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Courses

  • 401 Request Info

    Understanding the New Custom Device Exemption Guidance

    This training program will review the primary points of the new guidance and review §20(b) of the FD&C Act. It will offer a background of the Act and discuss current updates and changes to the same as well. Who Will Benefit: This webinar will provide valuable assistance to: Regulatory or quality assurance management personnel Project managers Staff involved with custom devices Instructor Profile: Cheryl Wagoner has 20 years of experience in quality assurance, and regulatory affairs. She is currently the principal consultant/owner of Wagoner Consulting LLC, where she provides consulting services to medical device and pharmaceutical companies. Previously, she has held various positions in quality, regulatory, clinical and compliance in the medical device and pharmaceutical industries. Note: Use coupon code 232082 and get 10% off on registration.
  • 402 Request Info

    Metrics and Dashboards for Quality and Compliance

    This training program will discuss the challenges faced by medical device companies amid close scrutiny by industry regulators. It will also offer best practices for combating lack of transparency in quality/compliance data. Who Will Benefit: Managers of quality and compliance Quality and compliance professionals in medical device companies Individuals preparing information for management review Instructor Profile: Susanne Manz, MBA, MBB, RAC, CQA, is an accomplished leader in the medical device industry with emphasis on quality, compliance, and Six Sigma. She has an extensive background in quality and compliance for medical devices from new product development, to operations, to post-market activities. She has a BS in Biomedical Engineering and an MBA from the University of NM. Note: Use coupon code NB5SQH8N and get 10% off on registration.
  • 403 Request Info

    How to Develop a Medical Device Design Control Program that Will Meet FDA Requirements

    This training program will offer attendees an understanding of the reasons for design control and highlight the key elements of a design control program. Why Should You Attend: This course will explain how to setup and manage a design program that will meet FDA requirements and minimize chances of your medical device being recalled. A design control program will also help ensure your projects are completed on time and within budget. Who Will Benefit: Personnel developing or managing medical devices Production management QA/QC Instructor Profile: Edwin Waldbusser is a consultant retired from the industry after 20 years in management of development of medical devices (5 patents). He has been consulting on regulatory issues related to design control, risk analysis and software validation for the last 7 years. Note: Use coupon code 232082 and get 10% off on registration.
  • 404 Request Info

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

    The course is designed for Medical Products Manufacturers. The course will be taught for Medical Devices and Combination Products, but will also be of benefit to Pharmaceutical Manufacturers. Who will benefit: The course is designed for manufacturing professional employees that must interface with or implement product risk management activities in a medical product manufacturing operation. Product Risk Managers Quality Assurance Regulatory Affairs Research & Development Project Managers Operations Managers Note: Use coupon code NB5SQH8N and get 10% off on registration.
  • 405 Request Info

    Do You Really Need To Do A Recall? If So, What Is Required?

    This training program will provide practical pointers on documenting the recall decision. Recall can be a very costly process for a manufacturer. It is really important from a regulatory perspective to properly document the decision process whether a recall is necessary or not. Who Will Benefit: This webinar will provide valuable assistance to all personnel in: Regulatory roles Quality assurance management Manufacturing management responsible for executing recall activities Instructor Profile: Cheryl Wagoner has 20 years of experience in quality assurance, and regulatory affairs. She is currently the principal consultant/owner of Wagoner Consulting LLC, where she provides consulting services to medical device and pharmaceutical companies. Note: Use coupon code 232082 and get 10% off on registration.
  • 406 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. Who Will Benefit: This webinar will benefit the professionals working in medical device industries. Regulatory managers Design engineers Labeling specialists Project managers Quality 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. Note: Use coupon code 232082 and get 10% off on registration.
  • 407 Request Info

    Navigating through Maze of In-vitro Diagnostics (IVD) Regulations: A systematic approach from Regulatory Strategy to Regulatory Approvals in U.S./Euro

    In-vitro Diagnostics (IVD) products provide critical information on patient’s health condition, based on which the healthcare provider develops and administers treatment plan. Although IVDs are medical devices, they are regulated under a separate set of regulations in U.S., Europe, and Canada. Who will benefit: This interactive course is specifically developed for individuals, who are responsible for the design, development, manufacturing, marketing, and distribution of IVD products. This course is highly recommended for personnel involved in any of the following functions: Department Managers (middle management) Research & Development (R&D) Product Design & Development Validation Engineering Regulatory Affairs Note: Use coupon code 232082 and get 10% off on registration.
  • 408 Request Info

    Troubleshooting Ethylene Oxide (EO) Processes

    This EO sterilization training Webinar will discuss the important parameters to measure for the sterility assurance level and actions to take if they are not compliant to the process specification. Why Should You Attend: Ethylene oxide (EO) sterilization is the most complicated of the industrial sterilization methods. It is not uncommon for anomalies to occur during qualification or routine processing. Who Will Benefit: This webinar will provide valuable information to all companies that produce sterile products. 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. Note: Use coupon code NB5SQH8N and get 10% off on registration.
  • 409 Request Info

