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

This webinar will provide an overview of mobile medical apps and discuss when the app becomes the FDA regulated medical device. It will also discuss the cybersecurity requirements for mobile apps.

This webinar will cover all relevant regulatory requirements (CFR, FDA, ISO, ASTM and European) for establishing the stability and determining the shelf-life of medical devices. Attendees will gain a better understanding of the design control process for designing medical devices.

This training program will examine how human factors/usability is the analysis of how people interact with medical devices. The process of conducting rigorous human factors studies throughout the design process, integrating it with the device risk analysis and design process and validating the effectiveness of the studies will be explained. The various types and methods of human factors analysis will be explained. This process conforms to the new ISO 62366 standard and the new FDA guidance document.

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. It will provide practical guidance on achieving the CE mark. Medical devices sold into the European Union (EU) must comply with the applicable medical device directives and EU laws similar to FDA’s regulations.

This webinar provides a basic understanding of the records required to fulfill requirements of both US FDA 21CFR 820 and ISO 13485:2016 for establishment and maintenance of a Device Master Record. It will further discuss the responsibilities of various development team members such as R&D/engineering, operations, quality assurance, project management and executive management.

This webinar will introduce attendees to key components of a computerized system validation master plan and set out the requirements for compliance as per FDA’s 21 CFR 11. It will detail several aspects such as requirements, design, configuration specifications, validation testing, procedures/archival/traceability, and best practices for system decommissioning/retirement as well.

This webinar will cover FDA’s current thinking on QRM and Guidance for Industry - Q9 Quality Risk Management, provide information to help understanding of QRM concepts, and applications. In addition, brief review of how ICH Q8, Q9, and Q10 work in coherence throughout product lifecycle.

Attend this webinar to increase one’s knowledge of FDA inspections, what inspectors are looking for and expect to see and not to see in manufacturing facilities. It will provide an in-depth understanding of how to prepare for unannounced FDA audits and inspections.

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.

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 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 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 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.

Lean implementation is not confined to just manufacturing. It can be appropriately applied throughout the organization in all functions. This virtual training program, however, focuses on manufacturing, where lean was born. The difference between this treatment of lean application and others is that we have imbedded the concept of GMP and compliance into our lean model to make it particularly applicable to the life sciences.