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Courses

  • 61 Request Info

    The 21 Elements of a 510(k)

    This webinar will provide valuable guidance to regulated companies in development and implementation of formal, defined, documented methods for analysis of product requirements and documentation necessary to file a 510(k). The 510(k), in any of its three allowable formats, with up to 21 required elements. A brief discussion of how to address device changes and when to file a new 510(k). Who Will Benefit: This webinar will provide valuable assistance to all regulated companies performing and documenting meaningful, results driven 510(k) analysis and preparation / submission activities, based on the FDA's current guidance documents. It will briefly discuss how companies can best address changes to devices already cleared - whether or not a new 510(k) filing is warranted. Note: Use coupon code NB5SQH8N and get 10% off on registration.
  • 62 Request Info

    Introduction to Root Cause Investigation for CAPA

    This CAPA training program will provide an understanding of FDA and ISO requirements, steps in CAPA process and the challenges associated to root cause analysis. Attendees will learn the tools and quality data sources to use during root cause analysis investigation. Who Will Benefit: CAPA Owners Quality Assurance/ Quality Control Personnel Regulatory Compliance Professionals Document Control Personnel Regulatory Affairs Professionals Instructor Profile: Vanessa Lopez, Sr. Principle Quality, Regulatory and Compliance Consultant, has held a wide variety of leadership roles in the Medical Device (Class: I, II, and III), Pharmaceutical (API; Finished Product) and Environmental regulated industries as well as the Consulting Services industry. She has worked for Edwards LifeSciences, Roche Diagnostics, Eli Lilly, Pall LifeSciences, among others. Note: Use coupon code NB5SQH8N and get 10% off on registration.
  • 63 Request Info

    Biocompatibility Testing for Medical Devices : One and a Half Day In-Person Seminar

    The medical device field is one of the most heavily regulated industries, for obvious reasons. Medical devices are an important tool in efforts to improve patient care and treatment outcomes. Learn how to achieve more successful biocompatibility testing outcomes by attending this seminar. Note: Use coupon code < REFERRAL10 > and get 10% off on registration.
  • 64 Request Info

    Applied Statistics for QA, QC, Manufacturing, and Design Control

    The 2-day seminar begins with an examination of ISO and FDA regulations and guidelines regarding the use of statistics. Basic vocabulary and concepts are then reviewed and discussed. The flow of subsequent topics over the 2 days is as follows: • How to calculate confidence intervals (for proportions and for measurements), including a discussion of how to choose sample size • How to perform an interpret t-Tests, including consideration of "significance", "p-values", "power" and sample-size considerations • How to perform calculation of confidence/reliability for attribute data
  • 65 Request Info

    Validation and 21 CFR 11 Compliance of Computer Systems: Intermediate to Advanced

    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
  • 66 Request Info

    Problem Solving and Root Cause Analysis - the Key to an Effective CAPA System

    This program is designed to provide participants with: • Understanding and developing an effective Corrective and Preventive Action System • An understanding of a structured problem solving process • Tools and techniques to perform root causes analyses • The use of facts and data to eliminate the use and identification of ineffective solutions.
  • 67 Request Info

    Statistical Techniques for Medical Device Manufacturers

    The FDA's Quality System Regulation (QSR) requires device manufacturers to identify valid statistical techniques to "establish, control, and verify the acceptability of process capability and product characteristics." When device manufacturers analyze CA&PA; information, they must also use "appropriate statistical methodology". Some manufacturers are not clear about all of this. Others are nervous that their approach is sufficient. In addition, sampling plans must be valid, documented, adequate, and reviewed based on changes. These issues can create a patchwork of techniques without a coherent methodology. This seminar helps resolve the problem.
  • 68 Request Info

    Effective and Efficient Internal and Supplier Quality System Auditing for Medical Devices

    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.
  • 69 Request Info

    Medical Device Software Development

    This seminar is mainly based on the IEC62304:2006 standard and will introduce the main elements and requirements for the development of modern software systems for medical devices. Emphasis is placed on understanding the underlying principles that generate the requirements of the standard, to understand strengths, the shortcomings and weak parts of the standard and give practical, proven guidance on how to implement the requirements necessary for regulatory approval. This seminar goes beyond teaching the mere content of the standard, but will provide the toolset to understand the underlying engineering principles that allow a justifiable interpretation of potential ambiguities of regulatory requirements. Understanding the basic principles of risk management, the failure modes of software, the architectural approaches available to mitigate software failures and the understanding of test methodologies are vital components to understand the 'spirit' of the requirements.
  • 70 Request Info

    Software Risk Analysis Tools for Medical Devices and Risk Mitigation

    The FDA recalls related to software performance are on the increase for at least five years at the time of this writing. Software failures were behind 24 percent of all the medical device recalls in 2011, according to data from the FDA. Similar to hardware, software also has hazards (any source of harm) and hazardous situations which transform a hazard into harm. We must identify hazards and identify what event can turn them into harm and write software specifications to prevent such combinations. The risk management tools such as FMEA (Failure Mode and Effects Analysis), FTA (Fault Tree Analysis) can help to mitigate software risks. These tools are covered in the Chapter 4. The mitigations from using the tools become the new requirements in the software specification
  • 71 Request Info

    Extracting Information from Geochemical Data

    Most specialists strongly recommend to sample every meter of the drill core or of a trench and to use multi element analysis, rather than just asking the laboratory for gold test. There are also many other types of analysis that are ignored by the industry. But even when such analyses are requested, most of the time the fed geologist is not well trained on the necessary techniques and methods to extract all the information contained in the data. This seminar will teach you what to ask and how to extract all the important information of your data
  • 72 Request Info

