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Courses

  • 101 Request Info

    Los Angeles Seminar on Designing and Monitoring Approvable Medical Device (cardiovascular) Protocols

    This seminar should be attended to ensure the proper compliance and development of traditional and new cardiovascular medical devices. Failure to attend could result in poorly managed clinical trials, wasted financial resources and liability based law suits. The development of well-designed clinical trials and rigorous monitoring is required. From the literature review to the last appendix, a protocol is THE tool required to be approved by IRBs, FDA and the sponsor/developer of the device. Monitoring according to GCP guidelines is required to determine evaluable patients. The more mistakes that are made the higher the cost. It takes 10 times as much time and money to fix mistakes/errors and a misunderstanding as it does to do it right from the beginning. It requires significant training, resources and extraordinary diligence, planning and execution to design a cardiovascular device protocol and successfully monitor it.
  • 102 Request Info

    Boston Conference on FDA Device Software Regulation

    The growth of the medical software industry outpaces how FDA's regulatory process is designed. How can you anticipate and defend against the malicious remote hacking and shut down of an insulin infusion pump? In some instances clinicians have weighed the risk of software failure against the benefits of using a device at all. You need to understand and apply the current provisions that NIST has put forth in recent reports FDA will integrate them into its regulatory oversight. Device software is often used in conjunction with other software-based devices, but their interoperability was never anticipated. Can one software program defeat the performance capability or back up safety features of another software program? When interoperability surface, which software manufacturer takes the lead to solve the problem and deal with proprietary software issues?
  • 103 Request Info

    Baltimore Seminar on Medical Device Complaint Handling

    In this two-day workshop you will understand all the processes and elements in a Quality Management System (QMS) that come to bear on effective Complaint Management. It starts with the definition of a complaint in FDA's Quality System Regulation (QSR) and ISO 13485:2003. (The complaint definitions are not the same.) In these systems a complaint has a specific technical meaning that is significantly different from the colloquial meaning.
  • 104 Request Info

    Medical Device Complaint Handling

    In this two-day workshop you will understand all the processes and elements in a Quality Management System (QMS) that come to bear on effective Complaint Management. It starts with the definition of a complaint in FDA's Quality System Regulation (QSR) and ISO 13485:2003. (The complaint definitions are not the same.) In these systems a complaint has a specific technical meaning that is significantly different from the colloquial meaning.
  • 105 Request Info

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

    All life science businesses are required to maintain their Quality Management System (QMS) processes in a state of control, via controlled documents and objective evidence in the form of records. Medical device manufacturing plants, required to follow 21 CFR Part 820, have the additional responsibility to ensure that each and every step of the manufacturing process is controlled by work instructions, SOPs, set-up instructions, equipment maintenance, and support functions, and that evidence of this work is maintained by controlled records.
  • 106 Request Info

    Webinar on Better Alternatives to AQL Sampling Plans for Risk Management in Incoming QC

    The pros and cons of the 2 most widely used sampling plans (ANSI Z1.4, and Squeglia's C=0) are examined in detail, focusing especially on the weaknesses of such plans in regards to meeting regulatory requirements. Real-world examples are provided for how using such sampling plans leads to production of non-conforming product. The advantages of "confidence/reliability" calculations are explained. Such calculations are demonstrated for Attribute data (pass/fail, yes/no data) as well as for variables data (i.e., measurements). If variables data is "Normally distributed" the calculations are extremely simple. The webinar explains how to handle "non-Normal" data, and provides the methods, formulas, and tools to handle non-normality.
  • 107 Request Info

    Webinar on Drug Master Files: Understanding and Meeting your Regulatory and Processing Responsibilities

    This combined Quality Agreement and DMF (Drug Master Files) training will discuss the advantages for suppliers and drug product manufacturers developing these arrangements together. This combined Quality Agreement and DMF (Drug Master Files) training will discuss the advantages for suppliers and drug product manufacturers developing these arrangements together. Over time, there have been several misunderstandings between supplier / contractors and pharmaceutical / biologic finished product manufacturers.
  • 108 Request Info

    Webinar on 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.
  • 109 Request Info

    Webinar on Sample Size and Statistical Rationale for Medical Device Packaging Validations

    Compliance to ISO 11607, Parts 1 and 2 require that Packaging Validations include the development of a statistical rationale to support the testing conclusions of sterile barrier systems and packaging processes. Learn the basics of a process for developing a validation statistical rationale for packaging sterile barrier systems and processes.
  • 110 Request Info

    FDA Device Software Regulation

    GlobalCompliancePanel Refer a Friend Program: Any Customer to 3 Referrals "Can Participate 2 Days Seminar for free of Cost The increasing sophistication and venue for use create new software design validation considerations. In many instances, validation is limited to the immediate use of the software rather than its environment of use, its performance with other software programs and software hacking. When software causes a problem, fixing the malfunction or "bug" may be more difficult as software becomes more sophisticated, customized by users and placed in a network system. In these kinds of circumstances, it is difficult to decide who is responsible for managing and fixing the software problems. This becomes a major regulatory headache for FDA and generates business-to-business conflicts. When firms are designing and marketing software, they should be mindful the unknowns that lurk in the future of software regulated as a device by FDA.
  • 111 Request Info

