Xavier Health
QA/RA Institute for Medical Device Professionals
 

Upcoming Courses
At-A-Glance

Live Webinars

Design Controls Series: Certificate Program

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09/18/2012 - 08/20/2013 12-month Series

Join us and enhance your knowledge and skills and obtain application tools during a 12-month series focused on all aspects of design controls.

Earn a 10% discount when enrolling for the entire 12-course series!

Design Controls Module 1: Introduction to Design Controls

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**Available for Immediate Access** This 1.5-hour Webinar includes an overview of regulations and guidances, as well as interdependencies and functional responsibilities.

Design Controls Module 2: Design Planning and Design History File

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This 1.5-hour Webinar explores the requirements for design planning and design history files and implementation tools to meet the requirements.

Design Controls Module 6: Design Verification and Validation

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This 1.5 hour webinar will cover key criteria of Design Verification and Validation.

Design Controls Module 3: Design Inputs

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This 1.5-hour Webinar explores the requirements for design inputs (including sources for design inputs) and implementation tools to meet the requirements (including how to write good design inputs).

Design Controls Module 4: Risk Management

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This 1.5-hour Webinar will explore the requirements for risk management and implementation tools to meet the requirements.

Design Controls Module 5: Software Validation

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This 1.5-hour Webinar will explore the requirements for Software Validation and implementation tools to meet the regulatory requirements.

Design Controls Module 8: Design Outputs and Transfer

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This 1.5-hour Webinar will explore the requirements for Design Outputs and Design Transfer and implementation tools to meet the regulatory requirements.

Design Controls Module 9: Design Changes

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This 1.5-hour Webinar will explore the requirements for Design Changes and implementation tools to meet the regulatory requirements. Participants will discuss an approach to analyze impact of design changes to ensure all portions of your design controls are addressed (e.g., repeating verification testing, updating risk management file, updating component specification, repeating process validation).

Design Controls Module 10: Design Defect Management

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This 1.5-hour Webinar will explore the regulations related to defect management, key process interdependencies (e.g., with CAPA and Complaint Handling), and possible approaches to managing and handling design defects.

Benchmarking New Requirements of the FDA Safety and Innovation Act (Part 1)

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The FDA Safety and Innovation Act (FDASIA) is more than just a user fee schedule: there are other provisions that will change your manufacturing and product approval processes. Significant changes to law affecting FDA regulation have not occurred in over a decade and will have an impact on the Medical Device Industry. These new requirements go into effect in 2013, are you prepared? **Register for all 3 webinars and receive a 10% Discount!**

Benchmarking New Requirements of the FDA Safety and Innovation Act (Part 2)

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The FDA Safety and Innovation Act (FDASIA) is more than just a user fee schedule: there are other provisions that will change your manufacturing and product approval processes. Significant changes to law affecting FDA regulation have not occurred in over a decade and will have an impact on the Medical Device Industry. These new requirements go into effect in 2013, are you prepared? **Register for all 3 webinars and receive a 10% Discount!**

MDR Module 8: MDR Exemptions

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The Medical Device Reporting webinar series goes “Beyond CDRH Learn,” and includes answers to FAQ’s obtained from industry thought leaders and industry experts joining several of the sessions to share best practices.

MDR Module 1: FDA Expectations - Compliant Medical Device Reporting Systems

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The Medical Device Reporting webinar series goes “Beyond CDRH Learn,” and includes answers to FAQ’s obtained from industry thought leaders and industry experts joining several of the sessions to share best practices.

MDR Module 4: MDR Procedures

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The Medical Device Reporting webinar series goes “Beyond CDRH Learn,” and includes answers to FAQ’s obtained from industry thought leaders and industry experts joining several of the sessions to share best practices.

MDR Module 5: Improving the Quality of your MDR

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The Medical Device Reporting webinar series goes “Beyond CDRH Learn,” and includes answers to FAQ’s obtained from industry thought leaders and industry experts joining several of the sessions to share best practices.

MDR Module 6: Investigation of Events

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The Medical Device Reporting webinar series goes “Beyond CDRH Learn,” and includes answers to FAQ’s obtained from industry thought leaders and industry experts joining several of the sessions to share best practices.

MDR Module 7: CFR 803 Definitions

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The Medical Device Reporting webinar series goes “Beyond CDRH Learn,” and includes answers to FAQ’s obtained from industry thought leaders and industry experts joining several of the sessions to share best practices.

MDR Module 9: Differences between Medical Device Reports and Vigilance Reports

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The Medical Device Reporting webinar series goes “Beyond CDRH Learn,” and includes answers to FAQ’s obtained from industry thought leaders and industry experts joining several of the sessions to share best practices.

MDR Module 10: Managing Global Expectations for Medical Device Reporting. Panel Session.

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The Medical Device Reporting webinar series goes “Beyond CDRH Learn,” and includes answers to FAQ’s obtained from industry thought leaders and industry experts joining several of the sessions to share best practices.

