Medical Devices

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  • 121 Request Info

    Conference on why FDA at my Facility is, and what do I do During an Inspection

    Many regulated companies preparing for FDA inspections are not prepared and the outcome can be negative as we see all the time with enforcement actions. This seminar provides the fundamentals and the ground rules on how to prepare for and survive an FDA inspection no matter if you are a Class I, II, III device or a pharmaceutical or biologics manufacturer. This presentation will review and emphasize the do's and don'ts and cardinal rules as to interviewing, how to respond, reviewing documentation, etiquette, use of certain words, body language, responding to questions/requests, etc., and certainly replying to 483's and Warning Letters. Emphasis is placed on the company's SOP on dealing with inspectors and knowing how to be prepared, proactive...and being able to defend and justify... and what it takes to achieve a favorable outcome.
  • 122 Request Info

    Seminar on Complaint Handling and Management: From Receipt to Trending

    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.
  • 123 Request Info

    Online Webinar on FDA Regulation of Medical Device Software

    Overview: The Food and Drug Administration (FDA) was not empowered by Congress to regulate medical devices until May 28, 1976 when the Medical Device Amendments were added to the Federal Food, Drug, and Cosmetic Act (FDCA). Computer software was in a state of infancy during the 1970's and the role computer software would eventually play in the provision of healthcare was not foreseen. FDA did not have to create a software regulatory policy until the late 1980's when companies began incorporating primitive software programs in medical devices.
  • 124 Request Info

    Online Webinar on Update on Unique Device Identifier for Device Manufacturers

    Overview: Recent reports identified several potential benefits to widespread use of UDI, such as reducing medical errors, facilitating recalls, improving medical device reporting, and identifying incompatibility with devices or potential allergic reactions. The reports further indicated that many issues have to be addressed prior to successful implementation of UDI for devices, including determining the technology needed to utilize UDI effectively, identifying the data needed for patient safety; development, maintenance, and validation of a central data repository; and harmonizing UDIs for the international marketplace.
  • 125 Request Info

    Online Webinar on Understanding, Calculating, and Using Statistical Power

    Overview: Statistical power is an indicator of the ability of a test of significance to "detect" a practical difference (e.g., between the averages of two products that are being compared). A low power typically means that the sample sizes in the study are too small. Without an analysis of statistical power, a conclusion of "non-significant" is rightfully questionable. Unless power is high, a study may be doomed to failure even before it is begun. This webinar provides thorough training in how to interpret and use the power-analysis outputted by text-book calculations or software programs modules (e.g., StatgraphicsCenturionXV).
  • 126 Request Info

    Conference about Materials Selection for Radiation Sterilized Medical Products

    Review of basic polymer chemistry and changes in polymer characteristics can be anticipated and designed for. Learn how to plan for post radiation resistance and lifetime functionality. All radiation modalities (gamma, e-beam, x-ray) will be reviewed for a basic understanding of the sterilization process and the influences that product design and assembly can have on success.
  • 127 Request Info

    Conference about Medical Device Recalls

    Companies need to remain vigilant in understanding and applying current FDA law and regulation pertaining to the marketing of their devices in the US. Failure to do this raises their regulatory risk and hampers their ability to stay competitive in the rapidly advancing technological world of medical device manufacturing and marketing. Effectively managing recalls reduces regulatory risk and allows problem recovery to begin more quickly. The stakes are high and growing even higher as device regulatory authorities around the globe are harmonizing their regulatory standards and requirements while increasing their collaborative efforts to ensure product safety. A part of the safety equation is looking at recalls. This seminar will explore key concepts in helping your company stay ahead of the regulatory curve by understanding FDA operations and developing effective mitigations to reduce risk in the recall area.
  • 128 Request Info

    Fremont 2016 Webinar on Good Documentation Practice for GxP Environments

    Overview: This webinar will cover Good Documentation Practice for GxP environments. This webinar will explore what companies need to know to comply with regulations regarding documentation, what Good Documentation Practice (GDP) is, what needs to be documented, why it is documented, and FDA expectations for documentation.
  • 129 Request Info

    How to Manage a Medical Device Recall by Compliance4all

    Overview: This webinar will provide valuable assistance and guidance to medical device firms that are either going through or preparing to go through a recall and want to understand the strategy and expectations of a recall and FDA's involvement. Recall means the correction or removal of a device for human use where FDA finds that there is a reasonable probability that the device would cause serious, adverse health consequences or death. It is an action taken to address a problem with a medical device that violates FDA law. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.
  • 130 Request Info

    The Investigational Medicinal Product Dossier

    Overview: This 90 minute training course will provide your company the opportunity for comprehensive understanding of the IMPD (Investigational Medicinal Product Dossier) and the structure and content differences between a EU CTA Application and an FDA IND Application. Additionally, this webinar covers many related processes sponsors will need to know, as they file for, conduct and close-out effective clinical studies in the U.S. and EU.
  • 131 Request Info

