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Courses

  • 1 Request Info

    21 CFR Part 11 - Compliance for Electronic Records and Signatures

    Overview: This Webinar will explain what 21 CFR Part 11 is, why it is important to FDA regulated companies and how conformance to Part 11 differs from just having good IT security. Procedures for controlling electronic signatures and electronic records as described in the FDA Guidance will be explained. FDA regulated companies want to transition to electronic records for economy and efficiency. FDA, because of its concern for patient safety, wants to prevent electronic records from being compromised with possible resulting harm to the patient. FDA has set up regulations that address both data security and patient safety. We will show how 21 CFR part 11 considers both.
  • 2 Request Info

    21 CFR Part 11 compliance for software validation and SaaS/Cloud Seminar 2018

    • Finally, the instructor reviews recent FDA inspection trends and discusses how to streamline document authoring, revision, review, and approval. • This course benefits anyone that uses computer systems to perform their job functions and is ideal for regulatory, clinical, and IT professionals working in the health care, clinical trial, biopharmaceutical, and medical device sectors. It is essential for software vendors, auditors, and quality staff involved in GxP applications.
  • 3 Request Info

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

    This quality system regulation training will explain how to apply the theory of lean documents and its corollary theory of lean configuration to present a fresh approach to complying with 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: This webinar will provide valuable assistance to Managers, Supervisors, Directors, and Vice-Presidents in the areas of: R&D Manufacturing Engineering Design Assurance Instructor Profile: Jose Mora, is a Principal Consultant specializing in Manufacturing Engineering and Quality Systems. Use coupon code 232082 and get 10% off on registration.
  • 4 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.
  • 5 Request Info

    3rd Annual ComplianceOnline Medical Device Summit 2017

    Why you should attend this summit Future trends of Medical Device Regulation, Risk Management, UDI, recall complaint Management etc. Listen from FDA/CDRH Directors: What is critical to Quality Get update on FDA compliance Learn more about Medical Device Single Audit Program (MDSAP) and Other Third Party Programs Explore upcoming changes in global regulation Supply Chain Optimization Criteria for Medical Device commercialization success Panel Discussion Advanced Technology How to choose Vendors/Suppliers Note: Use coupon code NB5SQH8N and get 10% off on registration.
  • 6 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.
  • 7 Request Info

    6-Hour Virtual Seminar on FDA Scrutiny of Promotion and Advertising Practices

    If you go "off label" with advertising and promotion, FDA's hammer can hit hard and seemingly out of the blue. Advertising and promotion for devices is weak and lacks legal clarity. For drugs, the regulations are prescriptive and guidance documents clamp down on nuances. Marketing and regulatory affairs departments must collaborate to avoid the hammer and penalties of FDA. The roadblock, however is that marketing managers and regulatory affairs managers rarely reach common ground and are loathe to even consult with each other.
  • 8 Request Info

    6-Hour Virtual Seminar on Transition from Peer to Supervisor

    Today's workforce is experiencing high turnover and disengaged employees. It is a known fact that employees quit managers- to avoid turnover it is critical to have the appropriate skills to retain employees. Transition from a Peer to Supervisor can be very difficult for most newly promoted supervisors. Many are not equip with the tools to successfully transition. This seminar will equip newly promoted supervisor with tools and techniques to decrease turnover, increase employee engagement and increase employee productivity.
  • 9 Request Info

    A Bulletproof, Cost-Efficient Supplier Management Program

    This webinar will review in detail the FDA QSR and ISO requirements for supplier evaluation and assessment, and discuss cost effective options for many of the common practices for achieving compliance. Why Should You Attend: Supplier qualification and assessment is required according to both QSR regulations and ISO standards. Who Will Benefit: This webinar will provide valuable assistance to all regulated companies that are interested in implementing a supplier management program that is both compliant and cost-efficient. The employees who will benefit include: Purchasing management Regulatory management QA management Consultants Instructor Profile: Jeff Kasoff, RAC, is the director of quality at Medivators, a leading manufacturer of endoscopy consumables and instrumentation. Use coupon code 232082 and get 10% off on registration.
  • 10 Request Info

    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.
  • 11 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
  • 12 Request Info

    Addressing CAPA within a Device Quality System

    Overview: This webinar will help you ensure an efficient and effective CAPA process leading to improved quality and compliance for your company. You’ll learn how to streamline and monitor your process to ensure compliance and improved performance. If your CAPA process needs a CAPA this webinar is for you.
  • 13 Request Info

    Advanced Topics in Biostatistics for Non-Statisticians

    This pharmaceutical and medical device training course begins with a brief introductory discussion that will introduce and outline the types of clinical investigations conducted. This includes Phase II (non- randomized and randomized) and Phase III randomized clinical trials. It will emphasize the principles of clinical investigations and the issues to be addressed in the remainder of the course. Also the concept of the p-value and power will be reviewed. Statistical topics will include, but are not limited to: •Multiple primary and secondary endpoints in clinical trials and the techniques for addressing the multiple testing procedures that have been proposed •Missing data in clinical trials, the types of missing data that can arise and the issues involved for handling and interpreting the results from lack of data •Adaptive designs in clinical studies when an interim analysis indicates a possible midway correction in study design to preserve the integrity of the study . .
  • 14 Request Info

    Adverse Drug Events - Reporting & Regulatory Requirements

    This course will provide participants with an understanding of drug safety at the investigational stage and during the marketing phase. Adverse event identification and reporting requirements will be addressed, as well as FDA, EMA, Health Canada and ICH roles in the drug safety process. The course will also discuss international law/regulations, ICH guidelines, Pharmacovigilance, definitions and current regulatory issues. Adverse Event reporting requirements specific to the US, Canada, Japan, and Europe will be discussed and compared in detail. Participants will be provided with templates for reporting requirements in each region covered. Multiple exercises are included to reinforce the lecture material. Through the use of various scenarios, participants will learn how to assess and report AEs including SAEs.
  • 15 Request Info

    Applied Statistics for QA, QC, Manufacturing, and Design Control

    The 2-day seminar begins with an examination of ISO and FDA regulations and guidelines regarding the use of statistics. Basic vocabulary and concepts are then reviewed and discussed. The flow of subsequent topics over the 2 days is as follows: • How to calculate confidence intervals (for proportions and for measurements), including a discussion of how to choose sample size • How to perform an interpret t-Tests, including consideration of "significance", "p-values", "power" and sample-size considerations • How to perform calculation of confidence/reliability for attribute data
  • 16 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
  • 17 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
  • 18 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
  • 19 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.
  • 20 Request Info

    Audit - How to Improve Your Internal Audit program - 2017

    Overview: This webinar will explore how to improve your internal audit program so it is the efficient and effective tool it is meant to be. Internal Audit is a required part of an effective quality system. More importantly, it is an incredibly powerful tool to identify areas of non-compliance. A well-designed audit program can be an effective tool in understanding, communicating, and reducing compliance risk.