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Courses

  • 1 Request Info

    Exploring the FDA Refuse-To-Accept (RTA) Guidance for 510(k) Submissions

    The FDA has instigated a Refuse to Accept Policy and will no longer accept 510K submissions that do not meet a minimum threshold of acceptability. By doing so, the Center for Devices and Radiological Health, will be able to focus substantive review on submissions that are complete. It is expected that 510(K)s that are accepted under this new policy, will be reviewed more quickly.
  • 2 Request Info

    Managing Complaints, Small Business Perspective

    This webinar will review GMP requirements for complaint handling. We will also discuss the types of complaints (adverse and non-adverse events) that may be received. You will learn about the key components in managing complaints such as tracking the complaint from time of receipt to completion, initiating and performing a complaint investigation, evaluating the complaint for medical device reporting, final review of the complaint and investigation and preparing a response to the complainant.
  • 3 Request Info

    The 7 Habits of Highly Effective Project Managers

    Overview: Too often Project Leaders and Managers fall into the role due to demonstrated technical competence. After all, if you're competent enough to create great technical output, certainly you can figure out how to run a project on schedule and within budget, right? And even when you get an opportunity to attend training to become a better Project Manager, the focus is on the "hard" or technical aspects of project management rather than the "soft" skills or habits that typically only come with experience.
  • 4 Request Info

    EU ISO 13485:2016 Medical Device Quality Management System

    This webinar will examine the changing focus of medical device regulation, similarities and differences between ISO 13485 and 21 CFR 820 (FDA's Device CGMPs), We will establish the correct definition of "risk", tied to ISO 14971 which has led to some major issues with companies selling to both the US and the EU.
  • 5 Request Info

    21 CFR Part 11 - Compliance for Electronic Records and Signatures

    This Webinar will explain what 21 CFR Part 11 is, why it is important to FDA regulated companies and how conformance to Part 11 differs from just having good IT security. Procedures for controlling electronic signatures and electronic records as described in the FDA Guidance will be explained. FDA regulated companies want to transition to electronic records for economy and efficiency. FDA, because of its concern for patient safety, wants to prevent electronic records from being compromised with possible resulting harm to the patient. FDA has set up regulations that address both data security and patient safety. We will show how 21 CFR part 11 considers both.
  • 6 Request Info

    Quality Management Systems for Medical Devices

    This webinar presents to the participants the new requirements of the standard and how they correlate with the regulatory changes in the EU. Prior to engaging the process of establishing and certifying a QMS for medical devices or enhancing the QMS to the newly introduced requirements, a review of those requirements and how to approach them is important.
  • 7 Request Info

    Risk Management in Medical Device Design

    Overview: The webinar will explore the basic principles of risk management and planning as they relate to medical device design and as required by the FDA. It will present a logical process for risk management from risk identification through evaluation/rating and mitigation. Why should you Attend: The secret to preventing medical device recalls or at least to minimizing their impact is sound Risk/Hazard Analysis. Aside from being required, it is absolutely essential and necessary to the development and fielding of medical devices that offer a significant level of protection for patients and manufacturers alike.
  • 8 Request Info

    Accelerated Aging Techniques for Medical Device Packaging

    Accelerated aging (AA) is testing that uses aggravated conditions of heat, oxygen, sunlight, vibration, chemicals, etc. to speed up the normal aging processes of items. It is used to help determine the long-term effects of expected levels of stress within a shorter time, usually in a laboratory by controlled standard test methods. AA is used to estimate the useful lifespan of a product or its shelf life when actual lifespan data is unavailable. The ability of product designers to accurately predict changes in polymer properties is of critical importance to the medical device, consumer, and industrial markets.
  • 9 Request Info

    Skills and Competencies Needed to Succeed in Today's Workplace

    What critical thinking means Why it's important How it relates to you in the workforce How better thinking skills can help you How you can learn to think critically to make decisions and set goals To examine the fundamentals of critical thinking, problem solving, decision making and goal setting To explore the relationship between critical thinking and career self assessment To help participants make informed and wise decisions To help participants approach problem solving and decisions making effectively
  • 10 Request Info

    Industry Best Practices for a Learning Culture

    The first is the ability to design the organization to match the intended or desired outcomes, and second, the ability to recognize when the initial direction of the organization is different from the desired outcome and follow the necessary steps to correct this mismatch. Organizations that are able to do this are exemplary.
  • 11 Request Info

    Webinar on Simplified CAPA Process - 21 CFR Subpart J of FDA Regulations

    Learn 21 CFR subpart J of FDA regulations related to CAPA, how to integrate CAPA with other branches of QMS. Register today for this webinar. Price:$200.00. Contact info : OnlineCompliancePanel Phn. no. +1-510-857-5896 Fax-+1-510-509-9659 info@onlinecompliancepanel.com Event link - https://www.onlinecompliancepanel.com/webinar/CAPA-Simplified-A-One-Form-Easy-To-Complete-Method-for-Simplifying-Your-CAPA-Process-505214/JULY-2019-ES-TRAININGREGISTRY
  • 12 Request Info

