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Courses

  • 421 Request Info

    A Bulletproof, Cost-Efficient Supplier Management Program

    This webinar will review in detail the FDA QSR and ISO requirements for supplier evaluation and assessment, and discuss cost effective options for many of the common practices for achieving compliance. Why Should You Attend: Supplier qualification and assessment is required according to both QSR regulations and ISO standards. Who Will Benefit: This webinar will provide valuable assistance to all regulated companies that are interested in implementing a supplier management program that is both compliant and cost-efficient. The employees who will benefit include: Purchasing management Regulatory management QA management Consultants Instructor Profile: Jeff Kasoff, RAC, is the director of quality at Medivators, a leading manufacturer of endoscopy consumables and instrumentation. Use coupon code 232082 and get 10% off on registration.
  • 422 Request Info

    UDI Implementation

    This webinar on UDI implementation will discuss the new requirements set by FDA for Unique Device Identification. Attendees will learn to overcome hurdles in implementing the new process and learn best practices too. Why Should You Attend: The US FDA issued the final regulations for Unique Device Identification (UDI). Now is the time for manufacturers to start implementation planning. Who Will Benefit: This webinar will benefit the professionals working in medical device industries. Regulatory managers Design engineers Labeling specialists Project managers Instructor Profile: Daniel O' Leary is president of Ombu Enterprises, LLC, a company offering training and execution in operational excellence, focused on analytic skills and a systems approach to operations management. Use coupon code 232082 and get 10% off on registration.
  • 423 Request Info

    Export Certificates for Medical Devices

    Certificates to Foreign Governments are the most frequently requested type of export certificate, but export certificates may also be requested when exporting devices under sections 801(e)(1) and 802 of the FD&C Act or when exporting non-clinical research-use-only devices. Who Will Benefit: Purchase department personnel Sales/marketing personnel Export managers/supervisors Business operations personnel Customs brokers Instructor Profile: Angela Bazigos is the CEO of Touchstone Technologies Silicon Valley, Inc. She has 30 years of experience in the lifescience industry spanning project management, quality assurance and regulatory affairs and has a patent aimed at speeding up software compliance. Use coupon code 232082 and get 10% off on registration.
  • 424 Request Info

    Complaint Handling in Compliance with FDA and ISO Regulations

    This training will detail how you can handle customer complaints in compliance with FDA and ISO regulations. The instructor will discuss topics like best practices for documenting customer feedback, what constitutes a complaint, what to do with non-complaint feedback, and how to include complaint trending into your firm’s CAPA program. Who Will Benefit: This webinar will provide valuable assistance to all regulated companies, since complaint handling is a regulatory requirement across the medical device, diagnostic, pharmaceutical, and biologics fields. The employees who will benefit include: Regulatory management personnel QA management personnel Customer service personnel Instructor Profile: Jeff Kasoff, RAC, is the director of quality at Medivators, a leading manufacturer of endoscopy consumables and instrumentation. Use coupon code 232082 and get 10% off on registration.
  • 425 Request Info

    You have a Sterility Failure or Bioburden Excursion - Now What?

    This webinar on sterility or bioburden test for medical devices will discuss about the various items that should be investigated to determine the root cause, when a failure occurs during a sterility test, and the follow up to the investigation. Why Should You Attend: All sterile products require some level of sterility and bioburden testing during validation and then during routine production. What actions your company takes when this testing exhibits results that do not meet specifications can be critical from a regulatory and safety standpoint. Who will Benefit: QA personnel Validation specialists Manufacturing personnel involved in validations Instructor Profile: Gerry O'Dell, is owner and President of Gerry O'Dell Consulting, a consulting firm based in the United States with medical device and pharmaceutical clients around the world. Use coupon code 232082 and get 10% off on registration.
  • 426 Request Info

    Statistical Concepts of Process Validation

    This process validation training will look at the underlying statistical concepts to perform an effective process validation. The webinar will examine elements of the FDA regulations for process validation (21 CFR 820.75) as well as the corresponding requirements in ISO 13485. Who Will Benefit: This webinar is for people involved in the validation of production processes. Validation requirements start in the design output (setting the requirements), continues to design transfer (where the requirements are set as process parameters), and finally to process validation to ensure the resulting output achieves the requirements. People in the following roles can especially benefit from this webinar: Quality Managers Quality Engineers Production Managers Instructor Profile: Daniel O'Leary is the president of Ombu Enterprises, LLC, a company offering training and execution in operational excellence, focused on analytical skills and a systems approach to operations management.
  • 427 Request Info

    FDA's Medical Device Software Regulation Strategy: 2-Day In-Person Seminar by Ex-FDA Official

    Course Description: The growth of the medical software industry outpaces the design of FDA's regulatory process. In some instances clinicians have weighed the risk of software failure against the benefits of using a device at all. Device software is often used in conjunction with other software-based devices, but their interoperability was never anticipated. How can you anticipate and defend against the malicious remote hacking and shut down of an insulin infusion pump? Can one software program defeat the performance capability or back up safety features of another software program? Who Will Benefit: Regulatory Affairs Managers Quality Assurance Managers Software Design Engineers Manufacturing Managers Compliance Department Personnel Hospital Risk Department Personnel
  • 428 Request Info

