Putting learning in your hands, the Xavier Health Webinar Toolbox includes a wide range of online video courses taught by thought-leaders in the FDA and industry. Earn certification and CEUs as you gain valuable insight that will foster career growth. Here's an overview of all our courses:

 

Combination Products Primer Webinar Series

This webinar series is prepared for you and your team to use as a foundational resource on critical aspects of combination product development, submissions, and on-market safety.

Modules in this Series:

  1. Introduction to Combination Products and Quality System Regulations
  2. Integrated Development
  3. Submission Strategies and Post-Approval Changes for Drug-Led Combination Products
  4. Post-Market Safety Reporting

Half Day with FDA

CDER, CDRH and ORA are going through dramatic changes:

  • Different timelines
  • Different drivers
  • Different organizational structures
  • Different execution
  • Different impact on pharmaceutical and medical device firms

Through this webinar, we bring all the alignment and reliance initiatives together to increase your understanding of the bigger picture, so you can better collaborate with FDA and understand how to navigate through these changes for the success of the patients you serve.


Design Controls Series Certificate Program

Enhance your knowledge and skills and obtain application tools during a 10-part series focused on all aspects of design controls. Coursework focuses on QA/RA areas of interest with special emphasis on providing participants with a working knowledge to facilitate application of learnings.

Modules in this Series:

  1. Introduction to Design Controls
  2. Design Planning and Design History File
  3. Design Inputs
  4. Risk Management
  5. Software Validation
  6. Design Verification and Validation
  7. Design Reviews and Design Quality Experts
  8. Design Outputs and Transfer
  9. Design Changes
  10. Design Defect Management

Medical Device Reporting (MDR) Series

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

Modules in this Series:

  1. FDA Expectations - Compliant Medical Device Reporting Systems
  2. eMDR Implementation
  3. MDR Procedures and Event Files
  4. Improving the Quality of your MDR
  5. Investigation of Events
  6. CFR 803 Definitions
  7. MDR Exemptions
  8. Differences between Medical Device Reports and Vigilance Reports
  9. Managing Global Expectations for Medical Device Reporting. Panel Session.
  10. Ask the Experts Session

Post-Market Surveillance Series

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

Modules in this Series:

  1. Introduction to Post-Market Surveillance
  2. Complaint Handling
  3. Medical Device Reporting (MDR)
  4. Vigilance
  5. Corrections and Removals or Recalls
  6. Operationalizing Post-Market Surveillance in a Global Company

Advanced Post-Market Surveillance Series

This two-part series focuses 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.

Modules in this SerieS:

  1. Manage Post-Market Surveillance Functions Efficiently and Effectively
  2. Harmonizing Post-Market Surveillance Processes

Regulatory Submission Series

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.

Modules in this Series:

  1. Setting the Strategy for your Company’s Submission Process
  2. Setting the Foundation for Successful Approval
  3. Verification of the Foundation
  4. Constructing a Robust Submission
  5. Submission Review and Outcomes
  6. Changes that Trigger Post-Market Submissions

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.


Sweeping De-Regulation through the 21st Century Cures Act?

Although touted to accelerate the discovery and development of new medical products, the de-regulation of FDA approval authority through the 21st Century Cures Act is reminiscent of pre-1962 times. Instead of accelerating innovation, the Act might just allow under-developed products to reach the market that have been prevented for decades. The Act has been passed, the rules have been changed, and your products have already been impacted – including new competitors you might not have had before. Learn from subject expert, Jim O’Reilly, the extent of impact we will witness for years to come.