    Webinar on Hazard Analysis Following ISO 14971- Risk Management

    In this webinar we will explain in detail the process of conducting a hazard analysis and how to integrate hazard analysis into the design program. Join today. Price:$200.00. Contact info : OnlineCompliancePanel Phn. no. +1-510-857-5896 Fax-+1-510-509-9659 info@onlinecompliancepanel.com Event link - https://www.onlinecompliancepanel.com/webinar/Hazard-Analysis-Following-ISO-14971-509891/JULY-2019-ES-TRAININGREGISTRY
  • 13 Request Info

    Webinar on Preventing Human Error in the Life Sciences

    Explore the true causes and nature of human error, how human error should be investigated, how human error relates to human performance. Price:$200.00. Contact info : OnlineCompliancePanel Phn. no. +1-510-857-5896 Fax-+1-510-509-9659 info@onlinecompliancepanel.com Event link -https://www.onlinecompliancepanel.com/webinar/Preventing-Human-Error-in-the-Life-Sciences-509812/JULY-2019-ES-TRAININGREGISTRY
  • 14 Request Info

    Risk Management in Medical Devices Industry:2-Day In-Person Seminar

    Risk management is a mandatory and necessary process during the entire device life. Not only will it help to design and maintain devices efficiently, but it also ensures that the device will be as safe as possible and prevents harms to patients, users, and the environment. Like any process that tries to produce repeatable and consistent results, the risk management process must be clearly understood, including the strengths but also the limitations. By attending this seminar you will learn the main elements of ISO 14971, ISO 13485, IEC62304, IEC62366-1/-2, risk management life cycle steps and benefits, and FDA software reviewers' guidance.
  • 15 Request Info

    Managing Your Complaints and Obstacles in Post-Market Requirements -- Results from Top Medical Device Observations During an Inspection

    Post-Market activities, Complaint Handling, MDRs, and Recalls are expensive, time consuming, and often lead to more serious financial consequences. Over 80% of FDA Inspection target observations for lack of compliance in these areas.
  • 16 Request Info

    Implementing UDI (Unique Device Identification) - Plan Now for Success:One Day In-Person Seminar

    The one-day workshop provides the information you need to implement UDI. An effective implementation gives your customers the information they need. It will also help you avoid an FDA 483 and a Warning Letter. The workshop gives you hands on experience to understand UDI and your device. You bring a laptop computer and some information about your device. During the seminar you receive toolkits to determine the compliance dates, packaging configurations, and the attributes you will load to GUDID
  • 17 Request Info

    Software Validation for Medical Instrument Development [Introduction]

    Overview: This is an introduction to software validation for medical device development targeted to software developers, engineers, testers and managers. It covers simple and small projects to mid-size projects including development projects and manufacturing projects. It will be useful for new hires in any of these functions and for persons assigned to audit the validation results. Why should you Attend: There are several key elements that need to be included in your instrument Validation and Verification efforts to ensure compliance with FDA and EU IVDR (In-Vitro Diagnostics Regulation). The new regulations have added many new requirements that translate to new deliverables your testing report must provide.
  • 18 Request Info

    Investigation and Root Cause Analysis to Meet FDA Expectations

    Defined Failure Investigation and Root Cause Analysis is a major tool in product complaint, non-conformance, and OOS failure investigations, and hazard analysis / risk management and mitigation activities, the basic foundation of a viable CAPA system. It is required in resolving verification and validation issues including data outliers that frequently but are often improperly dismissed arbitrarily. It is required in order to "close-the-loop" on corrective and/or preventive actions (CAPA), and do proper impact analysis / actions. Such failure investigation and root cause analysis is a major element of cGMP compliance.
  • 19 Request Info

    6-Hour Virtual Seminar on Transition from Peer to Supervisor

    Today's workforce is experiencing high turnover and disengaged employees. It is a known fact that employees quit managers- to avoid turnover it is critical to have the appropriate skills to retain employees. Transition from a Peer to Supervisor can be very difficult for most newly promoted supervisors. Many are not equip with the tools to successfully transition. This seminar will equip newly promoted supervisor with tools and techniques to decrease turnover, increase employee engagement and increase employee productivity.
  • 20 Request Info

    6-Hour Virtual Seminar on FDA Scrutiny of Promotion and Advertising Practices

    If you go "off label" with advertising and promotion, FDA's hammer can hit hard and seemingly out of the blue. Advertising and promotion for devices is weak and lacks legal clarity. For drugs, the regulations are prescriptive and guidance documents clamp down on nuances. Marketing and regulatory affairs departments must collaborate to avoid the hammer and penalties of FDA. The roadblock, however is that marketing managers and regulatory affairs managers rarely reach common ground and are loathe to even consult with each other.