Medical Device Regulatory Compliance Training - Live Webinars, Recordings & CDs

This Regulatory compliance training is designed to provide an overview of the regulatory environment throughout Europe and will explain how the EU interacts with national regulatory agencies.

This webinar will focus on the recent changes to the ISO 9001 and ISO 13485 quality management system (QMS) standards. Participants will be provided with the tools necessary to help their company plan for the transition to the new editions.

This webinar will cover in detail the steps to plan and conduct a program to qualify contract manufacturer organizations (CMOs). It will teach best practices to meet regulatory requirements and satisfy practical needs to obtain the best CMO.

This webinar will provide an overview of SEC Whistleblower Rules such as False Claims Act, Dodd-Frank, Sarbanes-Oxley and Commodity Exchange Act. It will also discuss best practices on how to mitigate damages from an actual or purported whistleblower.

To provide a clear understanding on impact the EU Commission Recommendation has had on tighter controls, roles and further responsibilities of Notified Bodies and other changes, which will impact manufacturers and their corresponding suppliers. As a result, this webinar furnishes details on how can these latter parties prepare for a Notified Body routine surveillance and unannounced audits. Advance preparation and planning to these changes and others, will help you have a smoother transition to what is expected and required. This webinar will also provide the challenges and benefits of successful results from Notified Body routine and unannounced audits.

This webinar will explain FDA QSR requirements for acceptance activities related to medical device manufacturing. It will analyze recent Warning Letters and provide tips to ensure that your acceptance activities fully complies with the regulatory requirements.

This webinar will explain how to use ANSI/ASQ Z1.4 to define sampling plans including its switching rules. It will also offer an inspection plan format that reduces the sequential sampling plan to ten or fewer rows in most cases.

This device compliance training will offer a basic understanding of the records required to fulfill requirements of both US FDA 21 CFR 820 and ISO 13485:2016 for establishment and maintenance of a Design History File (DHF). It will also help attendees understand what document control means for DHF records.

This webinar will cover US FDA and Customs legal import requirements including discussion on FDA product codes, Custom's Harmonized Tariff Schedule (HTS) and Affirmation of Compliance (AOC). It will also provide information on FDA's software screening program, PREDICT, and U.S. Custom's ACE program.

This webinar will provide valuable assistance to all regulated companies; a CAPA program is a requirement across the Medical Device, Diagnostic, Pharmaceutical, and Biologics fields.

This webinar will focus on most trustworthy open access resources. It will also provide tips on how to gain access to hard-to-find materials by paying high subscription or membership fees.

This medical device verification and validation training will dissect some of the FDA 483 observations related to design verification and design validation, and provide key information on how they can be prevented.

This training program will address when to exclude outlying data points from an analysis. It will illustrate how best to apply sensitivity analysis to determine the impact of removing data. Participants will learn to perform and interpret hypothesis tests for outlier detection.

This 90-minute webinar covers all aspects of post market surveillance (PMS) for medical devices. It will direct you to the specific documents for the detailed information you need for an effective post-market surveillance system.

This medical device training program will provide an understanding of creative methodologies to solve design and development challenges of connected solutions for patient monitoring, scheduling, tracking, or drug delivery. It will demonstrate how consumer technologies vary by level of complexity and how they can be used in healthcare.

This webinar will provide an understanding of the organizational hierarchy of FDA and Health Canada, your regulatory and quality compliance obligations and the implications of the interactions between these two agencies on your organization.

This medical device software development, verification and validation training package of four courses covers wellIEC 62304 requirements and explains risk based approach for validation using validation protocols and GAMP®.

This training program will provide an understanding of key areas of design focus for medical wearables. Attendees will learn best practices to implement product development plan that apply to medical devices.

Many companies offer their devices in the EU, so must comply with the EU UDI regulations. There are significant differences from the US system. While some details remain, there is sufficient information to allow companies to start planning. This webinar can help you prepare for this major aspect of the new EU regulations.

This training will discuss the final guidance on postmarket management of cybersecurity in medical devices which was released in Dec. 2016. Attendees will learn how to establish a risk-based framework for assessing when changes to medical devices for cybersecurity vulnerabilities require reporting to the FDA.