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Courses

  • 21 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.
  • 22 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.
  • 23 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.
  • 24 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.
  • 25 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.
  • 26 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.
  • 27 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.
  • 28 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.
  • 29 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. 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 Production engineers R&D engineers 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. For Registration: http://www.complianceonline.com/equipment-calibration-maintenance-and-validation-for-auditors-webinar-training-701786-prdw?channel=trainingregistry
  • 30 Request Info

    Using an IQ / OQ / PQ Approach to Validating Medical Device Software

    This medical device software validation training will show how you can validate software using IQ / OQ / PQ methodologies, typically employed for medical device process validation. Who Will Benefit: This webinar will provide valuable assistance to medical device companies in performing verification and validation testing throughout the product lifecycle. The employees who will benefit include: Systems Engineers Software testers Test Engineers Quality System Auditors Instructor Profile: Mercedes Massana, is the founder and CEO of MDM Engineering Consultants, a consulting firm that provides engineering and quality consulting services in the medical device, biotechnology, and pharmaceutical industries. Mercedes has over twenty-five years of experience in the Medical Device industry. Note: Use coupon code 232082 and get 10% off on registration.
  • 31 Request Info

    Design Control for Professionals

    This training program will focus on the consequences of poor design control, Failure Modes Effects Analysis (FMEA), design control segments, and more. Design control has been a legal requirement for over 30 years, yet many firms fail to take full advantage of a controlled method for introducing new products or changing existing products costing millions of dollars and injuring both patients and health care professionals. Who Will Benefit: R&D Personnel Design Engineers Validation Engineers Regulatory Professionals Instructor Profile: An independent QMS consultant, John Chapman, BS, MBA, RAC has over 35 years medical device QMS (Quality Management Systems) experience and over 20 years’ experience with the European Union’s medical device directive, 93/42/EEC. Note: Use coupon code 232082 and get 10% off on registration.
  • 32 Request Info

    Creating a Good Design History File (DHF) for Audit Success

    This DHF regulatory compliance training will discuss the structure of a good Design History File, elements to look for when auditing a DHF and how to address issues. Why Should You Attend: A Design History File (DHF) is a requirement of QSR 21 CFR Part 820. It is a certainty that in an audit from a regulatory body, information from the DHF will need to be provided. Who Will Benefit: This webinar will provide valuable assistance to medical device companies in managing their Design History Files. The employees who will benefit include: R&D Engineers Quality Engineers Regulatory Affairs Instructor Profile: Mercedes Massana, is the founder and CEO of MDM Engineering Consultants, a consulting firm that provides engineering and quality consulting services in the medical device, biotechnology, and pharmaceutical industries. Note: Use coupon code NB5SQH8N and get 10% off on registration.
  • 33 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.” Who Will Benefit: This webinar will benefit the following personnel in the medical device industry: Regulatory managers Project managers Staff involved with regulatory filings Product development managers 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. 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.
  • 34 Request Info

    Quality Assurance at the (Clinical Research) Site: How to Develop a Manageable Plan

    This clinical compliance training will help attendees understand how they can develop and implement a Quality Assurance (QA) program at their clinical research site that ensures the staff are properly trained and that the research is carried out in accordance with regulatory expectations. Who Will Benefit: This webinar will provide valuable assistance to following personnel: Experienced Clinical Research Coordinators Experienced Principal Investigators Experienced Clinical Research Associates (Monitors) Instructor Profile: Jennifer Holcomb, MA, CCRC, is a clinical research professional with over 20 years of experience in the field. Note: Use coupon code NB5SQH8N and get 10% off on registration.
  • 35 Request Info

    Verification vs. Validation in Regulated Industries

    This webinar on verification vs. validation will help you to understand the differences between, and benefits of, verification and validation in both design and process operations in regulated industries. Who Will Benefit: Companies wishing to understand the risks and complications involved with the application of sound verification and validation principles will gain a better understanding of the differences and benefits. Employees who will benefit include: Quality & Regulatory Professionals Manufacturing & Design Engineers Marketing Product Managers Corporate & Operations Executives Instructor Profile: John Chapman, BS, MBA, RAC has over 35 years medical device regulatory experience and over 15 years experience with the European Union’s medical device directive, 93/42/EEC. Note: Use coupon code 232082 and get 10% off on registration.
  • 36 Request Info

    Understanding the Mobile Medical Applications Guidance

    This medical device webinar will discuss the FDA guidance on Mobile Medical Applications and provide clarification on the primary points of the guidance. Who Will Benefit: This webinar will provide valuable assistance to following personnel in the medical device industry: Regulatory affairs Project managers Staff involved with regulatory filings Product Development managers 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. Note: Use coupon code 232082 and get 10% off on registration.
  • 37 Request Info

    Failure Mode and Effects Analysis for Design Improvement and Design Control

    In this failure mode and effects analysis training, attendees will learn how to design medical devices that enhance reliability, durability, safety, and serviceability. Who Will Benefit: This course is designed for all technical employees. This is particularly important for all managers because 85% device defects are said to be the result of poor management practices. The following personnel will benefit from the course: Senior managers Quality assurance supervisors Design engineers R&D engineers Instructor Profile: Dev Raheja, MS,CSP, author of the books Preventing Medical Device Recalls and Safer Hospital Care, is an international risk management, patient safety and quality assurance consultant for medical device, healthcare and aerospace industry for over 25 years. Note: Use coupon code 232082 and get 10% off on registration.
  • 38 Request Info

    Supplier Quality Agreements - Essential for Suppliers of Many Outsourced Processes

    This webinar will discuss in detail the use of the Global Harmonization Task Forces (GHTF) and Notified Body Operations Group (NBOG) supplier guidance documents to create QA agreements. Who Will Benefit: This webinar will provide valuable assistance to all personnel in: Quality Management Regulatory Affairs Supply-chain Management Supplier Engineering Instructor Profile: Betty Lane, has over 30 years’ experience in medical device quality assurance and regulatory affairs. Note: Use coupon code 232082 and get 10% off on registration.
  • 39 Request Info

    CE Mark - Required to Sell Medical Devices in the EU

    This webinar on selling medical devices in the European Union (EU) will immensely benefit companies wishing to penetrate the EU market for medical devices or sharpen their skills. Who will Benefit: Companies wishing to penetrate the EU market for medical devices or sharpen their skills will receive practical guidance on achieving the CE mark. Employees who will benefit include: Quality & Regulatory Professionals Manufacturing & Design Engineers Instructor Profile: John Chapman, BS, MBA, RAC has over 40 years’ medical device regulatory experience and over 20 years’ experience with the European Union’s medical device directive, 93/42/EEC. Note: Use coupon code 232082 and get 10% off on registration.
  • 40 Request Info

    Creating a Global Regulatory Plan

    This regulatory training will help attendees understand key benefits for implementing and maintaining an effective global regulatory plan. Who Will Benefit: This webinar will provide valuable assistance to following personnel: Regulatory managers Project managers Product development managers Marketing managers Instructor Profile: Cheryl Wagoner, has 20 years of experience in quality assurance, and regulatory affairs. Ms. Wagoner currently is 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.