    Effective and Efficient Internal and Supplier Quality System Auditing for Medical Devices: 2-day In-person Seminar

    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? Do you need to train new auditors for your medical device quality management systems or to audit your suppliers? Do you need to improve the training of your internal and supplier auditors so that they add value to these audits? Who Will Benefit: This course is designed for people who perform or manage audits of a medical device quality management system, including internal and/or supplier audits. Both 21 CFR 820 Quality Systems Regulation (cGMP), and ISO 13485 and Quality Management Systems auditing will be covered. Senior quality managers Quality professionals Regulatory professionals
  • 429 Request Info

    Medical Device Risk Management A to Z - Best Practices for Effectiveness and Efficiency: 2-day In-person Seminar

    FDA views risk management as an essential process both during inspections and in the review of pre-market submissions. Effective risk management has become critical to medical device manufacturers and this interactive two day seminar is aimed at providing medical device professionals with the tools necessary for effective risk management implementation in device manufacturing and marketing. Learning Objectives: To educate attendees on the vital reasons for risk management and the key role it plays in the product life cycle To demonstrate the requirements of ISO 14971, how they reflect FDA concerns Who will benefit: Project managers Quality managers and staff R & D managers and staff Regulatory and compliance managers and staff Anyone with risk management responsibilities Note: Use coupon code NB5SQH8N and get 10% off on registration.
  • 430 Request Info

    The 510(k) Process: Evaluating Substantial Equivalence in Premarket Notifications

    Each 510(k) submission poses a new set of challenges and new variations, depending on the type of device, the risk level, and its history. Therefore, it is essential to have a strong understanding of the most up-to-date 510(k) submission requirements and how they relate to your device for the most efficient submission process. Why Should You Attend: The process of compiling and submitting a 510(k) for medical device companies, especially small companies, can be ambiguous. It requires considerable investment of time and resources. Toiling through this process can be overwhelming and also a constant struggle with bureaucratic hurdles. Who Will Benefit: Regulatory Affairs Quality Assurance Compliance Research and Development Instructor Profile: With a double major in mechanical engineering and mathematics and a master’s in biomedical engineering, Ana Maria Saaibi has more than 6 years of medical device experience in both product development and quality and regulatory affair
  • 431 Request Info

    Supplier Management for Medical Device Manufacturers: 2-day In-person Seminar

    Supplier selection and management is one of the critical issues for medical device manufacturers. Suppliers provide components to the device manufacturer, which means that they are critical to performance and delivery. 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. Learning Objective: Upon course completion, participants will: Understand FDA QSR and ISO 13485 requirements for supplier management Understand the FDA’s multi-tier supplier classification system Understand when suppliers have to register and list with the FDA Who will Benefit: Quality Managers Supply Chain Managers Quality Engineers Supplier Quality Engineers Purchasing Professionals Regulatory Specialists Production and Process Engineers Note: Use coupon code NB5SQH8N and get 10% off on registration.
  • 432 Request Info

    Verification vs. Validation in Regulated Industries by John Chapman

    Areas Covered in the Webinar: Verification & validation types. Definitions. Design control. Process control. Application. Consequences of poor verification & validation. Why verification & validation makes good business sense?
  • 433 Request Info

    Medical Device Risk Management A to Z - Best Practices for Effectiveness and Efficiency by Dr. Harvey Rudolph, HRRM, LLC (Ex-FDA Official, ISO 14971 S

    Learning Objectives: To educate attendees on the vital reasons for risk management and the key role it plays in the product life cycle To demonstrate the requirements of ISO 14971, how they reflect FDA concerns To clarify how risk management impacts international standards, such as IEC 60601, and how to conform to risk management requirements To provide practical application experience and skills in the process and tools of risk management, enabling attendees to be effective risk managers To teach how to establish a quantitative risk management system and one that complies with EN/ISO 14971:2012 To provide attendees with the Dos and Don'ts for an effective and efficient risk management system.
  • 434 Request Info

    Post-Market Compliance for Medical Devices and Evolving Reporting Requirements: Complaint Handling, MDR/eMDR and Recalls including UDI update

    This interactive one and a half day course led by Ms. Rita Hoffman, Former FDA CDRH Recall Branch Chief, who has more than 36 years’ experience with the FDA will provide the participants tools to minimize risk of regulatory enforcement actions. Learning Objectives: Understand how to comply with complicated Compliant Handling, MDR and Recall requirements. Firms MDR reporting and FDA's handling of reports. Company preparation in the event of a Recall, recall strategy, notification letter and communicating with the FDA. Who will Benefit: This course will benefit anyone in the medical device industry that handles functions involving product complaints, recalls, medical device reporting. Regulatory Affairs QA/QC Project Managers Regulatory Professional Risk Managers Note: Use coupon code NB5SQH8N and get 10% off on registration.