase stabilization, weight distribution and lower the risk of pressure sores and scoliosis. Ergonomic wheelchair series provides users with a large selection of ultra lightweight wheelchairs that can help improve life. This series has features that include a high strength lightweight frame, foldable and easy to store, breathable anti-bacterial, anti-staining, removable and machine washable cushion. Also includes the exclusive S-Shape Seating System, which provides increased stability, better weight distribution and lowers the risk of pressure sores and spinal injury. Karma S Ergo 115 Wheelchair: This model features our S-Shape Seating System and is our number one best seller for many reasons. At a mere 11.3 kg in weight with detachable foot rest and many features such as removable machine washable and dry-able cushions treated by AEIGIS treated anti-microbial coated seating system. Karma S-Ergo 115 Wheelchair Features: Ergonomic Handrims & S-Shape Ergonomic Seating System Fixed armrest w/ wider concave armpads Swing In & Away Footrests Backrest Pouch attached to the upholstery 24" flat free polyurethane tires, high tread, flat free wheels Seat width: 16"x17" or 18"x17" or 20"x 17" Silver 1/4" Aegis Anti-Bacterial Upholstery, washable Folding backrest / folding seat for easy traveling "Tube-in Center" foot-plate, assures better side leg support High strength, starting weight at only 11.3 kg. (w/o footrests) 7×1" Polyurethane front casters Upholstery: Black breathable mesh bottom & top AEIGIS Frame Color: Pearl Silver or Rose Red Weight Capacity of 115 kg. Karma S-Ergo 115 Wheelchair Measurements: Seat Width 16 inch., 18 inch., 20 inch. Seat Depth 17 inch. Armrest Height 8 inch. Seat Height 19 inch. Back Height 17 inch. Overall Height 36 inch. Overall Open Width 23 inch., 25 inch., 27 inch

Course "Validation and 21 CFR 11 Compliance of Computer Systems: Intermediate to Advanced" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion. Overview: Computer Systems Validation (CSV) also known as Software Validation is all-pervasive in the Life Sciences Industry. It is a requirement of all the predicate rules, as well as 21 CFR 11 and Annex 11. However, unless one knows how to implement CSV, it is often very hard to detect the requirement for CSV, and very hard to determine what needs to be done, to meet domestic and / or international regulations or business continuity requirements. In addition, the FDA has stepped up 21 CFR 11 inspections that include CSV. This course will build on the Validation and 21 CFR 11 Compliance Basic Course, to give hands on experience on executing on the computer systems validation of a system, and to discuss related activities such as Validation Master Plan, Infrastructure Qualification, Project Management for Validation and Validation of Test Tools The attendees must have attended the Basic Validation & 21 CFR 11 Compliance. This is a very hands-on class and the attendees will be expected to use templates provided in the class to create the complete package for the validation of a system The Seminar: This Hands-On course will provide the attendees with more detailed experience on validation / 21 CFR 11 compliance of a computer system, as well as details for activities associated with computer systems validation as follows: 1. Validation Master Plan 2. Complete Validation for a System 3. Excel Spreadsheet Validation 4. Change Control 5. SOPs 6. Test Tools Validation 7. Project Management for Validation Who Should Attend : * VP of IT * Director of IT * Quality Managers * Project Managers (for CSV / IT) * Validation Specialists * Database Administrators * System Administrators * Directors / Senior Directors of Discovery * Directors /

Course "Validation and 21 CFR 11 Compliance of Computer Systems: Intermediate to Advanced" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion. Overview: Computer Systems Validation (CSV) also known as Software Validation is all-pervasive in the Life Sciences Industry. It is a requirement of all the predicate rules, as well as 21 CFR 11 and Annex 11. However, unless one knows how to implement CSV, it is often very hard to detect the requirement for CSV, and very hard to determine what needs to be done, to meet domestic and / or international regulations or business continuity requirements. In addition, the FDA has stepped up 21 CFR 11 inspections that include CSV. This course will build on the Validation and 21 CFR 11 Compliance Basic Course, to give hands on experience on executing on the computer systems validation of a system, and to discuss related activities such as Validation Master Plan, Infrastructure Qualification, Project Management for Validation and Validation of Test Tools The attendees must have attended the Basic Validation & 21 CFR 11 Compliance. This is a very hands-on class and the attendees will be expected to use templates provided in the class to create the complete package for the validation of a system The Seminar: This Hands-On course will provide the attendees with more detailed experience on validation / 21 CFR 11 compliance of a computer system, as well as details for activities associated with computer systems validation as follows: 1. Validation Master Plan 2. Complete Validation for a System 3. Excel Spreadsheet Validation 4. Change Control 5. SOPs 6. Test Tools Validation 7. Project Management for Validation Who Should Attend: * VP of IT * Director of IT * Quality Managers * Project Managers (for CSV / IT) * Validation Specialists * Database Administrators * System Administrators * Directors / Senior Directors of Discovery * Directors / Senior