    Device Changes, FDA Changes, and the 510(k)

    The majority of medical devices are cleared for marketing in the U.S. by the FDA under the 510(k) process. The FDA holds companies responsible for filing new 510(k)s when one change is major enough to impact safety / effectiveness, or when a series of lesser changes finally reach the "tipping point". This is a major headache. How can companies make that determination? How can they trigger such an analysis over the major change or the series of smaller changes.
  • 132 Request Info

    Conducting Successful Product Complaint Investigations

    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. Areas Covered in the Session: Understand how and why CAPA is tied in to product complaint investigations Examples of tools currently being used to conduct investigations How far and in-depth do you go with your investigations What are current FDA "hot" buttons and trends Benchmarks and best practices for investigations
  • 133 Request Info

    Seminar on HIPAA Survival - All you need to Know

    This seminar will be addressing how practice/business managers (or compliance offers) need to get their HIPAA house in order before the imminent audits occur. It will also address major changes under the Omnibus Rule and any other applicable updates for 2017. Areas covered will be texting, email, encryption, medical messaging, voice data and risk factors as they relate to IT. The primary goal is to ensure everyone is well educated on what is myth and what is reality with this law, there is so much misleading information all over regarding the do's and don'ts with HIPAA - I want to add clarity for compliance officers I will uncover myths versus reality as it relates to this very enigmatic law based on over 1000 risk assessments performed as well as years of experience in dealing directly with the Office of Civil Rights HIPAA auditors.
  • 134 Request Info

    Supplier Management for Medical Device Manufacturers

    Supplier selection and management is one of the critical issues for medical device manufacturers. Suppliers provide materials and services to the device manufacturer, which means that they can be critical to performance and delivery of your device. 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. How well do you understand the requirements for supplier management? Could you pass a regulatory audit or inspection without any issues? This course delivers the tools, templates, and methods to help participants implement an effective and efficient supplier management program.
  • 135 Request Info

    Applying Principles of 21 CFR Part 820

    Overview: In this webinar, we apply the Theory of Lean documents and its corollary Theory of Lean Configuration to present a fresh approach to following 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: Managers, Supervisors, Directors, and Vice-Presidents R&D Manufacturing Engineering Design Assurance Quality Assurance Operations Document Control
  • 136 Request Info

    Understanding Risk Assessment of Proper Application

    Overview: Risk Assessment is a fundamental expectation in the regulated industries of pharmaceutical and medical devices. Performing risk assessments can be interpretive and needs to be well thought out in order to rationalize and substantiate conclusions drawn. Why should you Attend: The reason for attending would be to gain a perspective and understanding of the proper application of risk assessment. The proper practice of Risk Assessment is the current expectation of regulatory authorities. Areas Covered in the Session: The regulatory derivations of Risk Assessment The expectations of risk How to properly analyze and determine risk The fundamental equations necessary for risk assessment The tools of Risk Assessment and their definitions How to defend and assign proper risk Who Will Benefit: QA specialist Managers Engineers Operators
  • 137 Request Info

    Supplier Management Conference for Medical Device Manufacturing in Switzerland

    Overview: Supplier selection and management is one of the critical issues for medical device manufacturers. Suppliers provide materials and services to the device manufacturer, which means that they can be critical to performance and delivery of your device. Location: Zurich, Switzerland Date: April 10th & 11th, 2017 and Time: 9:00 AM to 6:00 PM Venue: Hilton Zurich Airport Address: Hohenbuhlstrasse 10, 8152 Opfikon-Glattbrugg, Switzerland Price: Price: $1,695.00 (Seminar Fee for One Delegate) Until February 28, Early Bird Price: $1,695.00 from March 01 to April 08, Regular Price: $1,895.00 Register for 5 attendees Price: $5,085.00 $8,475.00 You Save: $3,390.00 (40%)*
  • 138 Request Info

    Review process on Advertising & Promotional material compliance - 2017

    Overview: You will hear about the opportunities for input from regulatory agencies at critical stages and on key promotional materials and you will hear strategies for implementing review process and procedures to facilitate high compliance standards. Why should you Attend: This webinar will address issues of compliance in the creation of advertising and promotional materials and the appropriate internal assurances that compliance of materials is appropriately assessed, evaluated, and documented.
  • 139 Request Info

    FDA current recommendations on using electronic health records - 2017

    Overview: This webinar will discuss FDA's current recommendations on using electronic health records in prospective clinical investigations of human drugs, biologics, medical devices and combination product.
  • 140 Request Info

    Phase I GMPs clinical trials - 2017

    Overview: Early clinical trials are conducted to establish initial safety of a drug. The studies are generally in small number of healthy subjects and use lower doses of the drug product. Why should you Attend: Attend this conference so that you may understand differences between GMP requirements for early and later stage clinical development. Explore and discuss ways to develop and implement strategies for early GMPs for phase I clinical studies.