Medical Devices

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Courses

  • 1 Request Info

    Updated CE Marking Process & ISO 13485:2016 Expectations

    After completion of this course, attendees will have enhanced knowledge of the ever-changing landscape of Medical Device Regulation in the EU, Also The content of this course is designed to simplify the understanding of requirements and to provide attendees with the latest insight on how changes are being viewed and implemented by companies marketing products in the EU.
  • 2 Request Info

    Preparing for an FDA Inspection - What you Need to Know

    In this webinar you will learn how to manage inspections efficiently and effectively, Also you will learn how to present information about your quality system in the most competent and professional manner, This webinar can help you prepare a strategy and detailed plans to more successfully prepare for, manage, and respond to an FDA or Notified Body Inspection.
  • 3 Request Info

    Biocompatibility Testing for Medical Devices : One and a Half Day In-Person Seminar

    The medical device field is one of the most heavily regulated industries, for obvious reasons. Medical devices are an important tool in efforts to improve patient care and treatment outcomes. Learn how to achieve more successful biocompatibility testing outcomes by attending this seminar. Note: Use coupon code < REFERRAL10 > and get 10% off on registration.
  • 4 Request Info

    Effective Records Management & Document Control for Medical Devices

    Overview The document management system for medical device industry should help companies have control over critical activities such as: Establishing best practice SOP, Deviation, CAPA, Change Controls, Complaint and Audit processes Conducting Risk Assessment, Root Cause Analysis and Impact Assessment where appropriate Creating Action Plans, and verifying their effectiveness Improving efficiencies over the QMS tasks Reducing the risks of manual error
  • 5 Request Info

    How to Prepare for a Robot-Automated and AI-Enhanced Future in Accounting

    Overview A recent MIT-Boston Consulting study of over 3,000 companies found that 80% of them believed AI (artificial intelligence) would give them a competitive advantage. What's more, we are already seeing the use of AI and RPA (robotic process automation) creeping into the business world, and more specifically into various accounting functions. This is one change that will radically impact many white-collar jobs. And that change will happen in the next few years, not ten or twenty years from now.
  • 6 Request Info

    Packaging and Labeling in the Pharmaceutical Supply Chain

    Overview: Packaging and Labeling form a bridge between the conception of a product and its realization and distribution, and consequently occupy a critical position in the success or failure of any pharmaceutical product launch or revision. Decision-makers need at least a cursory knowledge of potential pitfalls to create contingencies, as it is easier and more cost-effective to change things earlier in process than later.
  • 7 Request Info

    Validation Sampling Plans for Process Validation

    Overview: This course is designed to help you select sampling sizes and acceptance criteria for one-time studies like process validation, design verification, component qualifications and CAPA effectiveness checks including: How to link risk with the confidence statements associated with the sampling plans Identify a variety of sampling plans, that all make the desired confidence statements
  • 8 Request Info

    ISO/IEC 17025:2017 Section 7 - Process Requirements and Section 8

    Overview: How does the new standard impact laboratories that are already accredited and how do you ensure staff adherence and ongoing compliance to minimize corrective actions arising from accreditation audits?
  • 9 Request Info

    6-Hour Virtual Seminar - The New EU Medical Device Regulation

    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.
  • 10 Request Info

    Good Laboratory Practices (GLPs) Comparing and Contrasting GMP

    The objective of this webinar is to compare and contrast between Good Laboratory Practices and Good Manufacturing practices. Why you should attend Good Laboratory Practices (GLPs), 21 CFR part 58 are not set of guidelines but they are regulations for conducting nonclinical laboratory studies that support or are intended to support applications for research or marketing permits for products such as food and color additives, human and animal drugs, medical devices for human use, biological products and electronic products that are regulated by the FDA.
  • 11 Request Info

    Dealing with ADHD in the Office

    Overview A person working machinery gets distracted can end up in a danger situation. A person staring out of their office window can end up wasting hours in a day and causing their productivity to slide. Office meetings can be disrupted by someone blurting out an answer before the question is fully out. Making meeting run on and wasting time Managing a person's attention in a work environment raises productivity, enhances office moral and increase performance on multiple levels.
  • 12 Request Info