A Pediatric Wheelchair is a very important piece of mobility equipment for any patient. There are many instances where a patient would find himself in need of one, no just in cases of long-term disability. Upon admittance and discharge from the hospital, a patient is wheeled around. Those with temporary hurts to their lower extremities will also need a Pediatric Wheelchair for a short time. No matter the reasons for needing a Pediatric Wheelchair, many will find themselves looking for the right one for themselves, their patients, or for their medical care facility. For a pediatrician seeking to prescribe a Pediatric Wheelchair, must be sure that the patient has the proper upper body strength to use one. If the patient is too weak for self movement, the practitioner would be better to consider a powered wheelchair for mobility. While Pediatric Wheelchairs are smaller and can be just as manuverable as scooters, that depends upon the patient's own abilities in steering the chair. These are factors that the doctor must think about before recommending what type of wheelchair a patient should get. Cerebral Palsy Wheelchair: Cerebral Palsy Wheelchair Description: The model designed for cerebral palsy child only. Ultra light weight aluminium alloy frame Seat Width 38 cms (15") Net Weight: 18.5 kgs Epoxy powder coated frame Detachable arm rest & foot rest provided Elevated and swinging foot rest Elevated foot rest provided to elevate leg angle Height adjustable and detachable head rest Hydraulic reclining high back for a comfortable posture Hydraulic adjustable seat angle Detachable back and seat pad Extra cushion upholstery provided to under arm, head & calg Foldable Lever and paddle brakes provided Safety belt provided Maintenance free rear solid wheels Cloth look like water proof upholstery Anti wheels for better safety and stability Extra cushion upholstery provided to under arm, head & leg Folding action Lever and paddle brakes provided

Overview: Do you know the steps that going into making new clients aware of your practice? From the first time they become aware of you brand, every step you take and every interaction along the way is more important than you know! Learn how to keep your customers coming back for more and singing your praises to those that matter, as well as a surefire formula to make sure your marketing dollars are working as well as you think they are! (Hint: We'll be GIVING YOU the formula to use from here on out!) Areas Covered in the Session: Each step of the customer acquisition, retention and upsell process Formula to determine the ROI of marketing expenses Who Will Benefit: Medical Practice Owners Managers Marketing Associates Speaker Profile Mara L. Shorr BA, MBM-C, CAC I-VIII is the founder and managing partner of The Best Medical Business Solutions, a Florida-based medical practice consulting firm assisting practices with their operational, administrative and financial health. Jay served as the Vice President of Operations and Practice Administrator for a leading Board Certified Dermatologist and Cosmetic Surgeon in South Florida until her passing in June 2012, and is currently a partner in a leading South Florida plastic surgery center and medspa. A Temple University graduate, Jay has served as a professional motivational speaker for nearly a dozen industry organizations, including the American Academy of Cosmetic Surgery, THE Aesthetic Show, The Aesthetic Academy, The Medical Entrepreneur Symposium, the American Academy of Facial and Reconstructive Plastic Surgery, the American Academy of Anti-Aging Medicine, the American Academy of Cosmetic Surgery, Vegas Cosmetic Surgery and Global Aesthetics, and more! In addition, he is a Certified Medical Business Manager from Florida Atlantic University. He is a Certified Medical Business Manager (CMBM) from Florida Atlantic University and a Certified Aesthetic Consultant (Levels I-VII) from The Aesthetic Practice Associa

Hearing Care Centers of Southern Illinois, we provide a wide variety of products from the top hearing instrument manufacturers, and we can proudly say that we are one of the most trusted hearing care centers in the area. We proudly service our customers while maintaining the highest standards and exceeding expectations at all levels.

