Xavier Health
QA/RA Institute for Medical Device Professionals
 

Upcoming Courses
At-A-Glance

Series and Certification Programs

Advanced Post-Market Surveillance Series

Post-Market Surveillance is of paramount importance for ensuring safety and efficacy of medical devices that are being marketed. Myriads of changes are coming in the regulations internationally. The US and EU specifically require innovative thinking in effectively handling these changes. This two-part webinar series analyzes the current international perspective of post-market surveillance and the most frequent issues companies face. Along with these topics, the webinars will also discuss the various challenges and best practices to streamline and harmonize the post-market surveillance process. Taking these issues as a backdrop, these webinars discuss the business strategies for managing the post-market surveillance function to improve quality, cost and timeliness while ensuring regulatory compliance.

Part 1: Post-Market Surveillance Function – Manage it efficiently and effectively

Part 2: Harmonizing Post-Market Surveillance Processes

Design Controls Series Certificate Program

Design Planning – Design Inputs – Design Outputs – Design Verification and Validation – Design Changes – Design Reviews – Design Transfer – Design Defect Management – Design History Files – Risk Management… are any of these areas of your responsibility? Are you part of a design team to ensure product safety and efficacy?

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

Coursework offered through the Xavier QA/RA Institute focuses on QA/RA areas of interest with special emphasis on providing participants with a working knowledge to facilitate application of learnings.

**Receive 10% Discount for purchasing all 10 modules at once**

FDASIA Series

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?

This webinar series will occur semi-annually, allowing you to benchmark where you and your company stand as the provisions of FDASIA go into effect over 2013.  The webinars will provide details of the new law that directly impact the Medical Device Industry from experts and the FDA.  Use the FDASIA benchmarking webinar series to evaluate your company’s compliance to the new FDA expectations and requirements.  Our experts will provide company leaders with the tools to stay on course for compliance as the FDA’s expectations evolve over 2013.

**Receive a 10% Discount for purchasing all 3 webinars at once**

How to Implement the Unique Device Identification

The 2012 law called FDASIA extended FDA’s authorities in ways that could toughen the bite of inspections, and require greater transparency about the source of devices to improve the quality of post-market data and reduce medical errors. The Universal Device Identifier, like a car’s VIN provides important information about the pedigree of devices. Use of UDI will improve the quality of post-market data, improve recalls and enable firms to better trend information about how their devices are performing in the market. Implementing UDI presents great logistical challenges and depending on the device, may present more than a few alternative ways to accomplish the necessary identification steps. This panel will update current FDA plans for the rollout and implementation of the new UDI rule.

MDR Series

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.

Post-Market Surveillance Series

A 2011 IOM report (“Medical Devices and the Public’s Health: The FDA 510(k) Clearance Process at 35 Years”) recommended that the FDA strengthen post-market surveillance activities in order to better protect patients and to better utilize post-market data.  Therefore, the FDA has placed creating a more comprehensive medical device post-market surveillance strategy as one of their top strategic priorities of 2013. 

In an effort to strengthen the industry’s post-market activities, Sharon Kapsch, Chief of the MDR Policy Branch within FDA CDRH’s Office of Surveillance and Biometrics, has helped design this series to provide an intermediate level of understanding to achieve a robust post-market surveillance strategy.  There will be 6 modules covering the following topics in detail:

  1. Post-Market Surveillance: An Introduction
  2. Complaint Handling
  3. MDR
  4. Vigilance
  5. Corrections & Removals (US) or Recalls (abroad)
  6. Overview: Operationalizing Post-Market Surveillance in a global company and Panel discussion

This series is a continuation of our MDR webinar series (also designed by Sharon Kapsch).  We highly recommend (but not required) that you watch the MDR series prior to attending the Post-Market Surveillance series in order to achieve maximum value.

**Receive a 10% Discount for purchasing all 6 modules**

Regulatory Submission Series

The Regulatory Professional serves a vital role in new product development for Medical Device Companies. The ultimate goal of the Regulatory Professional is to successfully select the correct regulatory pathway for a new device, construct and file a robust submission, and proactively respond to FDA decisions—keeping patient safety and product effectiveness in mind throughout. The Regulatory Professional must also know how to quickly react to design changes and other post-market occurrences. This series will provide the Regulatory Professional with the information and insights necessary to make these timely and important decisions to improve patient outcome and in turn support business success.