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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

Ergonomically designed wheelchair not only for the patients but also for the assistants, both of them are considered users of this wheelchair. WheelCare has been designed to prevent work injury to the assistants by redesigned the handle, seat, hanger, rear pedals and front pedals, make them adjustable and easier to use. Tube-shaped structure allows the users to install extensional gears depends on the different needs. Ergonomic Wheelchairs with a body contouring S-Shaped seat frame and contoured armrests provides the user with all day comfort and ultimate mobility. And since this wheelchair is designed around the human body, less likely to need a seat cushion or other device to help make the wheelchair more comfortable. Ergonomics is really about using bodies safely and efficiently, in a way which doesn't strain the tissues. A way which is comfortable, While working, cooking, driving, creating or other work. Karma Wheelchair KM 7501: Karma Healthcare KM 7501 Pediatric Wheelchair is a manual wheelchair for children. It's ergonomically antelope horn-shaped handle makes it easy to steer and push the chair, and vertical footrest allow legs to be placed in the correct position. One-piece footplate increases stability. The wheelchair has a great look with a bright color and modern style. Karma Healthcare Wheelchair KM 7501 Features: Karma Healthcare Wheelchair KM-7501 Paediatric Wheelchair offers here-we-go handle Caring footrest Seat width: 11" or 13.5" Ultra lightweight and compact Outward extended front wheels 6" solid caster and 14" solid rear wheel Maximum user weight: 60Kg One Year Warranty Karma Wheelchair KM 7501 Measurements: Width 11" 13.5" Front/Rear Wheels 6" to 14" 6" to 14" Seat Width 28cm 34cm Seat Depth 30cm 30cm Overall Width 45cm 51cm Overall Collapsed Width 34cm 34cm Armrest Height 18cm 18cm Overall Length 70W 70W Seat Height 39cm 39cm Backrest Height 36cm 36cm Overall Height 102cm 102cm Weight 9.3kg 9.3kg Karma Ergo

This lightweight portable shower chair commode with casters is packed with features to ensure a pleasant and comfortable bathing experience. One of the greatest benefits is the ultra comfort padded seat featuring an open front design making personal hygiene easy and convenient. When the shower chair is not in use the back and 12 qt. commode bucket can be removed without tools making cleaning and storage simple. The frame is manufactured with lightweight rust resistant anodized aluminum able to withstand a 300 lb. weight capacity. Easy to operate, shower chair. Commode comes equipped with 3" non-skid casters, making transfer to and from any bathroom safe and secure. Commode/shower chair soft seat features strong and practical armrests designed to withstand a lot of load, including the sideways forces that are exerted during sideways transfers.The armrests offer comfortable support for the forearms while sitting and they are long enough to provide sustained support when standing up and sitting down. The armrests can be folded up individually, e.g. to facilitate a sideways transfers. When folded down, the armrest rests behind the backrest thereby preventing fingers, skin or hair from getting caught. Commode Wheelchair Rainbow 6: Karma commode wheelchair rainbow 6 comes with lot of exiting features for elderly or physically challenged person who want commode in wheelchair. Karma Rainbow 6 has single seat with center cut commode having cushion cover on top and removable pan or plastic commode seat with pot. Commode Wheelchair Rainbow 6 Features: Frame Material : M.S.Chrome Plated Single Seat with center cut commode Both Option Available In Single Seat Plastic Commode Seat With Pot. Cushioned Top Cover Square Pan Commode Pan Removable Pan Commode Wheelchair Rainbow 6 Measurements: Frame Style : Foldable Open Position Wheel To Wheel Width In : 26" (Inches) Seat Width : 18" (Inches) Total Width in Closing Position : 11" (Inches) Rear Whe

