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Courses

  • 401 Request Info

    Software Risk Analysis Tools for Medical Devices and Risk Mitigation at San Diego

    Overview: The FDA recalls related to software performance are on the increase for at least five years at the time of this writing. Software failures were behind 24 percent of all the medical device recalls in 2011, according to data from the FDA. Similar to hardware, software also has hazards (any source of harm) and hazardous situations which transform a hazard into harm. We must identify hazards and identify what event can turn them into harm and write software specifications to prevent such combinations. The risk management tools such as FMEA (Failure Mode and Effects Analysis), FTA (Fault Tree Analysis) can help to mitigate software risks. These tools are covered in the Chapter 4. The mitigations from using the tools become the new requirements in the software specification
  • 402 Request Info

    Seminar on Compliance Software Solutions for Medical Devices at Singapore

    Course "Compliance Software Solutions for Medical Devices" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion. Overview: Software's level of complexity and use is expanding at exponential levels. Likewise the potential risks to health follow suit. Problems with software create a number of different hurdles. Software may be a standalone device, control a device's performance, make calculations, identify treatment options or begin to play a more active role in making clinical decisions regarding patient management and treatment. FDA's risk classification will gradually clarify how it intends to manage the health risks. Software use has become increasingly complicated with the expansion of software applications, for example: cybersecurity, interoperability, mobile medical "apps," home use and remote use.
  • 403 Request Info

    Seminar on The A to Z's of Microbial Control, Monitoring, Validation and Troubleshooting of Pharmaceutical Water Systems at Zurich, Switzerland

    Overview: This course is designed to provide a microbiology-focused education about all aspects of water systems and how biofilm manages to thrive there. Prior microbiological education or training, though a plus, is not a requirement because engineers and other non-biologists also need this training if they are involved with any aspect of water systems. The instructor will provide the necessary background needed to understand this very important subject matter. This understanding is essential to the proper design, validation, operation, monitoring, maintenance, troubleshooting, and excursion investigations of a high purity water system. Without this understanding, water system control consists of a set of rules that often don't work and can cause very costly system downtime or even product recalls, and leaves the user without a clue as to what went wrong or how to effectively fix it so it doesn't recur.
  • 404 Request Info

    The A to Z's of Microbial Control, Monitoring, Validation and Troubleshooting of Pharmaceutical Water Systems at Sydney, Australia

    Course "The A to Z's of Microbial Control, Monitoring, Validation and Troubleshooting of Pharmaceutical Water Systems " has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion. Overview: This course is designed to provide a microbiology-focused education about all aspects of water systems and how biofilm manages to thrive there. Prior microbiological education or training, though a plus, is not a requirement because engineers and other non-biologists also need this training if they are involved with any aspect of water systems. The instructor will provide the necessary background needed to understand this very important subject matter. This understanding is essential to the proper design, validation, operation, monitoring, maintenance, troubleshooting, and excursion investigations of a high purity water system.
  • 405 Request Info

    Production and Process Control: Building a Robust System for Medical Device Companies: 2-Day In-Person Seminar

    It does if you have the right controls in place - including documented instructions, environmental control, adequate equipment properly installed and maintained, production software that you trust, properly controlled test equipment, and validated processes - and your system implements both FDA QSR and ISO 13485:2003. In this two-day workshop, you will learn the essentials of production and process control. Beyond the essentials, the workshop provides practical methods to help you create a robust system that produces your devices and can withstand a rigorous FDA Inspection. Breakout sessions provide an opportunity to put the lessons into practice. Case studies, based on FDA Warning Letters and the Quality System Inspection Technique (QSIT), provide an opportunity to learn from the experience of other companies. Note: Use coupon code NB5SQH8N and get 10% off on registration, Valid till Dec 31st 2015.
  • 406 Request Info

    Human Factors and Design Controls for Medical Devices and Combination Products: 2-day In-person Seminar

    The course will give the participant the ability to formulate an QMS document and a thorough understanding of verification and validation procedures, The course will also give through guidance in development of Combination products both for the USA and European marketplace from a regulatory and manufacturing point of view. Emphasis will be placed on critical pathways, clinical development and regulatory approval. Who Will Benefit: Drug, device, diagnostics, and biologics regulatory, quality, and clinical professionals involved with combination product development and oversight Product stewards Business development executives involved in combination product strategic partnerships Note: Use coupon code 232082 and get 10% off on registration.
  • 407 Request Info

