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Medical Device Complaints and Corrective and Preventative Action (CAPA)
Complaint handling and Corrective and Preventative Action (CAPA) is considered by the FDA to be two of the most important areas to assure medical device safety and efficacy. They are in the top five areas where FDA finds problems during inspections and issues 483’s. Medical device developers must understand the complicated Complaint and CAPA process and have a strong CAPA program. A key understanding is str..
Medical Device Recall Management
Despite best efforts, serious quality issues resulting in the recall can occur. Medical Device companies need to be prepared in advance to handle a difficult situation. This webinar will prepare you to understand the signals that trigger a need to recall, the investigation and other actions required, taking corrective and preventive action, and notifications to customers and regulatory bodies.This webinar w..
Medical Device Regulations in the Middle East and North Africa Region
This seminar will provide an essential overview of the key areas of requirements for product approvals for medical devices in the Middle East and North Africa. The programme will cover the regulatory requirements and developments in the individual countries such as Algeria, Bahrain, Egypt, Iran, Iraq, Jordan, Kuwait, Lebanon, Libya, Morocco, Oman, Palestine, Saudi Arabia, Sudan, Syria, Tunisia, UAE, and Yem..
Medical Device Risk Management Following ISO 14971:2019
The US FDA expects that as part of a product development Design Control Program risk management will be conducted. FDA also expects that a post-production risk management program is implemented. FDA recommends using ISO 14971 as a guide and has accepted it as a recognized standard. Hazard Analysis is described in ISO 14971. This is the most powerful of the risk management techniques because it considers ris..
Medical Device Software 62304 Compliance
The webinar will leave you with the information needed to create and maintain good documentation that meets FDA compliance standards. You will learn about what must be done and what must not be done. In addition, you’ll learn about the various computer system validation deliverables and how to document them. This session will provide insight into the IEC 62304 standard as it is applied to medical device sof..
Medical Device Software Validation that Meets FDA Requirements
This course will teach how to conduct a software validation program for medical devices containing software that will satisfy FDA requirements and produce a safe product. We will explain the role of risk analysis invalidation. How software requirements are developed and used in validation will be described.Learning ObjectivesSoftware validation is more than testingRequirements traceabilityRisk analysisUnit,..
Medical Staff, Telemedicine and Other Changes: Meeting CMS Conditions of Participation and TJC Standards
The Centers for Medicare and Medicaid Services (CMS) hospital CoPs has a section on the medical staff. It includes information on credentialing and privileging requirements, implementing Medical Staff (MS) bylaws and rules and regulations, hospitals in systems. This webinar will also cover the Joint Commission standard for medical staff, plus telemedicine and the federal regulations under CMS associated wit..
Meeting Facilitation Skills For Managers
Most people consider meetings the bane of their existence – pulling them away from meaningful work. They make sure they have their phone to check email, texts, Facebook, Instagram, LinkedIn or even shipping dates on Amazon.This webinar helps you facilitate meetings that matter. With this instruction, you will avoid meetings can are considered a total waste of time. Your meetings will have a clear purpose no..
Meeting Management: Stop Wasting Time; Start Getting Work Done and Even Have Some Fun
Ask managers what part of their job they find most taxing and tedious and the answer is sure to come in a loud and unanimous voice – Meetings. Too many, too often with too few results. Nothing seemed to get accomplished; the agenda was unclear; people were late…or didn’t even show up. Let’s face it. Meetings have a bad reputation; they are time wasters. The best you can hope for is to get through them. Righ..
Mental Illness Awareness Skills for Your Workplace
1,000,000 people in the U.S. miss work each day, due to stress. That converts to over 300 Million lost workdays per year. Can your company afford to be part of this equation? I don’t think so. Depression alone results in more days of disability than heart disease, hypertension, and diabetes. The cost alone to treat mood disorders is around $50 BILLION. Depression that is untreated, undiagnosed, or ineffecti..
Mexico Import Process Basics
Non-tariff measures (barriers) are generally defined as policy measures other than ordinary customs tariffs that can potentially have an economic effect on international trade in goods, changing quantities traded, or prices or both (UNCTAD).Areas Covered Non-Tariff Barriers definition and objectiveDifference between a Direct and an Indirect NTBDirect NTB’s established by the Mexican ..
Microaggressions: Harmful speech or free speech?
Everyone is working hard to create cohesive work teams and if you have ever been tasked with ensuring the success of a project or left wondering why your team just couldn’t seem to work together, you know that when people have to work together, challenges can occur.We’ve all done it... we’ve inadvertently hurt someone’s feelings or insulted them without thinking. But is that really a microaggression? Microa..
Microsoft Excel For HR Professionals: 9 Essential Functions You Must know
Recruitment, training & development, compensation & benefits, payroll, employee relations, staff retention, etc. HR professionals are often seemed to have the easiest jobs in the company.Or is it?In reality, what goes behind the scenes is the endless amount of human resource information system (H.R.I.S.) inputs, preparing reports for the management, and spending face-time with employees just to get ..
Microsoft Excel: Data Management Features (Sorting, Filtering, Tables, Subtotals…)
Microsoft says that up to 70% of users surveyed use Excel to maintain a database or large lists. To be truly proficient in Excel, you must be familiar with these tools to manage data efficiently. It’s all the more important as data collection has become more automated and you’re getting swamped with tons of data. But what can you do with all that data? You need to know how to re-arrange the data (sort), see..
Modeling and Optimizing Process/Product Behavior using Design of Experiments
Experimentation is frequently performed using trial and error approaches which are extremely inefficient and rarely lead to optimal solutions. Furthermore, when it’s desired to understand the effect of multiple variables on an outcome (response), “one-factor-at-a-time” trials are often performed. Not only is this approach inefficient, but it also inhibits the ability to understand and model how multip..