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

Course "Effective and Efficient Internal and Supplier Quality System Auditing for Medical Devices" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion. Overview: Do you want to understand how to do efficient and effective internal and supplier audits that meet all the requirements of your external auditors, but also add value to your company? Are you confused by all the requirements and guidance documents for medical device quality management systems and are tired of wading through all the regulatory language they contain. This course is for those who will do internal or supplier audits, manage an audit process for these or other company audits. This course will provide you with an easy to understand presentation on the auditing process as well as the requirements you will need to audit under ISO 13485 and the FDA Quality System Regulation (cGMP) Both FDA Quality System Regulation (QSR) and ISO 13485 require that companies do internal audits. However, because the FDA does not look at the content of internal audits, some companies do not get feedback on the true effectiveness of their internal audit system from the FDA during FDA Inspections. ISO 13485 auditors do look at internal audits, but are most concerned that you define a process that meets the requirements of the standard and are following your process. Both require that you define Auditor training is required, but this sometimes just requires reading the company's procedure, although most external auditors will look for more than this. Do you need to train new auditors for yours medical device quality management system or to audit your suppliers? Or do you need to improve the training of your internal and supplier auditors so that they add value to these audits? If you need to do either of these, this seminar will provide this training. In addition to auditing skills and hands-on auditing exercises, this seminar will provide an ove

Dealing with Medicare and Medicaid Overpayments : Medicare and Medicaid overpayments are pretty common. If they are not dealt with properly, they invite penalties. Medicare and Medicaid Overpayments happen when a person, provider or supplier receives a payment that is in excess of the amount due to him or her under Medicare statutes and regulations. This overpayment becomes a federal debt that is owed by the individual to the State. So, Centers for Medicare and Medicaid Services (CMS) is required by federal law to recover this amount. Overpayments routinely occur in Medicare and Medicaid. Many a time, these are unintended and are usually a result of oversight, but could also happen due to intent. Some of the most common reasons for which Medicare and Medicaid overpayments occur can be when: Duplicate submissions of the same service or claim are made Excessive or non-covered services are billed or furnished for billing Services that are not necessary medically or are excluded are paid for The wrong payee gets paid. How are Medicare and Medicaid overpayments processed? Obamacare has amended the federal False Claims Act (FCA), which is part of the Fraud Enforcement Recovery Act of 2009 (FERA), to add provisions relating to recovery of Medicare and Medicaid overpayments. This is how the process of Medicare and Medicaid overpayments works: Whenever Medicare comes to know that any overpayment of $10 (raised to $25 from July 2014) or more is made, it directs the Medicare Administrative Contractor (MAC) to initiate the process of recovery of this overpayment. The MAC starts the process by initially mailing a demand letter in which repayment is requested If no action is taken, a second and third demand letters are mailed in a month following the first one. Contents of a demand mail from Medicare/Medicaid: The demand letter sent by the MAC will explain the details of the Medicare and/or overpayment. When repayment is not made in full within 30 days, interest starts get

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

It is important to ensure food safety in hospitals Hospitals being what they are - where patients of almost all kinds visit or stay - are very potent sources of infection. Infection can arise from any part of the hospital. They can spread from patients to patients, from caregivers to patients, from patients to caregivers, from patients to support or administrative staff and vice versa, and so on. An often overlooked source of infection and contamination is the food that comes into hospitals. Food safety in hospitals is a very important element of hygiene First, an understanding of food safety in the context of hospitals is necessary. Food safety in hospitals is described as the scientific way by which food is prepared, handled and stored in hospital settings. Any food that is prepared in hospital kitchens are, like food prepared in other places such as canteens, hotels and restaurants and even homes, sourced from outside. This food comes from suppliers whose hygiene has to be ensured. Food hazards can come in many forms, including, but not limited to: Biological Chemical Physical Allergenic Hazards an Several other contributing factors It is in the process of procuring materials for food and preparing it in hospital kitchens that a major part of food safety in hospitals is compromised. There has to be a thorough mechanism to ensure that all these producers and suppliers follow regulatory requirements in ensuring that the food they produce and supply to hospitals is clean and safe. Literally thousands of patients get infected from over 250 kinds of bacteria, parasites and viruses when they consume food prepared in hospitals. Findings of a recent study It is pertinent to recall the findings of study done in May 2014 in Geneva, Switzerland. It carried out an examination of chicken supplied to and prepared in a hospital in this city. An astounding four fifths of these chickens were known to have been infected with E.coli, leading to its possible transmission to pati

The body size differences are paralleled by maturational changes. The smaller body of an infant or neonate is substantially different physiologically from that of an adult. Congenital defects, genetic variance, and developmental issues are of greater concern to pediatricians than they often are to adult physicians. A major difference between pediatrics and adult medicine is that children are minors and, in most jurisdictions, cannot make decisions for themselves. The issues of guardianship, privacy, legal responsibility and informed consent must always be considered in every pediatric procedure. In a sense, pediatricians often have to treat the parents and sometimes, the family, rather than just the child. Adolescents are in their own legal class, having rights to their own health care decisions in certain circumstances. In basic terms, pediatricians take care of all of the children's needs from emotional support to medical support. Wheelchair india as Pediatric Wheelchair Manufacturers and Pediatric Wheelchair supplier sale at low cost - price, We Sale online Pediatric Powered Wheelchair and Pediatric Electric Wheelchair at wholesale prices...

Advanced Enzymes is the most prominent manufacturers and suppliers of Phytase Enzymes Animal Nutrition Enzymes. Our Probiotics also called Direct-Feed Microbials Enzymes to work best in pig feed, pig nutrition cattle feed.

We are one of the leading Molnova capsule manufacturer, supplier and exporter in India, offering effective covid medicine for all. Molnupiravir capsule is latest and effective covid treatment medicine, sold under brand name of Molnova. It is available in 200mg and 400mg dosage.

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Nucleic Acid Testing reort presents strategic assessments of current and emerging suppliers of nucleic acid testing products, including their sales, product portfolios, marketing tactics, technological know-how, new products in R&D, collaborative arrangements and business strategies.

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"Microbiology Testing: Granular Analysis of the Global Market" This DataPack contains 800 tables from Venture Planning Group's new 7-country study, "Global Microbiology Testing Market: US, Europe, Japan," including supplier shares, and forecasts for over 100 tests.

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

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

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

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

"Medical Devices Survey 2013-2014: Market Trends, Marketing Spend and Sales Strategies in the Global Medical Devices Industry" is a new report by canadean that analyzes how medical devices industry supplier companies' media spend, marketing and sales strategies and practices, and business planning are set to change in 2013-2014.