Medical Devices

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  • 81 Request Info

    New EU Medical Device Regulation | Updated Regulation 2018

    In 2012, the Commission adopted a package of measures on innovation in health. The package consisted of a Communication and two regulation proposals to revise existing legislation on general medical devices and in vitro diagnostic medical devices. In particular, the Directives on active implantable medical devices (90/385/EEC) and on medical devices (93/42/EEC) are intended to be replaced by a Regulation on medical devices, while the Directive on in-vitro diagnostic medical devices (98/79/EC) is intended to be replaced by a Regulation on the same subject.The revisions therefore affected all kinds of medical devices including in vitro diagnostic medical devices, from home-use items like sticking plasters, pregnancy tests and contact lenses, to X-ray machines, pacemakers, breast implants, hip replacements and HIV blood tests.
  • 82 Request Info

    Training for Small Healthcare Providers | HIPAA Seminar 2018

    Being in compliance with HIPAA involves not only ensuring you provide the appropriate patient rights and controls on your uses and disclosures of protected health information, but you also have the proper policies and procedures in place. If audited or the subject of a compliance review you will be required to show the government you have all the necessary documentation in place for safeguarding patient Protected Health Information and indicate how you addressed all required security safeguards. This starts with the fundamentals of a HIPAA compliance program.
  • 83 Request Info

    FDA 21 CFR Part 11 Compliance | Validation Seminar 2018

    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.
  • 84 Request Info

    Webinar on How to Prepare for and Host a FDA Inspection and Avoid 483's

    In this webinar you will learn about the types of FDA inspections, necessary preparations such as assigning dedicated personnel to specific tasks for the inspection, facility requirements to support the inspection, the value of mock audits, how company personnel should conduct themselves during the inspection, how the inspection will unfold and how to respond to 483's. Price:$250.00. Contact info : OnlineCompliancePanel Phn. no. +1-510-857-5896 Fax-+1-510-509-9659 Event link
  • 85 Request Info

    Webinar on Medical Device Single Audit Program (MDSAP) - All You Need To Know

    What is MDSAP and where is it going? Will it eventually touch my business anywhere in the world? MDSAP is creating a playing field among regulatory bodies around the world. That playing field consists of the 6 critical regulatory bodies that are participating in the development of future considerations for an equivalent and reciprocal set of conscript elements of compliance to GMP conditions of operation. Price:$250.00. Contact info : OnlineCompliancePanel Phn. no. +1-510-857-5896 Fax-+1-510-509-9659 Event link
  • 86 Request Info

    Webinar on Developing an Effective Risk Management Plan for Medical Devices

    This presentation gives you the essential information to write a successful Risk Management Plan. Don't skip required items or add additional, but unnecessary information. If the item doesn't apply, so why. Don't include extraneous information such as market size and share; they are not relevant. The Risk Management Plan is key for an efficacious project that helps to ensure your device is safe and meets the regulatory requirements.Price:$250.00. Contact info : OnlineCompliancePanel Phn. no. +1-510-857-5896 Fax-+1-510-509-9659 Event link
  • 87 Request Info

    How to Choose Which One to Implement

    Overview: This webinar will review the benefits of implementing a QMS, discuss the applicability of each standard to different types of organizations, and go on to explain the similarities, key differences, scope, and application of these standards to an organization.
  • 88 Request Info

    Discussion on Raw Material Methods and Specifications

    Overview: When establishing specifications for compendia items, it should be noted that there may be specific attributes of the inactive ingredient that are important for the company's product and/or manufacturing process but that are not identified as part of the compendia specifications. Thus appropriate testing and proper evaluations of all product ingredients can be established via the use of alternate methods to obtain true picture of ingredients.
  • 89 Request Info

    Webinar on What is Office 365 and How can it Benefit me?

    In this session you will discover what Office 365 is and how it is used. You will find out how it is used in an organization and also as an individual. We will look at what is included, how it works online and offline. How we can share and generally collaborate. Price:$200.00. Contact info : OnlineCompliancePanel Phn. no. +1-510-857-5896 Fax-+1-510-509-9659 Event link
  • 90 Request Info

    Webinar on Transform from Operations Laggard to Operations Leader

    Attendees will leave this meeting with a clear idea of where they stand, where they could be, and the justification for moving from operations laggard to leader. They also will hear many success stories, as well as the challenges involved in making the transition. This webinar is intended to answer the questions that lead to insights, justification, transition, and dramatic success. Price:$200.00. Contact info : OnlineCompliancePanel Phn. no. +1-510-857-5896 Fax-+1-510-509-9659 Event link
  • 91 Request Info

    Webinar on Excel Power Query: The Powerful 'Get & Transform' Tool for Importing and Manipulating Data

    Do you work with "Big Data"? Do you import and manipulate large datasets in Excel? If so you'll already be familiar with the limitations of Excel. Power Query, (known as Get and Transform in Excel 2016) is designed to get you past these limitations, allowing you to import and work with 1-million-plus-row datasets from virtually any source. Price:$200.00. Contact info : OnlineCompliancePanel Phn. no. +1-510-857-5896 Fax-+1-510-509-9659 Event link
  • 92 Request Info