    How to Achieve 510(k) Application Success for Device Software: Avoid Pitfalls that Could Delay Your Market Entry

    Though the guidance regarding software in medical devices is not new, there remains some confusion in the industry. This training program will offer some clarity on the subject, and upon completing this session, attendees will understand the elements required for a 510(k) application when the device contains software. Why Should You Attend: The webinar will discuss the structure and level of detail required when a medical device is software or contains software. It will especially focus on the impact of the Level of Concern determination on the required documentation. Who Will Benefit: Regulatory managers Project managers Regulatory specialists who compose 510(k) applications for software Instructor Profile: Cheryl Wagoner has 20 years of experience in quality assurance, and regulatory affairs. Note: Use coupon code 232082 and get 10% off on registration.
  • 410 Request Info

    Equipment Calibration, Maintenance, and Validation: What Auditors Look for in a Controlled Process

    This webinar will discuss the different aspects which auditors generally look in equipment calibration, maintenance and validation and highlight the best practices. Why You Should Attend: FDA and EU regulations require that firms have a program for the calibration and maintenance of test and measurement equipment. The program must include: intervals, scheduling, specific procedures, limits of accuracy/precision, and remedial action in the event that the equipment does not meet established requirements. Who Will Benefit: This webinar will provide valuable assistance to all personnel involved in process development or equipment calibration/maintenance: R&D management Engineering management Production management Instructor Profile: Jeff Kasoff, RAC, is the Director of Regulatory Affairs at Life-Tech, Inc., a leading manufacturer of consumables and instrumentation in the urodynamic and pain management fields. Note: Use coupon code 232082 and get 10% off on registration.
  • 411 Request Info

    21 CFR Part 820 Quality System Regulation - Applying Principles of Lean Documents and Lean Configuration

    This quality system regulation training will explain how to apply the theory of lean documents and its corollary theory of lean configuration to present a fresh approach to complying with 21 CFR Part 820. Why Should you Attend: If you are constantly struggling to create, manage, and maintain all of the information found in controlled documents, all of which are often redundant, repetitive, and clustered together in an awkward manner, this webinar is something that will give you a different perspective and a very different approach that you can use. Who Will Benefit: This webinar will provide valuable assistance to Managers, Supervisors, Directors, and Vice-Presidents in the areas of: R&D Manufacturing Engineering Design Assurance Instructor Profile: Jose Mora, is a Principal Consultant specializing in Manufacturing Engineering and Quality Systems. Use coupon code 232082 and get 10% off on registration.
  • 412 Request Info

    Navigating the New FDA Draft Guidance on ISO 10993: Biological Evaluation of Medical Devices

    The webinar will focus on the amendments made to the Blue Book Memorandum #G95-1 Use of International Standards ISO-10993, “Biological Evaluation of Medical Devices Part 1: Evaluation and Testing.” Why Should You Attend: In April 2013, FDA published a new draft guidance entitled Use of International Standard ISO -10993, “Biological Evaluation of Medical Devices Part 1: Evaluation and Testing.” Who Will Benefit: This webinar will benefit the following personnel in the medical device industry: Regulatory managers Project managers Staff involved with regulatory filings Instructor Profile: Cheryl Wagoner, has 20 years of experience in quality assurance and regulatory affairs. She currently is the principal consultant/owner of Wagoner Consulting LLC, where she provides consulting services to medical device and pharmaceutical companies. Use coupon code 232082 and get 10% off on registration.
  • 413 Request Info

    Monitoring and Measuring Customer Satisfaction Using ISO 10004:2012

    Although customer satisfaction is not deemed a critical area for medical device manufacturers, measuring and monitoring customer satisfaction can determine issues that hinder progress. This training session will elaborate the methods to identify customer expectations, list techniques to analyze customer satisfaction data, and cite preventive action for improvement. Why Should You Attend: Quality management systems (QMS), FDA QSR and ISO 13485:2003 do not require customer satisfaction measurements as regulators are not in a position to enforce it. Who Will Benefit: Quality Managers Regulatory Managers Sales Managers Marketing Managers Project 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.
  • 414 Request Info

    How to Investigate Environmental Monitoring Excursions

    This OOS investigation training will review the various items that should be included in the investigation to determine the cause of the limit excursion for both viable and non-viable excursions. Why Should You Attend: Medical products are manufactured in environments that control the level of viable and non-viable particulate and to establish that the control is taking place periodic monitoring must be performed. Who Will Benefit: This webinar will provide valuable information to all companies that manufacture medical products in environments that are controlled and monitored for viable or non-viable contamination. QA personnel Manufacturing R&D Instructor Profile: Gerry O'Dell, is president of Gerry O’Dell Consulting, a consulting firm based in the United States with clients around the world.
  • 415 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.
  • 416 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.
  • 417 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.
  • 418 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.
  • 419 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.
  • 420 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.