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Roger Steven

Standard Operating Procedures for Clinical Trials - 0 views

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    Standard Operating Procedures for Clinical Trials: A set of standard operating procedures for clinical trials is absolutely vital for ensuring the effectiveness of the study for a number of reasons. Standard operating procedures for clinical trials are a very potent means to help researchers, principals or sponsors ensure the accuracy and consistency of the procedures needed for the clinical trial. What are standard operating procedures for clinical trials? Standard operating procedures for clinical trials are written instructions that are detailed to provide information about every aspect of the trial. With this set of standard operating procedures for clinical trials, principals seek to bring about a level of uniformity in a particular task of the clinical trial. Consistency in these standard operating procedures for clinical trials has to be ensured so that the clinical trial meets local, state and federal government and global guidelines and requirements. Equally importantly, standard operating procedures for clinical trials have to also meet regulatory guidelines set out by bodies such as the FDA. The purpose of standard operating procedures for clinical trials should be to help the trial achieve consistency in the quality control and quality assurance. In addition, standard operating procedures for clinical trials should be designed to help the trial achieve the quality of auditability. This is because any clinical trial goes through audits from regulatory bodies, making the role of standard operating procedures for clinical trials all the more important. Factors to bear in mind while establishing standard operating procedures for clinical trials: Standard operating procedures for clinical trials should thoroughly document these among other elements: Event Reporting Safety Monitoring Laboratory Management Pharmacy Management Development of Protocols Informed Consent Operations at the site of the clinical trial While these may be considered the core asp
Roger Steven

Medical Staff Bylaws Requirements For Joint Commission Accreditation - 0 views

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    Overview: Joint Commission standards set a high bar for hospital medical staff bylaws. Since the 2011 changes to MS 01.01.01, bylaws must meet 37 elements of performance including hearing provisions, credentialing requirements, department director duties and more. But don't stop there-additional requirements are scattered through other Joint Commission standards. Each standard, element of performance and their quirks will be addressed and means of compliance explored. Why should you Attend: Joint Commission accreditation, sought by the overwhelming majority of American hospitals, hinges upon compliance with the Standards and their Elements of Performance set forth in the Joint Commission Accreditation Manual for Hospitals. Some of the most complex, detailed standards involve medical staff bylaws provisions and processes. Federal legal requirements change frequently in ways that unexpectedly affect these Joint Commission standards. This webinar addresses the most up -to-date Joint Commission requirements and industry best practices for medical staff bylaws compliance. Areas Covered in the Session: Joint Commission Standards for Hospitals Medical Staff Bylaws Hospital accreditation requirements Who Will Benefit: Medical Staff President Bylaws Committee Chair Chief Medical Officer Vice President of Medical Affairs Chief of Staff Director of Medical Staff Medical Staff Attorney Hospital Counsel Medical Staff Manager Speaker Profile Elizabeth A. Snelson represents medical staffs across the country, focusing on medical staff bylaws, and works for medical societies on medical staff issues. A frequent speaker on medical staff legal issues, Ms Snelson presents at medical staff leadership retreats, and in programs sponsored by state medical staff services associations and medical societies, the American Medical Association, the American Bar Association, and other organizations. She is Past President of the American Society of Medical Association Counsel, Vice Presi
Roger Steven

OSHA's Standards on Fire Protection in the Workplace - 0 views

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    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
Roger Steven

Quality Management in Healthcare involves putting processes in place and adhering to them - 0 views