J6 Power Wheelchair The compact J6 is the ultimate choice for users who demand the superb stability of Mid-Wheel 6 design and tight-quarter maneuverability. Highly adaptable, the J6 accepts a wide range of seating and electronics options while its powerful drive train delivers high-performance torque. J6 Power Wheelchair Features: Mid-Wheel 6 allows six wheels on the ground for maximum stability. Compatible with TRU-Balance Tilt. OMNI-Casters (nylon, spherical-shaped casters) on front and rear prevent wheel hang-ups. Side-mounted, easily accessible freewheel levers. ATX Suspension (Active-Trac with extra stability) incorporates front OMNI-Casters for enhanced. Performance over more varied terrain. Easy front access to batteries. J6 Power Wheelchair Specifications: Drive Wheels: 10" Solid Optional: 10" Pneumatic Caster Wheels Front: 5" Solid Rear: 6" Solid Anti-Tip Wheels N/A Maximum Speed^4/^: Up to 4 mph Ground Clearance: 2.5" (frame) Turning Radius^5/^: 22" Overall Length: 34.74" without foot riggings Base Width: 23.19" Seating Sizes: TRU-Balance® 2 Synergy/Static: W: 10-20" D: 10-20" Power Tilt: W: 14-20" D: 14-20" Lift & Tilt: N/A Seat-to-Floor Heights: TRU-Balance® 2 Synergy/Static8: 16.5" - 17.5" Power Tilt8: 16.875" Lift & Tilt8: N/A Manual Tilt/Recline^10/^: Yes Battery Size^6/^: U-1 Battery Weight^14/^: 23.4 lbs. Available Electronics^12/^: 70A Q-Logic 2 NE 70A Q-Logic 2 NE+ 70A Q-Logic 2 EX Battery Charger 5A Off-board Motor Packages 2-Pole 4 mph Weight Capacity^7/^: 300 lbs.9 Base Weight: 100.2 lbs

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 "HIPAA Security & Privacy Official - Roles and Responsibilities" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion. Overview: Being the HIPAA Security and Privacy Official involves not only ensuring you know the appropriate patient rights and controls on your uses and disclosures of protected health information, but you also have the proper policies and procedures in place. If audited or the subject of a compliance review you will be required to show the government you have all the necessary documentation in place for safeguarding patient Protected Health Information and indicate how you addressed all required security safeguards. This starts with the fundamentals of a HIPAA compliance program. If your HIPAA Security and Privacy Official needs to understand what all the HIPAA requirements are or make sure the current program is adequate and can withstand government scrutiny, please join us for this informative and interactive seminar. Why you should attend: The HIPAA Security and Privacy Official is the backbone of any organization's compliance program. Often times this role is assigned as collateral duty in smaller organizations. Regardless the size of an organization, the HIPAA Security and Privacy Official must know all the requirements for compliance. This is a critical element of the position. Attendees will leave the course clearly understanding the role and all the requirements as the designated as a HIPAA Security and Privacy Official. This seminar will cover reviews, creation, and amending policy and procedure. After completing this course, a HIPAA Security and Privacy Official will have a clear understanding for what needs to be place when it comes to all of the HIPAA regulations. Areas Covered in the Session: Why was HIPAA created? The Role and Responsibilities of the HIPAA Security and Privacy Official Complying with HIPAA Requirements? What are the HIPAA Security

Course "HIPAA for the Compliance Officer" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion. Overview: I will be going into great detail regarding you practice or business and how it relates to the HIPAA Security/Privacy Rule, Areas covered will be history of HIPAA, privacy vs security, business associates, changes for 2016, audit process, paper based PHI, HIPAA and suing, texting, email, encryption, medical messaging, voice data and much, much, more I will uncover myths versus reality as it relates to this very enigmatic law based on over 600 risk assessments performed as well as years of experience in dealing directly with the Office of Civil Rights HIPAA auditors. I will also speak to real life audits conducted by the Federal government (I've been on both sides of these audits) what your highest risks are for being fined (some of the risk factors may surprise you). In addition, this course will cover the highest risk factors for being sued for wrongful disclosures of PHI and the manner in which patients are now using state laws to sue for wrongful disclosures. Don't always believe what you read online about HIPAA, especially as it relates to encryption and IT, there are a lot of groups selling more than is necessarily required. Why you should attend: This lesson will be addressing how practice/business managers (or compliance offers) need to get their HIPAA house in order before the imminent audits occur. It will also address major changes under the Omnibus Rule and any other applicable updates for 2016. There are an enormous amount of issues and risks for covered entities and business associates these days. I will speak on specific experiences from over 17 years of experience in working as an outsourced compliance auditor, expert witness on HIPAA cases, and thoroughly explain how patients are now able to get cash remedies for wrongful disclosures of private health information. More im

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 "Key Factors to Write an Effective Standard Operating Procedure (SOP) and Work Instructions (WIs)" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion. Overview: Writing SOPs or procedural documents can be challenging at times. However, writing SOPs is overall a straightforward process. However, enforcing what you already created and implemented in the pipeline is another story. The term SOP is very obvious. We have seen "clearly written description of how specific tasks are to be done." Another satisfactory definition would be "detailed written instructions that achieve the uniformity of the performance of a specific function." Is the firm doing what the regulations specify? Is the firm doing what their procedures specify? If you are medical device or a pharmaceutical manufacturer, these definitions come as no surprise because when it comes to FDA regulations and guidance documents "establish" means to define, to document (in writing or electronically) and to implement. The goal and emphasis with FDA is simple. Proof of "Establish" is the foundation. Is the firm doing what the regulations specify? Is the firm doing what their procedures specify? Are the procedures being followed and enforced by company personnel? SOPs are needed in regulated industries to give step-by-step instructions for performing a particular job or task. This session will provide a step-by-step overview and a snapshot of the procedure description, the process and format. The subject matter of a SOP may range from how to operate a piece of machinery to how to log into a particular software program. SOPs ensure consistency and reliability because they require training of all affected parties. This session will address recent enforcement actions for SOP related violations but no surprise. Most of our enforcement actions are documentation related, i.e., SOP or other procedural documents. We will review examples from