    Applying U.S. FDA Laws and Regulations to Each Phase of Total Product Life Cycle (TPLC)

    This workshop style training course is supported by comprehensive knowledge of U.S. FDA laws and regulations and 30 year of extensive experience working within in the U.S. FDA regulated industries. In these 2 days, the following essential topics will be covered: • Total Product Life Cycle and Your Medical Device • An Overview of U.S. FDA Medical Device Regulation • Regulations for Design and Product Development • Premarket Notification - 510(k) and Premarket Approval (PMA) • Regulations for Production & Process Control • Readiness for FDA Facility Inspection GlobalCompliancePanel Refer a Friend Program: Any Customer to 3 Referrals "Can Participate 2 Days Seminar for free of Cost
  • 112 Request Info

    How FDA Trains Its Investigators to Review Sub-Systems for State of Compliance

    The Seminar will provide all details relevant to Pre and Post-Inspectional activities, tactics, strategies and is a must for those who have never gone through an FDA inspection and as a "refresh" for those who have to ensure your "state-of-readiness" and being prepared. GlobalCompliancePanel Refer a Friend Program: Any Customer to 3 Referrals "Can Participate 2 Days Seminar for free of Cost
  • 113 Request Info

    Internal Auditing for the Medical Device Industry

    Overview: This course provides an overview of internal auditing requirements and techniques for medical device companies as a method for risk management and quality improvement. The course will cover auditing requirements, audit planning, preparation, knowledge, auditor skills, interviews, documents and records review, objective evidence, audit report writing and corrective action. GlobalCompliancePanel Refer a Friend Program: Any Customer to 3 Referrals "Can Participate 2 Days Seminar for free of Cost
  • 114 Request Info

    Seminar on Preparing Premarket Submissions that secures U.S. FDA Clearances/Approvals: 510(k)/Pre-IDE/IDE and PMA

    This workshop style training course is designed based on 30 year of regulatory affairs experience in preparing more than 150 successful U.S. FDA submissions for major medical device companies. This 2 days training seminar will walk you through building process of a reader’s friendly but resounding premarket submission and also give you tips and suggestions on how to work effectively with the U.S. FDA officials during review and approval process of your submission. GlobalCompliancePanel Refer a Friend Program: Any Customer to 3 Referrals "Can Participate 2 Days Seminar for free of Cost Quick Contact: NetZealous DBA as GlobalCompliancePanel Phone: 1-800-447-9407 Fax: 302-288-6884 Email: support@globalcompliancepanel.com Website: http://www.globalcompliancepanel.com/ Registration Link - http://bit.ly/preparing-premarket-submissions-Boston
  • 115 Request Info

    Seminar on Key Factors to Write an Effective Standard Operating Procedure (SOP) and Work Instructions (WIs)

    This session will address recent enforcement actions for SOP related violations but no surprise. Most of our enforcement actions are documentation related, i.e., SOP or other procedural documents. We will review examples from warning letters and then review the good and bad SOPs and templates. Standard operating procedures work best when they are designed to achieve specific results. Decide what business goals will be achieved through better management with SOPs and how those goals will be measured. The lack of or inadequate standard operating procedures (SOPs) continues to dominate the FDA's inspectional observations. Following SOPs are much more important than writing them. Even the best written SOPs are useless if they are not followed. GlobalCompliancePanel Refer a Friend Program: Any Customer to 3 Referrals "Can Participate 2 Days Seminar for free of Cost
  • 116 Request Info

    Conference on Validation and Part 11 Compliance of Computer Systems and Data

    Computer Systems Validation (CSV) also known as Software Validation is all-pervasive in the Life Sciences Industry. It is a requirement of all the predicate rules, as well as 21 CFR 11 and Annex 11. However, unless one knows how to implement CSV, it is often very hard to detect the requirement for CSV, and very hard to determine what needs to be done, to meet domestic and / or international regulations or business continuity requirements. In addition, the FDA has stepped up 21 CFR 11 inspections that include CSV. This course will build on the Validation and 21 CFR 11 Compliance Basic Course, to give hands on experience on executing on the computer systems validation of a system, and to discuss related activities such as Validation Master Plan, Infrastructure Qualification, Project Management for Validation and Validation of Test Tools GlobalCompliancePanel Refer a Friend Program: Any Customer to 3 Referrals "Can Participate 2 Days Seminar for free of Cost
  • 117 Request Info

    Seminar on Best Practices for Safety Reporting in Clinical Trials for Drugs, Biologics and Medical Devices

    The Food and Drug Administration's Center for Drug Evaluation Research, Center for Biologics Evaluation Research and Center for Devices and Radiological Health are responsible for the approval of drug products, biologics and medical devices industries. This seminar begins with outlining the structural role of the FDA and a brief introduction to the Food, Drug and Cosmetic Act (the ACT) and how the FDA uses it to enforce the regulatory requirements during the drug, biologics and medical device approval process. This course is designed for people tasked with developing drug products, biologics and medical devices; and responsible for overseeing a company's clinical development program and regulatory strategies. GlobalCompliancePanel Refer a Friend Program: Any Customer to 3 Referrals "Can Participate 2 Days Seminar for free of Cost
  • 118 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.
  • 119 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.
  • 120 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.