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    Quality Management in Healthcare: Quality management in healthcare is a critical requirement for healthcare organizations. Making quality management patient-centric comes first. Adapting and implementing standards and tools is the next step towards this. Quality management in healthcare is of critical importance to the healthcare industry and the patient. Everyone in the loop -from physicians to practitioners to support staff -needs to be aware of the importance of quality management in healthcare. The most basic purpose of imparting high quality management in healthcare is to make sure that the patient is well taken care of. For this to happen, the healthcare setting has to implement systems and processes. Quality management centers on process management. If organizations have to ensure that meaningful quality management in healthcare is being implemented; they have to adhere to processes. Adapting standards and instilling processes into the healthcare system is how healthcare providers can assure quality in healthcare. Patient is at the center of quality management in healthcare Obviously, the first step in the direction of implementing quality management in healthcare is to make the healthcare setting's care and processes patient-oriented and patient-centric. Quality management in healthcare begins with the patient and should be fully tuned to her needs. As patients' requirements and expectations vary over time; quality management has to keep upgrading itself to keep up with the changing needs and demands. In line with this, the following means can go a long way in ensuring quality management in healthcare: The healthcare setting has to identify goals for ensuring quality management in healthcare. Each department has to be given measurable goals to reach. Implementing quality standards goes a long way in ensuring that quality management in healthcare is imparted in the organization. Six Sigma, ISO 9001 and ANOVA are some of the popular standards a
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    Quality Management in Healthcare: Quality management in healthcare is a critical requirement for healthcare organizations. Making quality management patient-centric comes first. Adapting and implementing standards and tools is the next step towards this. Quality management in healthcare is of critical importance to the healthcare industry and the patient. Everyone in the loop -from physicians to practitioners to support staff -needs to be aware of the importance of quality management in healthcare. The most basic purpose of imparting high quality management in healthcare is to make sure that the patient is well taken care of. For this to happen, the healthcare setting has to implement systems and processes. Quality management centers on process management. If organizations have to ensure that meaningful quality management in healthcare is being implemented; they have to adhere to processes. Adapting standards and instilling processes into the healthcare system is how healthcare providers can assure quality in healthcare. Patient is at the center of quality management in healthcare Obviously, the first step in the direction of implementing quality management in healthcare is to make the healthcare setting's care and processes patient-oriented and patient-centric. Quality management in healthcare begins with the patient and should be fully tuned to her needs. As patients' requirements and expectations vary over time; quality management has to keep upgrading itself to keep up with the changing needs and demands. In line with this, the following means can go a long way in ensuring quality management in healthcare: The healthcare setting has to identify goals for ensuring quality management in healthcare. Each department has to be given measurable goals to reach. Implementing quality standards goes a long way in ensuring that quality management in healthcare is imparted in the organization. Six Sigma, ISO 9001 and ANOVA are some of the popular standards a
Roger Steven

Quality Assurance in Nursing is an important discipline in ensuring quality of healthcare - 0 views

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    Quality Assurance in Nursing Healthcare: Quality assurance in nursing is about assuring quality in nursing by ensuring that practices are compliant with quality standards. This is a full-fledged profession with its own educational and experience requirements. Quality assurance in nursing has to be understood from the standpoint of quality assurance and compliance. Quality assurance in nursing is about ensuring adherence to quality standards as mandated by nursing regulatory bodies. Quality assurance in nursing assesses what healthcare processes are in place and what else needs to be implemented to better the system. Where do quality assurance nurses work? Professionals who make a career out of quality assurance in nursing are employed in various healthcare settings. They could work in clinics or small or large hospitals. Professionals who make a career in quality assurance in nursing are licensed registered nurses. Since they are registered nurses, they should also obtain a licentiate. To get this, they should complete a prerequisite approved nursing program. The exam for getting licensure is the National Council Licensure Examination for Registered Nurses (NCLEX-RN), a computer-based examination. A higher level of education for those in quality assurance in nursing is a master's degrees inhealth care quality or a near degree. In some healthcare organizations, this is required at entry level. Some of the works they do in maintaining quality assurance in nursing include: Reviewing reports or files to make sure that activities contained in them are following regulatory clinical standards Collaborating with colleagues from other departments to which nursing is related either directly or indirectly Interacting with other hospitals or organizations, if the need arises For professionals pursuing a career in quality assurance in nursing, the ability to analyze data and manage cases is a must, as a major part of their work involves these. They should also be prompt abou
Roger Steven

Key Factors to Write an Effective Standard Operating Procedure (SOP) and Work I... - 0 views

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    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
wheelchairindia9