    3-Hour Virtual Seminar on CAPA for Medical Devices

    Overview: CAPA is the foundation of an effective Quality Management System. Yet, many companies suffer from Death by CAPA - a slow, bureaucratic, and ineffective CAPA process. Not only do they fail to achieve necessary improvements, they waste precious time and resources. This 3-hour webinar will help you establish an efficient and effective CAPA (Corrective and Preventive Action) process leading to improved quality and compliance for your company. Learn how to avoid common problems and establish an efficient and effective CAPA process leading to improved quality and compliance for your company.
  • 13 Request Info

    Architect and Implement Solution 2019

    Overview: Learn to properly prepare for an impact to the business for any organization. We will cover how to identify, analyze and document the events and environmental surroundings that can adversely affect the organization. You will learn how to both prepare and review the continuity planning program. Areas such as IT Outsourcing and other risks will be covered. It is critical to assess the IT and Information Security risks and the effectiveness of the institution's risk management processes as they relate to the security measures.
  • 14 Request Info

    Webinar on Medical Device Complaints & CAPA

    Attend this webinar to learn the most important areas of medical device safety and how complaint handling and CAPA process is used during FDA inspections. 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/Medical-Device-Complaints-CAPA-506097/APRIL-2019-ES-TRAININGREGISTRY
  • 15 Request Info

    Strategies to Prevent Manufacture and Distribution of Substandard Medications

    Substandard product can exist even if the product itself is manufactured according to quality standards. Muhammad H. Zaman, in his book Bitter Pills, recalls his visit to a warehouse in Ghana that had no climate control, with temperatures in the warehouse reaching 95 degrees Fahrenheit. Recently, Allergan's Taytulla birth control products were recalled due to the packaging of active tablets and inert tablets in the wrong order, potentially leading to patients likewise taking the tablets in the wrong order and not obtaining the desired result. Allergan stated, "As a result of this packaging error, oral contraceptive capsules that are taken out of sequence may place the user at risk for contraceptive failure and unintended pregnancy."
  • 16 Request Info

    Reprocessing Reusable Medical Devices - Cleaning and Labeling Requirements

    Any firm reprocessing another manufacturer's medical device becomes the legal manufacturer with all the responsibilities for compliance, especially sterility. Failure to prove sterility is almost certainly a cause for either voluntary recall or FDA mandated recall. The same is true if you are reprocessing your own medical device. If intended to be re-sterilized by the user facility, cleaning and sterilization instructions must be precise and validated. Much attention has been paid to the regulatory requirements of reprocessing single use devices.
  • 17 Request Info

    Webinar on Cleaning Validations Using Extraction Techniques

    This webinar will provide valuable guidance on how to use extraction techniques to validate the cleanliness of a device. 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/Cleaning-Validations-Using-Extraction-Techniques-504912/MARCH-2019-ES-TRAININGREGISTRY
  • 18 Request Info

    Webinar on Good Documentation Practices and FDA Compliance

    Learn how to create and maintain good documentation that meets FDA computer system validation and compliance standard. Register for this webinar 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/Good-Documentation-Practices-to-Support-FDA-Computer-System-Validation-and-Compliance-502210/MARCH-2019-ES-TRAININGREGISTRY
  • 19 Request Info

    Webinar on 21 CFR Part 11 - Electronic Record and Signature Validation

    This session will provide you information with procedures for controlling electronic signatures and electronic records and how 21 CFR Part 11 is connected with this area. 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/21-CFR-Part-11-Electronic-Record-and-Signature-Validation-509394/MARCH-2019-ES-TRAININGREGISTRY
  • 20 Request Info

    Webinar on FDA Inspection: From SOP to 483

    This session will provide you guidance on how to prepare, behave and respond to an FDA inspection. 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/FDA-Inspection-From-SOP-to-483-503330/MARCH-2019-ES-TRAININGREGISTRY