    Webinar on Discharge Planning Worksheet and Standards: Ensuring Compliance with the 2018 CMS Hospital CoPs and Proposed Changes

    This program will discuss the final surveyor worksheet for assessing compliance with the CMS hospital Conditions of Participation (CoPs) for discharge planning. This worksheet is used by State and Federal surveyors on all survey activity in hospitals assessing compliance with the discharge planning standards. The worksheet will be revised to reflect the proposed discharged planning guidelines when finalized. This webinar will discuss what has changed based on the IMPACT Act and the proposed discharge planning standards which are significant. Price:$200.00. Contact info : OnlineCompliancePanel Phn. no. +1-510-857-5896 Fax-+1-510-509-9659 Event link
  • 93 Request Info

    Webinar on 21 CFR 111 GMP Dietary Supplement Laboratory

    Dietary supplements are governed by 21 CFR 111 in production, testing, storage and distribution. Although dietary supplements are not pharmaceuticals they are still subject to stringent regulations designed to insure safety and consistency of the products. This webinar will address multiple subparts of 21 CFR 111 specifically discussing laboratory facilities, equipment/instrumentation and process controls. Price:$250.00. Contact info : OnlineCompliancePanel Phn. no. +1-510-857-5896 Fax-+1-510-509-9659 Event link
  • 94 Request Info

    Recent Updates of FDA 21 CFR 11 Add-On Inspections

    Overview: This presentation will cover the scope, status and results of the surveillance inspections and what they may mean for the future of 21 CFR Part 11. This will enable you to determine whether your company is subject to the most common violations so you can take action to have a better inspection outcome. Why should you Attend: In December 2010 the FDA changed the way it does audits to include 21 CFR 11 add-on inspections. Very little is known about this, yet the FDA has already issued citations on the subject.
  • 95 Request Info

    Investigating Sterility Test Failures

    Sterility testing is widely used in both the medical device and pharmaceutical industries. The pharmacopeia test is the official procedure for testing the sterility of pharmaceutical products. Despite its importance and its widespread use, many people are not aware of the limitations of the sterility test and are unsure how to proceed when a failure investigation occurs. Price:$250.00. Contact info : OnlineCompliancePanel Phn. no. +1-510-857-5896 Fax-+1-510-509-9659 Event link
  • 96 Request Info

    Webinar on Intelligent Approach to Risk-Based Monitoring to Improve Clinical Trial QualityROs and sponsors serious about driving clinical trial qualit

    ROs and sponsors serious about driving clinical trial quality, efficiency, and oversight, are aware of the FDA guidance: "A Risk-Based Approach to Monitoring." From a practical level, how do you start your program and gain the full advantages of RBM? This course will provide opportunities to practice the necessary skills to apply a risk based approach to monitoring activities. This webinar will help you how to ensure that your data and supporting documentation are in the appropriate format to comply with regulatory authority inspection. Risk based monitoring can contribute to better oversight and more efficient use of resources of clinical studies. Price:$250.00. Contact info : OnlineCompliancePanel Phn. no. +1-510-857-5896 Fax-+1-510-509-9659 Event link
  • 97 Request Info

    Webinar on How to Break Into Brazilian Market - A Regulatory Overview for Cosmetics and Personal Hygiene Products

    This webinar will provide an understanding of the Brazilian market regulatory rules and requirements for cosmetics and personal hygiene products. Attendees will acquire valuable information on the hottest topics allowing them to plan and enter the Brazilian market on a timely and legal manner. Price:$200.00. Contact info : OnlineCompliancePanel Phn. no. +1-510-857-5896 Fax-+1-510-509-9659 Event link
  • 98 Request Info

    Why Capturing Justifications in Change Control

    Overview: It is easy to document what process has been performed, what has been investigated or changed or why something is a risk, but the difficult part is knowing how to explain or justify why it should be done or why a product should be released or rejected as a result. Areas Covered in the Session: Determine alternatives or options to the proposed solution Analyze costs, benefits, impacts, and risks of the proposed solution Validate the solution, assess product impact to the market
  • 99 Request Info

    Act for Transportation and Logistics Professionals

    Overview: The FSMA is paradigm shift that moves the focus from food inspections to preventative measures and process compliance. Why should you Attend: Specific provisions of the FSMA that impacts transportation and 3rd party logistics providers Sanitary transportation best practices To develop a food safety plan that identifies potential risks, preventative controls and ongoing monitoring New rules that govern food importers and exporters Areas Covered in the Session: How the trend toward transparency and widespread supply chain knowledge (among consumers) will impact sourcing decisions Why sustainable supply chains will become more mainstream, especially among luxury buyers and millennials Why low cost country sourcing will be replaced by production closer to consumers
  • 100 Request Info

    How using such Sampling Plans Leads to Production

    Overview: 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.