    ComplianceOnline Medical Device Summit - 2015

    Innovate novel ideas for advancements in medical device technologies without compromising their safety and effectiveness. This summit brings together some of the renowned R & D experts and technology innovators to share information regarding opportunities, obstacles, best practices and challenges in the development of the new devices. Attendees will get insight into device innovation trends and upcoming changes in the medical device regulations. Why you should attend this summit Future trends of Medical Device Regulation, Risk Management, UDI, recall complaint Management etc. Listen from FDA/CHRH Directors: What is critical to Quality Get update on FDA compliance Listen from Congressman Scott Peters on “Medical Device an inside state perspective” Note: Use coupon code 232082 and get 10% off on registration.
  • 408 Request Info

    Latest Requirements for Sponsors and Laboratories for Analyzing Clinical Trial Samples to Meet GCP/GCLP Internationally

    This webinar will help clinical laboratories, analyzing samples from clinical trials, understand the compliance requirements concerning ICH GCP for FDA and EMA compliance. Who Will Benefit: This webinar will provide critical assistance to FDA and EMA regulated companies currently carrying out or preparing to conduct clinical trials for pharmaceutical, biotechnology, and biologics products using clinical laboratories. It will also be applicable to personnel working in clinical laboratories. Clinical development managers and personnel Clinical research associates Clinical research archiving and document management personnel Instructor Profile: Dr. Laura Brown, PhD, MBA, Diploma Clinical Sciences, is an independent QA and training consultant in the pharmaceutical industry. Note: Use coupon code 232082 and get 10% off on registration.
  • 409 Request Info

    Best Practices for Medical Device Reporting (MDR), Recall, Reports of Corrections and Removals

    This webinar will discuss requirements and compliance under the applicable FDA regulations for medical device reporting (MDR), recall and reports of corrections and removals in the US. Who Will Benefit: This webinar will be valuable for anyone in global medical device industry including, but not limited to, those working on drugs, biologics and in vitro diagnostic devices who are involved in the processes of adverse event reporting, recall, reports of corrections and removals, complaint handling and regulatory compliance. Instructor Profile: Dr. David Lim, president and principal of Regulatory Doctor, obtained his Ph.D. in biological sciences at the University of Missouri-Columbia and published his thesis research in the prestigious journal “Science.” Note: Use coupon code 232082 and get 10% off on registration.
  • 410 Request Info

    Creating a Global Regulatory Plan

    This regulatory training will help attendees understand key benefits for implementing and maintaining an effective global regulatory plan. Who Will Benefit: This webinar will provide valuable assistance to following personnel: Regulatory managers Project managers Product development managers Marketing managers Instructor Profile: Cheryl Wagoner, has 20 years of experience in quality assurance, and regulatory affairs. Ms. Wagoner currently is the Principal Consultant/Owner of Wagoner Consulting LLC, where she provides consulting services to medical device and pharmaceutical companies. Previously, she has held various positions in Quality, Regulatory, Clinical and Compliance in the medical device and pharmaceutical industries. Note: Use coupon code 232082 and get 10% off on registration.
  • 411 Request Info

    CE Mark - Required to Sell Medical Devices in the EU

    This webinar on selling medical devices in the European Union (EU) will immensely benefit companies wishing to penetrate the EU market for medical devices or sharpen their skills. Who will Benefit: Companies wishing to penetrate the EU market for medical devices or sharpen their skills will receive practical guidance on achieving the CE mark. Employees who will benefit include: Quality & Regulatory Professionals Manufacturing & Design Engineers Instructor Profile: John Chapman, BS, MBA, RAC has over 40 years’ medical device regulatory experience and over 20 years’ experience with the European Union’s medical device directive, 93/42/EEC. Note: Use coupon code 232082 and get 10% off on registration.
  • 412 Request Info

    Supplier Quality Agreements - Essential for Suppliers of Many Outsourced Processes

    This webinar will discuss in detail the use of the Global Harmonization Task Forces (GHTF) and Notified Body Operations Group (NBOG) supplier guidance documents to create QA agreements. Who Will Benefit: This webinar will provide valuable assistance to all personnel in: Quality Management Regulatory Affairs Supply-chain Management Supplier Engineering Instructor Profile: Betty Lane, has over 30 years’ experience in medical device quality assurance and regulatory affairs. Note: Use coupon code 232082 and get 10% off on registration.
  • 413 Request Info

    Failure Mode and Effects Analysis for Design Improvement and Design Control

    In this failure mode and effects analysis training, attendees will learn how to design medical devices that enhance reliability, durability, safety, and serviceability. Who Will Benefit: This course is designed for all technical employees. This is particularly important for all managers because 85% device defects are said to be the result of poor management practices. The following personnel will benefit from the course: Senior managers Quality assurance supervisors Design engineers R&D engineers Instructor Profile: Dev Raheja, MS,CSP, author of the books Preventing Medical Device Recalls and Safer Hospital Care, is an international risk management, patient safety and quality assurance consultant for medical device, healthcare and aerospace industry for over 25 years. Note: Use coupon code 232082 and get 10% off on registration.
  • 414 Request Info