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

Wheeled platforms with specially-molded seating systems interfaced with them for users with a more complicated posture. A molded seating system involves taking a cast of a person's best achievable seated position and the either carving the shape from memory foam or forming a plastic mesh around it. This seat is then covered, framed, and attached to a wheelbase this becomes more of a custom wheelchair then a standard type. Heavy Duty/High Weight Capacity is a collection of mobility products with expanded maximum weight capacities. Heavy duty wheelchairs, bariatric scooters and more, combined with an expert staff. Heavy duty/high weight capacity wheelchairs feature additional crossbraces for support and heavy duty/high weight capacity electric mobility products have stronger motors to accommodate a higher weight. Heavy Duty manual wheelchairs have a reinforced heavy-duty frame that accommodates weight capacities ranging anywhere from maximum weight depending on the chair. Heavy Duty Wheelchair is strongly constructed and offers a high degree of comfort to larger users. As expect from a wheelchair of this quality, the detachable footrests swing away, the armrests flip back, and the backrest can be folded. The frame is as compact as possible whilst still allowing a wide, comfortable seat (available in 20 or 22" seat sizes), and the extra-wide castors are designed to meet the demands of heavy use. Heavy Duty is a quality option for anyone for a self-propelbariatric wheelchair. Karma 8520 Heavy Duty Wheelchair: It comes with detachable swing away footrests. The wheel chair has flip-back armrests. It comes with centre of gravity adjustment. The wheel chair has wide profile casters. Seat Size 20'' inch & 22'' inch Total Weight 17 K.G. Features : Foldable, lightweight frame for easy portability. Steel double cross-brace frame. Adjustable-tension back upholstery. Armrests are padded, adjustable and removable. Adjustable-length controller mount. Adju

Bariatric Wheelchair is often referred to as a Heavy Duty Wheelchair or Extra Wide Wheelchair with extra weight capacity, reinforced cross braces, and various other design features to ensure that there is reliable durability to handle the extra support. Whether it is additional weight capacity requirements, or simply a wider seat pan or seat width, a wide range of chairs available in the Bariatric category, there are several models and seat widths to choose from in the Reclining Wheelchair or otherwise known as High Back Wheelchair Category. Bariatric Wheelchair is a supportive and comfortable device that provides users with a safe way to experience more independence. The rugged frame made from high-strength aluminum is lightweight yet handles up to maximum weigh so that bariatric patients can have greatly expanded mobility. A wide seat, wider-than-usual casters and tires and double crossbraces provide a reliable and stable foundation that keeps users safe and satisfied. The nylon upholstery is highly breathable, minimizing moisture even during extended periods of use. The Bariatric Wheelchair flip-back, padded armrests and the anti-slip footplates are both adjustable, enabling to get a precisely customized fit. Karma 8520 Heavy Duty Wheelchair: It comes with detachable swing away footrests. The wheel chair has flip-back armrests. It comes with centre of gravity adjustment. The wheel chair has wide profile casters. Seat Size 20'' inch & 22'' inch Total Weight 17 K.G. Commodes are used with a plastic commode pan that must be emptied at regular intervals. The commode pan is removed either by lifting it out from the top or by sliding it out from underneath. These commodes are only designed to transport the user a short distance, e.g across a bathroom, and are not an alternative to a wheelchair. People difficulty standing from chairs, toilets etc then it is important that the commode use has armrests and has a suitable seat height. Ideally, users shou

Travel wheelchair assists people to become more mobile and independent. There are many different types of wheelchairs that are used for various reasons. It is important to understand the limitations and safe operation of whatever wheelchair choose or need. The travel chair seat size (width and depth), seat-to-floor height, footrests/leg rests, front caster outriggers, adjustable backrests, controls, and many other features can be customized on, or added to, many basic models, while some users, often those with specialized needs, may have wheelchairs custom-built. A single-arm drive enables the user to turn either left or right while the two-armed drive enables user to move forward or backward on a straight line. Another type of wheelchair commonly used is a lever-drive wheelchair. This type of chair enables the user to move forward by pumping the lever back and forth. 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. Travel Wheelchairs are usually designed for being as lightweight as is possible for the health of performance or maybe portability. People exactly who travel frequently because of their wheelchairs by means of car or maybe airplane roommates wish a wheelchair is not just lightweight but takes the least number of space doable. Travel information wheelchairs are classified as the most sleek and stylish, lightweight collapsible wheelchairs. The lightest Travel Wheelchair do not need some on the accessories a usual manual wheelchair often have, but a