Find the fiber content of more than 7,000 foods

Hearing Care Centers » of Southern Illinois, we provide a wide variety of products from the top hearing instrument manufacturers, and we can proudly say that we are one of the most trusted hearing care centers in the area.

Reclining Wheelchairs are specially designed to allow a person to comfortably recline at incremental angles safely and comfortably. Typically used for accommodation of severe hip extension contractures, or thostatic hypotension, and pressure re-distribution for prevention of skin breakdown. Recliner Wheelchairs work better with Elevating Legrests (ELRs); the user's legs and feet can also be re-positioned for maximum comfort and health benefits. The "ELRs" are optional on some models and standard on others. Be sure to ask about which type of ELR is best suitable for seating and position needs. On some wheelchairs this is an option so be sure to check the options and accessories when purchasing. Reclining Back Wheelchair( bed cum wheelchair ) which are suitable for indoor as well as outdoor purposes. These wheel chairs are manufactured using high quality material to ensure high strength and durability. Wheelchairs are available in foldable frames and are capable for maximum weight. Reclining wheelchairs are available in standard folding frames with extended head supports and seat widths up to 24" wide. The recline mechanism is attendant operated with levers much like a bicycle brake lever. The levers operate hydraulic (pump) mechanisms for a smooth adjustment. Using this reclining mechanism, the chair back can easily and frequently be positioned to any angle. Flexible Back Positioning: Reclining chairs offer unlimited back re-positioning for more patient comfort, better blood circulation, and to aid in sleeping. Work best with ELRs: Recliner chairs need Elevating Legrest so the patients legs and feet can also be re-positioned for maximum comfort. On some chairs this is an option so be sure to check the options and accessories section of each product page. Only the Back moves: On recliner wheelchairs the back reclines but the seat bottom stays in-place. Karma Aurora 4 Reclining Wheelchair: Frame Style : Fordable Frame Material : Aluminium (

Cerebral palsy is considered a neurological disorder caused by a non-progressive brain injury or malformation that occurs while the child's brain is under development. Cerebral palsy primarily affects body movement and muscle coordination. Though cerebral palsy can be defined, having cerebral palsy does not define the person that has the condition.Cerebral palsy is a condition that affects thousands of babies and children each year. It is not contagious, which means can't catch it from anyone who has it. The word cerebral means having to do with the brain. The word palsy means a weakness or problem in the way a person moves or positions his or her body. Cerebral palsy is a common complication of very premature birth. The condition is a type of brain injury that causes problems with motor function. It's been a baffling disorder for doctors because of confusion over what causes the brain injury. CP Wheelchair: Ultra light weight aluminum alloy frame Epoxy powder coated frame Detachable arm rest provided Height adjustable and detachable head rest Hydraulic reclining high back for a comfortable posture Detachable back and seat pad Extra cushion upholstery provided to under arm, head. Hand brakes provided Safety belt provided Maintenance free rear solid wheels Cloth look like water proof upholstery Seat Width 14" Net Weight: 19.5 kgs An individual with cerebral palsy will likely show signs of physical impairment. However, the type of movement dysfunction, the location and number of limbs involved, as well as the extent of impairment, will vary from one individual to another. It can affect arms, legs, and even the face; it can affect one limb, several, or all. Cerebral palsy affects muscles and a person's ability to control them. Muscles can contract too much, too little, or all at the same time. Limbs can be stiff and forced into painful, awkward positions. Fluctuating muscle contractions can make limbs tremble, shake, or writhe. Balance, postur

Ergonomic Wheelchair often spend a lot of time leaning on armrests or a table exactly because they are not being supported with good posture in their chairs. This is a matter of seat angle and back angle, adjusting them according to body shape and degree of upper body balance. Poor seating makes slump, trying to get stable. The optimal posture is more upright, allowing spine to support. Ergonomic chairs are designed to confirm to a person's physical dimensions, allowing them to sit naturally and comfortably for long periods of time, while reducing the risk of pressure ulcers. Ergonomic system (Intelligent s-shaped ergonomic seating) provides efficient pressure relief by spreading weight over a greater area, at the same time provides stabilization and reduced sliding. With their lightweight frames and seats designed to reduce or prevent pressure points, ergonomic wheelchairs provide a comfortable option for mobility impaired users who have the upper body strength to propel themselves, or a caregiver strong enough to do so. Karma S Ergo 115 Wheelchair: This model features our S-Shape Seating System and is our number one best seller for many reasons. At a mere 11.3 kg in weight with detachable foot rest and many features such as removable machine washable and dry-able cushions treated by AEIGIS treated anti-microbial coated seating system. Karma S-Ergo 115 Wheelchair Features: Ergonomic Handrims & S-Shape Ergonomic Seating System Fixed armrest w/ wider concave armpads Swing In & Away Footrests Backrest Pouch attached to the upholstery 24" flat free polyurethane tires, high tread, flat free wheels Seat width: 16"x17" or 18"x17" or 20"x 17" Silver 1/4" Aegis Anti-Bacterial Upholstery, washable Folding backrest / folding seat for easy traveling "Tube-in Center" foot-plate, assures better side leg support High strength, starting weight at only 11.3 kg. (w/o footrests) 7×1" Polyurethane front casters Upholstery: Black breathable mesh bottom & t