Recliner Wheelchair - 0 views

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    A reclining wheelchair allows several key parts of the device, including the foot rests and backrest, to be adjusted to accommodate various needs and positions. Reclining wheelchairs are high back wheelchairs that allow the user to recline from a 90 degree position down to 180 degree position. Reclining wheelchairs have handbrake-like controls that release the back and lock it into place. Reclining wheelchairs are equipped with removable full support headrests, swing away elevating leg rests and padded arm rests for additional support and comfort. Like standard wheelchairs, reclining wheelchairs fold compactly for easy transport and storage. Different Types Of Reclining Wheelchairs: Reclining Wheelchair 902 GC Reclining Wheelchair 609 GC Karma Aurora 4 Reclining Wheelchair Karma Reclining Wheelchair KM 5000 Karma VIP 515 Wheelchair Reclining backrests can be a useful feature for children: Are unable to sit upright for sustained periods because of weak muscles in the upper body, or a stiff spine or hip. Have difficulty breathing. Are receiving treatment that require them to be in a reclined position. Karma Aurora 4 Reclining Wheelchair: Frame Style : Fordable Frame Material : Aluminium (Light weight) Seat Width (inches) : 18" Total width in wheel to wheel : 11" Rear Wheel Size : 24" Front Wheel Size : 7" Seat to floor height (inches) : 20" Seat Depth (inches) : 16" Back height (inches) : 35" Total height (inches) : 50" Max User Weight Capacity (kgs) : 120 Net Weight (kgs) : 13.5 k.g. Upholstery : Cloth water-proof. Armrest : Detachable, for easy transfer to bed. Leg-rest : Detachable, can also be elevated & with calf support for added comfort Wheel Quality : MAG WHEEL Rear Wheel Brakes : Available Hand brakes : Available Reclining Wheelchair Features: Lightweight aluminum wheelchair. Double crossbraces for extra strength. Folding frame. Padded detachable armrests with side panels. Length-adjustable leg supports. Punctu
wheelchairindia9

Jazzy Select Elite - 0 views

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    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"
Roger Steven

untitled - 0 views

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    Quality Management in Healthcare: Quality management in healthcare is a critical requirement for healthcare organizations. Making quality management patient-centric comes first. Adapting and implementing standards and tools is the next step towards this. Quality management in healthcare is of critical importance to the healthcare industry and the patient. Everyone in the loop -from physicians to practitioners to support staff -needs to be aware of the importance of quality management in healthcare. The most basic purpose of imparting high quality management in healthcare is to make sure that the patient is well taken care of. For this to happen, the healthcare setting has to implement systems and processes. Quality management centers on process management. If organizations have to ensure that meaningful quality management in healthcare is being implemented; they have to adhere to processes. Adapting standards and instilling processes into the healthcare system is how healthcare providers can assure quality in healthcare. Patient is at the center of quality management in healthcare: Obviously, the first step in the direction of implementing quality management in healthcare is to make the healthcare setting's care and processes patient-oriented and patient-centric. Quality management in healthcare begins with the patient and should be fully tuned to her needs. As patients' requirements and expectations vary over time; quality management has to keep upgrading itself to keep up with the changing needs and demands. In line with this, the following means can go a long way in ensuring quality management in healthcare: The healthcare setting has to identify goals for ensuring quality management in healthcare. Each department has to be given measurable goals to reach. Implementing quality standards goes a long way in ensuring that quality management in healthcare is imparted in the organization. Six Sigma, ISO 9001 and ANOVA are some of the popular standards and tools t
wheelchairindia9

Ergonomic Wheelchair - 0 views

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    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 (95ยฐ), (100ยฐ) & Angle (105ยฐ) 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 ยผ" Anti-Bacterial cushion AEGIS, removable, mach
Roger Steven

Setting up a compliance program in healthcare - 0 views

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    Setting up a compliance program in healthcare: Organizations that set up a compliance program in healthcare should go by many voluntary regulations from the OIG, apart from those mandated by HIPAA. Setting up a compliance program in healthcare is about being compliant with standards. This entails having to be compliant with several standards, which cover a wide variety of areas. There are several voluntary and mandatory guidelines from the Office of the Inspector General (OIG), apart from standards from HIPAA. Setting up a compliance program in healthcare meeting HIPAA requirements is set out and mandated by the Patient Protection and Affordable Care Act (PPACA). Guidelines from the Office of the Inspector General (OIG) The series of compliance program guidance documents from the OIG are largely voluntary, and are meant for the different sections of the health care industry. These include Hospitals Nursing homes Third-party billers, and Durable medical equipment suppliers. These guidelines are issued with the intention of motivating healthcare units to develop and use their own internal controls aimed at helping them adhere to regulations, program requirements and statutes. The OIG issues documents, which act as guidelines for setting up a compliance program in healthcare by providing principles. These need to be adapted when healthcare organizations have to develop their own compliance program that is in tune with their best interests and needs. Another major aim is served in the implementation of these guidelines for setting up a compliance program in healthcare: They help healthcare units to understand the nature of fraud and other risks associated with abuse, when they are setting up a compliance program for their healthcare unit. HIPAA requirements Setting up a compliance program in healthcare while being compliant with HIPAA regulationsrequires a healthcare organization to put in place measures that ensure that health records must: Be confident
Roger Steven