Thigh Support Applications Mild support to quadriceps and hamstrings. Relieves inflammation and stiffness. Firm compression and therapeutic warmth. Psychological support to geriatric patients. Sports injury, sprains and strains. Post-surgical rehabilitation. Burn care. Thigh Support Features Strong Compression. Four way stretch. Dermophillic. Durable. Breathable and comfortable. Thigh Support Measurements Measure circumference around mid thigh - approximately 6 inches above knee. Size Chart - Size Inches CM Small 14.8 to 17.2 37 to 43 Medium 17.2 to 19.6 43 to 49 Large 19.6 to 22.0 49 to 55

All pediatric wheelchair can be configured with many accessories to meet specific needs. Comfortable, sporty, and reliable.Aesthetically, devices designed for kids are often sleek and colorful, and functionally, they are typically lightweight and adjustable. As any parent knows, young people don't stay the same size for long and since a wheelchair is a major purchase don't want a simple growth spurt to render it useless. That's why kids wheelchair category offers models that feature seat width and depth adjustability, elevating legrests, and other versatile features. 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 Safety belt provided Maintenance free rear solid wheels Cerebral Palsy Wheelchair Recline system: Recline system provides kids with the most comfortable resting environment. It also allows stretching abdominal muscle that reduces the stress and discomfort developed after long sitting on the wheelchair. some characteristics of wheelchair pediatric: Lack of muscle coordination when performing voluntary movements (ataxia). Stiff muscles and exaggerated reflexes (spasticity). Asymmetrical walking gait with one foot or

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

Jazzy Select Elite The Jazzy Select Elite delivers a potent blend of power, performance and style. In-line, front-wheel drive technology gives the Elite excellent stability and maneuverability for solid performance indoors and out. Jazzy Select Elite Features Jazzy includes shroud and controller guards to protect against daily wear and tear. Red or blue color-through shroud. Black high-back seat with removable, replaceable back and seat covers. Dual-layer powder coated frame for increased durability. Larger foot platform. 40 amp, PG GC 3 controller. Built with ease of service in mind. Jazzy Select Elite Specifications Weight Capacity: 300 lbs. Turning Radius: 24.75" Width: 22.75" Length: 34.75" Maximum Speed Up to 4 mph Ground Clearance: 1.5" Front Wheels: 3" solid anti-tips Drive Wheels: 9" solid Rear Wheels: 6" solid casters Drivetrain: Two-motor, in-line, front-wheel drive Braking System Regenerative and electro-mechanical Suspension Type Limited High-Back Seating: 20"W x 20"D (max. dimensions) High-Back Seat-to-Floor Range: 21.5" - 23.5" Specialty Seating: 20"W x 20"D (max. dimensions) Specialty Seat-to-Floor Range: 16.5" - 18.5" Synergy Seating 20"W x 20"D (max. dimensions) Synergy Seat-to-Floor Range 17.25" - 19.25" Standard Electronics: 40A, PG GC3 Battery Size: 12 volt, U-1 (2 required) Standard Battery Charger: 3A, off-board Per-Charge Range Up to 15 miles Battery Weight: 24.5 lbs. each Base Weight: 68.5 lbs. Standard Seat Weight: 43 lbs. (comfort, high-back) Standard Seat Size: 18" x 18"-20"

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

Tynor Ankle Brace Ankle brace is designed to support, stabilize, and limit the range-of-motion of the ankle joint. In injury, or offer protection to people who are prone to ankle injuries. It uses the triple action of straps, laces and rigid lateral natomical splints to provide optimal ankle stabilization. Rigid Splinting Fits left & right. Easy to wear Controlled compression. Comfortable sung fit. Tynor Ankle Brace Features Triple stabilization Splint ensure strong immobilization Lace offers regional tightening, firm grip and good fitting. "Figure of eight Tynor Ankle Brace Measurements Measure circumference approx 2 inches above the ankle joint. Size Chart- Size Inches CM Small 7.2-8.4 18-21 Medium 8.4-9.6 21-24 Large 9.6-10.8 24-27 XL 10.8-12 27-30