Pediatric wheelchairs enable child or teen to participate in all types of daily activities. Pediatric wheelchairs are lightweight, portable, and convenient for use at school, day programs, doctor visits, and recreation with family and friends. Pediatric wheelchairs comes in wide range of sizes and vibrant colors for every lightweight wheelchair. A variety of positioning options are also available. Pediatric wheelchairs are manufactured with unsurpassed quality and style, specializing in compact-folding, lightweight wheelchairs for children of all ages - from toddlers to teens! Custom built to child's specific needs, mobility aids offer rehabilitative benefits for physical disabilities from Cerebral Palsy to Autism. Pediatric, or child wheelchairs, are mobile aids designed for and used by children. Children require the use of a wheelchair for many different reasons, some may have suffered head injuries, some have muscular dystrophy or cerebral palsy, some are amputees, and others only have an occasional use of their wheelchairs in lieu of a walking device or crutches. Certain types of pediatric wheelchairs are built to expand in size to accommodate increased bulk and weight by altering a cross balance on the bottom of the chair. The front frames for the legs can be lengthened as child's legs grow longer. For a pediatrician seeking to prescribe a Pediatric Wheelchair, must be sure that the patient has the proper upper body strength to use one. If the patient is too weak for self movement, the practitioner would be better to consider a powered wheelchair for mobility. While Pediatric Wheelchairs are smaller and can be just as manuverable as scooters, that depends upon the patient's own abilities in steering the chair. These are factors that the doctor must think about before recommending what type of wheelchair a patient should get. Pediatric Wheelchair with a body contouring S-Shaped seat frame and contoured armrests provides the user with all day comfort an

Ergonomic wheelchair series provides users with a large selection of ultra lightweight wheelchairs that can help improve life. This series has features that include a high strength lightweight frame, foldable and easy to store, breathable anti-bacterial, anti-staining, removable and machine washable cushion. Also includes the exclusive S-Shape Seating System, which provides increased stability, better weight distribution and lowers the risk of pressure sores and spinal injury. The patented S-Shape Seating System that comes with every wheelchair model in this series provides an ergonomic seating frame that conforms and flexes to the shape of body. Karma S Ergo 106 Wheelchair: The Karma S Ergo Lightweight 106 Wheelchair has a special S-style ergonomic frame and a three position angle adjustable back. It features fixed footrests and a "tube-in center" footplate that assures better side leg support. The backrest easily folds for transportation and storage and it also features a pouch for carrying small items. A 1/4" thick silver colored anti-bacterial cushion is standard, it is odor and stain resistant and is machine washable. Comes standard with an 18" seat width. Karma S Ergo 106 Wheelchair Features: High Strength, weighs only 12 kg. (w/ footrests) Fixed Armrest & Footrest w/anti-tippers Tube-in Center" footplate, assures better side leg support Seat Width: 18"x17" S-Style Ergonomic Seat Fixed armrests w/ Wider Concaved Armpads Anti-Tippers standard on this model 3 easy backrest angle adjustments: "Working" Angle (95°), (100°) & Angle (105°) Aegis Anti-Bacterial Upholstery Rigidifying push-bar, allows stability for user and companion - collapsible with chair 24' Rear polyurethane, high tread, flat free wheels Folding Backrest/ Folding seat for easy travel Extending push to lock manual breaks Pouch for carrying small items attached to upholstery behind backrest Upholstery: Silver ¼" Anti-Bacterial cushion AEGIS, removable, mach