Seminar on Effective and Efficient Internal and Supplier Quality System Auditing for Me... - 0 views

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    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
wheelchairindia9

Pride Go Chair - 0 views

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    Pride Go Chair The Go-Chair is the first travel chair that combines super portability, maneuverability and style at a low cost. Pride Go Chair Features Easy to remove battery pack and compact, lightweight frame. Twin motors for traction and precision handling. Conveniently disassembles into four manageable pieces. Fits in most vehicle trunks. Top speed of 3.5 mph and enough power to get you where you want to go. Pride Go Chair Specifications Weight Capacity 250 lbs. Turning Radius 26.87" with foot platform Width: 19" Length 27" without foot platform Maximum Speed up to 3.5 mph Ground Clearance: 1.37" Front Wheels 3x5" solid casters Drive Wheels 3x8" solid Rear Wheels 3" solid anti-tips Drivetrain One-motor, rear-wheel drive Braking System Regenerative Suspension Type Limited Standard Electronics: 40A, PG GC3 Battery Size: 12 volt, 12 amp (2 required) Standard Battery Charger: 2A, off-board Per-Charge Range Up to 8 miles Battery Weight 20 lbs. Base Weight 57 LBS. (rear section 34.5 lbs.; front section 22.5 lbs.) Standard Seat Weight 25 lbs. (foldable, compact, lightweight)
sachin_cmi

eClinical Solutions Help Reduce Human Errors and Manage Clinical Data With Real-Time An... - 0 views

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    eClinical solutions are used to improve the clinical development process through data analysis and management. It offers clinical and operational data by providing data management software and customized data management services, including clinical reporting, electronic data capture, data management and standardization, and clinical data repository platform, with total transparency. eClinical solutions allow users to standardize, integrate, manage, and analyze all their clinical and operational data with the help of integrated advanced visualization and analytical capabilities. Moreover, eClinical software help users to comply with budgeting, investigator management, patient management, government regulations, and adverse event reporting system among others. eClinical solutions integrate electronic health records, eTechnologies, electronic consent forms, clinical data management systems, and electronic data capture. Moreover, they are helping researchers in lengthy clinical research processes through proper management. eClinical solutions have gathered substantial market proposition among pharmaceutical and biopharmaceutical companies for streamlining their clinical trials and insights discovery across various phases from I to IV. Read more @ https://coherentmarketinsights-cmi.blogspot.com/2021/01/eclinical-solutions-help-reduce-human.html
Roger Steven

Workplace Safety Regulations - 0 views

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    Workplace Safety Regulations : Workplace safety is a matter of grave importance to any organization. Ensuring the safety of workers is a primary goal of most countries, no matter which kind of political system or setup they have. This is because almost no workplace is free from some or another kind of hazard. These workplaces could be as varied as hospitals, construction sites, engineering plants or agriculture and many more. Governments the world over consider it their duty to provide a safe workplace. Workplace safety can concern any hazard that can happen to either the physical or emotional wellbeing of a worker. National and global workplace safety regulations : Workplace safety regulations are legally stipulated measures that governments require organizations in both the private and public sector to implement in order to ensure safety at the workplace. Almost all countries have their own set of workplace safety regulations. These regulations work in tandem with a few global management systems with the aim of enhancing safety standards at the workplace. A notable global organization that is at the forefront of legislating workplace safety regulations is the International Labor Organization (ILO). These ILO-mandated legislations are meant to supplement the national workplace safety regulations that most countries have. This is done in the belief that many a time, these individual legislations may not be sufficient in themselves. Workplace safety regulations in the US : Like most other countries, the US too has its own set of Occupational Safety and Health (OSH) standards. Owing their origins to the Richard Nixon era in late 1970; workplace safety regulations in the US concretized under what is collectively called the Occupational Safety and Health Administration (OSHA). The major feature of OSHA is that apart from promulgating workplace safety regulations across nearly all conceivable sectors and types of industries; OSHA also has a provision for whistleblow
Roger Steven

Preparing to Comply with the New FDA FSMA Rules Planning Valid Preventive Food Safety C... - 0 views

