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Enroll three students in the same course (held on the same date and at the same location) at the regular price and receive a fourth enrollment for free. *This offer cannot be combined with any other promotional offer(s).

Medical Device Complaint Handling, Event Reporting, and Recall Management Training

Can't travel? This class is available as a online, virtual seminar!

With a new emphasis on total life cycle management, regulators are increasingly turning their attention to postmarket regulations. Evidence can be seen in the new EU Medical Device Regulation, changes in ISO 13485:2016, and FDA guidance. Today you are expected to demonstrate that you have effective and proactive performance monitoring procedures. This is an area you cannot afford to ignore.

Over 3 engaging days you’ll cover a range of topics, including following postmarket surveillance best practices, addressing field corrections and recalls, and managing audits by global regulators (including MDSAP auditors).

 

 

Upcoming Dates and Locations

Virtual seminars run as 1/2-day sessions. In-person classes run as full-day sessions. See the virtual session daily class times.

Location Start Date Days Cost Public Course Private
VIRTUAL DELIVERY (PM) 08/10/2020 5 $2995.00 Add to Cart CONTACT US
VIRTUAL DELIVERY (PM) 09/21/2020 5 $2995.00 Add to Cart CONTACT US
Orlando, FL 10/13/2020 3 $2995.00 Add to Cart CONTACT US
VIRTUAL DELIVERY (PM) 11/02/2020 5 $2995.00 Add to Cart CONTACT US
VIRTUAL DELIVERY (PM) 12/14/2020 5 $2995.00 Add to Cart CONTACT US
San Diego, CA 12/15/2020 3 $2995.00 Add to Cart CONTACT US

What You Will Learn

At the conclusion of this workshop, you will be able to:

  • Describe the role of risk management and CAPA in effective complaint handling, as well as key regulatory requirements for handling complaints, vigilance, and field actions.
  • Identify best practices for structuring your complaint-handling process and department.
  • Perform complaint intake, triage, investigation, and closure with confidence.
  • Identify reporting requirements in the US, EU, China, and MDSAP countries.
  • Understand PMS requirements, including those in the EU Medical Device Regulation (2017/745) and ISO 13485:2016.
  • Apply a risk-based approach to needed corrections and removals.
  • Prepare your team for audits of your complaint-handling system, including those by FDA, Notified Bodies, and MDSAP auditors.
  • Explain the relationship to risk management using ISO 14971 and linkages with corrections, removals, and recalls.

Who Should Attend

Quality and regulatory managers in medical device companies or anyone who needs to understand and apply the regulatory requirements for complaint handling and event reporting. All attendees must have a basic familiarity with FDA 21 CFR Part 820 and ISO 13485.

Virtual Class Days

Virtual Class Days: 5 days, daily 1:30  - 5:00 PM EST

In-Person Days: 3
CEUs: 2.5

Virtual Session Details

The same great training, from the comfort of your home or office

Oriel STAT A MATRIX Virtual Instructor-Led Training (VILT) is a real-time internet-based learning experience where the instructor and learners are in separate locations. Oriel STAT A MATRIX’s VILT technology platform is designed to simulate a traditional in-person classroom experience and allows for 2-way dialogue, break-out sessions for engaged workshops and hands-on exercises, and group work using virtual breakout rooms. This provides for an engaging learning experience in which participants can connect with the content and interact with both the instructor and other classmates.

This class can also be delivered as a private virtual learning exclusively for your company. 

Online Training Schedule

  • This training is delivered as five consecutive half-day sessions.
  • Daily sessions run from 1:30-5:00 p.m. Eastern Standard Time (EST).
  • This convenient half-day format allows you to balance your other responsibilities while still getting the training you need. 

Technical /Logistical Requirements

To participate in this learning, first and foremost, we need your engagement!  You will also need:

Tablets and mobile devices may lack some essential functionalities and are not recommended.  

Click here to find a class.

  • This training is delivered as five consecutive half-day sessions.
  • Daily sessions run from 1:30-5:00 p.m. Eastern Standard Time (EST).
  • This convenient half-day format allows you to balance your other responsibilities while still getting the training you need. 
VIRTUAL CLASS TIMES Close

Public virtual seminars run daily from 1:30-5:00 p.m. EST (3.5 hours each day).

Auditor classes that that require a final exam are extended by 2 hours on the last day to administer the final exam.

For more information download the virtual course agenda (close this window and navigate to the top of the course page) or Contact Us.

Get answers right now. Call 1.800.472.6477

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