    Problem Solving and Root Cause Analysis - the Key to an Effective CAPA System

    This program is designed to provide participants with: • Understanding and developing an effective Corrective and Preventive Action System • An understanding of a structured problem solving process • Tools and techniques to perform root causes analyses • The use of facts and data to eliminate the use and identification of ineffective solutions. An 8-Step Process is presented during the program, consisting of: 1. Identify the Problem 2. Identify the Team 3. Contain the Problem 4. Describe the Problem 5. Identify Possible Causes 6. Identify Root Cause 7. Implement Corrective/Preventive Action 8. Measure and Monitor Results
  • 73 Request Info

    Seminar on Validation and 21 CFR 11 Compliance of Computer Systems: Intermediate to Advance

    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
  • 74 Request Info

    The A to Z's of Microbial Control, Monitoring, Validation and Troubleshooting of Pharmaceutical Water Systems at Sydney, Australia

    Course "The A to Z's of Microbial Control, Monitoring, Validation and Troubleshooting of Pharmaceutical Water Systems " 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 is designed to provide a microbiology-focused education about all aspects of water systems and how biofilm manages to thrive there. Prior microbiological education or training, though a plus, is not a requirement because engineers and other non-biologists also need this training if they are involved with any aspect of water systems. The instructor will provide the necessary background needed to understand this very important subject matter. This understanding is essential to the proper design, validation, operation, monitoring, maintenance, troubleshooting, and excursion investigations of a high purity water system.
  • 75 Request Info

    Seminar on The A to Z's of Microbial Control, Monitoring, Validation and Troubleshooting of Pharmaceutical Water Systems at Zurich, Switzerland

    Overview: This course is designed to provide a microbiology-focused education about all aspects of water systems and how biofilm manages to thrive there. Prior microbiological education or training, though a plus, is not a requirement because engineers and other non-biologists also need this training if they are involved with any aspect of water systems. The instructor will provide the necessary background needed to understand this very important subject matter. This understanding is essential to the proper design, validation, operation, monitoring, maintenance, troubleshooting, and excursion investigations of a high purity water system. Without this understanding, water system control consists of a set of rules that often don't work and can cause very costly system downtime or even product recalls, and leaves the user without a clue as to what went wrong or how to effectively fix it so it doesn't recur.
  • 76 Request Info

    Seminar on Compliance Software Solutions for Medical Devices at Singapore

    Course "Compliance Software Solutions 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: Software's level of complexity and use is expanding at exponential levels. Likewise the potential risks to health follow suit. Problems with software create a number of different hurdles. Software may be a standalone device, control a device's performance, make calculations, identify treatment options or begin to play a more active role in making clinical decisions regarding patient management and treatment. FDA's risk classification will gradually clarify how it intends to manage the health risks. Software use has become increasingly complicated with the expansion of software applications, for example: cybersecurity, interoperability, mobile medical "apps," home use and remote use.
  • 77 Request Info

    Software Risk Analysis Tools for Medical Devices and Risk Mitigation at San Diego

    Overview: The FDA recalls related to software performance are on the increase for at least five years at the time of this writing. Software failures were behind 24 percent of all the medical device recalls in 2011, according to data from the FDA. Similar to hardware, software also has hazards (any source of harm) and hazardous situations which transform a hazard into harm. We must identify hazards and identify what event can turn them into harm and write software specifications to prevent such combinations. The risk management tools such as FMEA (Failure Mode and Effects Analysis), FTA (Fault Tree Analysis) can help to mitigate software risks. These tools are covered in the Chapter 4. The mitigations from using the tools become the new requirements in the software specification
  • 78 Request Info

    Effective and Efficient Internal and Supplier Quality System Auditing for Medical Devices at Los Angeles, CA

    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.
  • 79 Request Info

    Seminar on Complaint-Handling, MDR and Recall Management at Los Angeles, CA

    Overview An effective complaint handling system is an extremely important part of any quality system. Manufacturers should understand that any complaint received on a product shall be evaluated and, if necessary, thoroughly investigated and analyzed, and corrective action shall be taken. The results of this evaluation should lead to a conclusion regarding whether the complaint was valid, what the root cause of the complaint was, and what action is necessary to prevent further occurrences. Complaints cannot be ignored. They are an excellent indicator of problems with the use, design, and/or manufacture of a product. A single complaint that is thoroughly investigated may lead a company to take remedial or corrective action. It may also take an ongoing analysis of numerous complaints before a trend is spotted that causes a company to initiate changes in their product, labeling, packaging or distribution.
  • 80 Request Info

    Seminar on HIPAA, Mobile Devices, and Communications - Compliance and Using New Technologies for Healthcare Communications at SFO, CA

    Overview With the recent advances in portable technology, more and more organizations and their users are taking advantage of mobile devices to save time and get work done more efficiently. Texting, portable e-mail, and Apps are revolutionizing the ways health care providers interact with their patients and get their work done. But the use of these devices comes with hidden costs of compliance, especially if they lead to a reportable breach under HIPAA or state laws. HIPAA Privacy and Security Officers have been struggling to keep up with the use of the devices to protect patient privacy and avoid compliance issues. Even if these devices aren't in formal use in your organization, you need to act now to anticipate their use and make sure they are used properly.