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    Overview: Upon completing this course participants will leave with a preliminary preventive control implementation plan and will: * Understand US FDA final rules for the Preventive Controls for Human and Animal Foods * Define and review your current system to identify gaps in your preventive controls planning. * Be able to develop and implement a valid preventive control company food safety plan to close any gaps * Write and implement appropriate procedures. * Know your requirements for control over your supply chain * Be able to plan and implement HARPC * Be able to perform environmental monitoring * Know how cross contamination can impact your preventive control plan * Know the difference between validation and verification * Understand and be able to use statistical process controls basics * Be able to plan and implement a team approach to preventive controls * Be able to help your food importers to jump through FDA hoops * Develop a system to risk rank your suppliers * Have a plan in hand that will pass any validation check for preventive controls * Understand some of the technology and costs that can help you establish preventive controls * Prove that your system actually prevents food safety problems * Be able to document and report results to upper management, external food safety auditors and FDA auditors * Save your company money Establish simple, low cost complete data collection and reporting systems. * Establish teambuilding between food safety and quality personnel to develop and implement changes to your current system * Understand food safety, security and recall responsibilities in light of cargo theft, adulteration and temperature failures * Learn how to use your system to get some ROI and improve your marketing position * Review current and future technologies designed to improve and simplify data collection * Establish a completely documented system Why should you attend: Validation of preventive co
Roger Steven

Ethics and Laws for Mental Health Professionals- 2 day In person Seminar - 0 views

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    Overview: Mental health care practitioners work in today's diverse, fast-changing, multidisciplinary health care environment. Nowhere but in mental health is there such diversity of clinicians who provide the same or similar services of counseling and therapy. A potential client has a wide choice of mental health providers from whom to choose. Yet each individual mental health profession has a unique education, training, and experience requirement for practice. While similarities exist, requirements differ from state to state and even from profession to profession with a single state. What are these requirements and how do they apply? The state's authority and power over mental health practitioners often presents challenges to these mental health professionals that are not easy to navigate. Differing sources of legal and ethical authority govern each respective health care practitioner in ways that are similar but not the same. Ethics and law are similar, but not the same. All mental health practitioners must adhere to standards of state law which govern their professional practices, including the very core of the doctor-patient relationship. Codes of ethics and state law may both apply to govern the conduct of this clinician. Even some state laws are referred to as ethical codes. Complaints as to alleged misconduct or ethical failings are received and investigated by a state agency and leave the mental health practitioner with an uncertain process to handle and to defend the state action against them. With this background, this seminar empowers the full understanding and application of ethics and laws for mental health practitioners. Learn to identify and understand an ethical framework for a sound mental health practice. An ethical framework is essential to having the right perspective to examine mental health dilemmas. Compare and contrast regulatory laws and codes of ethics to understand their differing applicability. Know the difference between laws and ethics,
Roger Steven

Applied Statistics, with Emphasis on Risk Management in R and D, QA QC, and Manufacturing - 0 views

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    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
wheelchairindia9

Karma Vip 515 - 0 views

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    Wheelchair with comfortble reclining back headrest. This wheelchair allows the user to obtain a more comfortable position, equally for those who are unable to sit at 90 degrees, but need to lie back. Options include elevating legrests and cushioning. This type of Wheelchair is a superb light weight aluminium total care chair with all the actions one would wish. All fully adjustable, tilt in space, reclining back, multi positional headrest,elevating legrests and full pressure cushioning. The reclining deluxe manual wheelchair. This wheelchair has all the features one would need in a wheelchair, fully adjustable arms, legrests, reclining back and pop off wheels. To remove the wheels simply press the button in the centre of the wheel and slide them off. Ideal for those who need to recline in the wheelchair as the back rest on this wheelchair can be adjusted to any position. With cushions, elevating legrests and other options, this wheelchair can be configured to meet most needs. This chair does not have tilt in space mechanism or pressure care cushioning, for this must look to the tilt in space chair. Comfort and positioning tilt-in-space wheelchair which is durable, modern looking and comfortable. It offers adjustable seat height and depth, back height, length adjustable armpads and infinite recline and tilt. The multifunction tilt in space wheelchair focuses heavily on the need of each individual user which is why it has many adjustments in one frame to make sure it can alter to cater individual requirements. One of the main features of this chair is its tilt in space feature, which allows a step less adjustment of the backrest and the seat angle. This is easily operated from the push handle and can be quickly adjusted when needed. The design of the backrest and seating on the wheelchair helps ensure comfort and support for the user. Wheelchair comes with elevating leg rests fitted as standard which again are step less and easily adjusted. There is also the o
wheelchairindia9

Chair For Cerebral Palsy Child - 0 views

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    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 (
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