MDR Module 11: Ask the Experts Session

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The Medical Device Reporting webinar series goes “Beyond CDRH Learn,” and includes answers to FAQ’s obtained from industry thought leaders and industry experts joining several of the sessions to share best practices.

MDR Module 2: eMDR Implementation

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The Medical Device Reporting webinar series goes “Beyond CDRH Learn,” and includes answers to FAQ’s obtained from industry thought leaders and industry experts joining several of the sessions to share best practices.

MDR - Complete Series

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The first and only comprehensive coverage of FDA expectations and industry solutions for Medical Device Reporting. The CDRH/Xavier Webinar Series is a monthly program which began in June 2011. It has been developed to offer you comprehensive coverage of FDA expectations and industry proven solutions on the topic of Medical Device Reporting. This educational series, developed by the FDA and Xavier University, will be the only A to Z blueprint for MDR’s that you as a medical device company will be able to access.

Post-Market Surveillance Series Module 1: Introduction to Post-Market Surveillance

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This 1.5 hour introductory webinar will take a broad look at the overall system of post-market surveillance and how it relates to other critical processes. A dynamic Question and Answer session will be held at the end of the presentation.

Post-Market Surveillance Series

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This six webinar course series will focus on the key aspects of a robust post-market surveillance system including: a broad overview perspective, complaint handling, MDR, vigilance, corrections & Removals, and operational strategy. Join FDA and industry experts for this dynamic series that will enhance your post-market system.

Post-Market Surveillance Series Module 2: Complaint Handling

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This 1.5 hour introductory webinar will take a broad look at the overall system of post-market surveillance and how it relates to other critical processes. A dynamic Question and Answer session will be held at the end of the presentation.

Post-Market Surveillance Series Module 3: Medical Device Reporting (MDR)

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Join this 1.5 hour webinar for a deep dive into the key components of a MDR report and how to meet FDA expectations.

Post-Market Surveillance Series Module 5: Corrections & Removals or Recalls

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This 1.5 hour webinar covers the full gamut corrections, removals and recalls

Post-Market Surveillance Series Module 6: Operationalizing Post-Market Surveillance in a Global Company

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This 1.5 hour webinar focuses on how to make Post-Market Surveillance work in a global company and will include a dynamic panel discussion that will answer your questions to make your company system stronger.

Post-Market Surveillance Series Module 4: Vigilance

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This 1.5 hour webinar discusses the importance of vigilance in all areas of post-market surveillance.

Advanced Post-Market Surveillance Series

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This two-part series will focus on Advanced Post-Market Surveillance topics. We highly recommend (but not require) that you view the six-part Post Market Surveillance Series prior to this two-part advanced series in order to achieve maximum understanding and value. This series builds on and utilizes information shared in the Medical Device Reporting and Design Controls Series.

Regulatory Submission Series Module 1: Setting the Strategy for your Company’s Submission Process

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This six-part series serves as a “How to Guide” for the Regulatory Professional with a focus on discussing the most important components of 510 (k) submissions and working with FDA.

Regulatory Submission Series Module 2: Setting the Foundation for Successful Approval

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This six-part series serves as a “How to Guide” for the Regulatory Professional with a focus on discussing the most important components of 510 (k) submissions and working with FDA.

Regulatory Submission Series Module 4: Constructing a Robust Submission

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This six-part series serves as a “How to Guide” for the Regulatory Professional with a focus on discussing the most important components of 510 (k) submissions and working with FDA.

Regulatory Submission Series Module 6: Changes that Trigger Post-Market Submissions

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This six-part series serves as a “How to Guide” for the Regulatory Professional with a focus on discussing the most important components of 510 (k) submissions and working with FDA.

Benchmarking New Requirements of the FDA Safety and Innovation Act (Part 3)

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TBD

The FDA Safety and Innovation Act (FDASIA) is more than just a user fee schedule: there are other provisions that will change your manufacturing and product approval processes. Significant changes to law affecting FDA regulation have not occurred in over a decade and will have an impact on the Medical Device Industry. These new requirements go into effect in 2013, are you prepared? **Register for all 3 webinars and receive a 10% Discount!**

FDASIA - Complete Webinar Series

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12/12/2012 - 12/31/2014 12:00pm - 1:30pm (EST)

The FDA Safety and Innovation Act (FDASIA) is more than just a user fee schedule: there are other provisions that will change your manufacturing and product approval processes. Significant changes to law affecting FDA regulation have not occurred in over a decade and will have an impact on the Medical Device Industry. These new requirements go into effect in 2013, are you prepared?

Regulatory Submission Series

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06/17/2014 - 11/20/2014 12:00pm - 1:30pm

This six-part series serves as a “How to Guide” for the Regulatory Professional with a focus on discussing the most important components of 510 (k) submissions and working with FDA.