    Understanding the Mobile Medical Applications Guidance

    This medical device webinar will discuss the FDA guidance on Mobile Medical Applications and provide clarification on the primary points of the guidance. Who Will Benefit: This webinar will provide valuable assistance to following personnel in the medical device industry: Regulatory affairs Project managers Staff involved with regulatory filings Product Development managers Instructor Profile: Cheryl Wagoner, has 20 years of experience in quality assurance, and regulatory affairs. She currently is the Principal Consultant/Owner of Wagoner Consulting LLC, where she provides consulting services to medical device and pharmaceutical companies. Note: Use coupon code 232082 and get 10% off on registration.
  • 415 Request Info

    Verification vs. Validation in Regulated Industries

    This webinar on verification vs. validation will help you to understand the differences between, and benefits of, verification and validation in both design and process operations in regulated industries. Who Will Benefit: Companies wishing to understand the risks and complications involved with the application of sound verification and validation principles will gain a better understanding of the differences and benefits. Employees who will benefit include: Quality & Regulatory Professionals Manufacturing & Design Engineers Marketing Product Managers Corporate & Operations Executives Instructor Profile: John Chapman, BS, MBA, RAC has over 35 years medical device regulatory experience and over 15 years experience with the European Union’s medical device directive, 93/42/EEC. Note: Use coupon code 232082 and get 10% off on registration.
  • 416 Request Info

    Quality Assurance at the (Clinical Research) Site: How to Develop a Manageable Plan

    This clinical compliance training will help attendees understand how they can develop and implement a Quality Assurance (QA) program at their clinical research site that ensures the staff are properly trained and that the research is carried out in accordance with regulatory expectations. Who Will Benefit: This webinar will provide valuable assistance to following personnel: Experienced Clinical Research Coordinators Experienced Principal Investigators Experienced Clinical Research Associates (Monitors) Instructor Profile: Jennifer Holcomb, MA, CCRC, is a clinical research professional with over 20 years of experience in the field. Note: Use coupon code NB5SQH8N and get 10% off on registration.
  • 417 Request Info

    Navigating the New FDA Draft Guidance on ISO 10993: Biological Evaluation of Medical Devices

    The webinar will focus on the amendments made to the Blue Book Memorandum #G95-1 Use of International Standards ISO-10993, “Biological Evaluation of Medical Devices Part 1: Evaluation and Testing.” Who Will Benefit: This webinar will benefit the following personnel in the medical device industry: Regulatory managers Project managers Staff involved with regulatory filings Product development managers Instructor Profile: Cheryl Wagoner, has 20 years of experience in quality assurance and regulatory affairs. She currently is the principal consultant/owner of Wagoner Consulting LLC, where she provides consulting services to medical device and pharmaceutical companies. Previously, she has held various positions in quality, regulatory, clinical and compliance in the medical device and pharmaceutical industries. Note: Use coupon code 232082 and get 10% off on registration.
  • 418 Request Info

    Creating a Good Design History File (DHF) for Audit Success

    This DHF regulatory compliance training will discuss the structure of a good Design History File, elements to look for when auditing a DHF and how to address issues. Why Should You Attend: A Design History File (DHF) is a requirement of QSR 21 CFR Part 820. It is a certainty that in an audit from a regulatory body, information from the DHF will need to be provided. Who Will Benefit: This webinar will provide valuable assistance to medical device companies in managing their Design History Files. The employees who will benefit include: R&D Engineers Quality Engineers Regulatory Affairs Instructor Profile: Mercedes Massana, is the founder and CEO of MDM Engineering Consultants, a consulting firm that provides engineering and quality consulting services in the medical device, biotechnology, and pharmaceutical industries. Note: Use coupon code NB5SQH8N and get 10% off on registration.
  • 419 Request Info

    Seminar on Validation and 21 CFR 11 Compliance of Computer Systems: Intermediate to Advance

    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
  • 420 Request Info

    Problem Solving and Root Cause Analysis - the Key to an Effective CAPA System

    This program is designed to provide participants with: • Understanding and developing an effective Corrective and Preventive Action System • An understanding of a structured problem solving process • Tools and techniques to perform root causes analyses • The use of facts and data to eliminate the use and identification of ineffective solutions. An 8-Step Process is presented during the program, consisting of: 1. Identify the Problem 2. Identify the Team 3. Contain the Problem 4. Describe the Problem 5. Identify Possible Causes 6. Identify Root Cause 7. Implement Corrective/Preventive Action 8. Measure and Monitor Results