Skip to Page Content

Workshops

Medical Device Complaint Handling: Building an Integrated Approach for Your Company


REGISTER | INSTRUCTOR | UPCOMING EVENTS | AGENDA

Does your complaint management system provide value to your company?

It does if your company handles complaints efficiently – through the reporting, classification, investigation, corrective action, and design change phases – and your system recognizes regulatory reporting requirements, such as the Food and Drug Administration (FDA), the European Union (EU), and Health Canada, and helps you create and deliver your mandatory briefings on time.

In this two-day workshop, you will come to understand the processes and elements of an effective Quality Management System (QMS) and address critical device complaint issues in an atmosphere that encourages sharing, learning, and tool-building. Breakout sessions will provide the opportunity for you to put important lessons learned into practice. Case studies will shed light on improving your complaint handling strategies and maintaining product quality. And best of all, you'll be able to connect personally with subject matter expert and renowned instructor, Dan O’Leary, to get the one-on-one attention you need to revive or overhaul your Complaint Management System.

What You'll Cover:

 

Investigations and Corrective Action

Complaints may lead to investigations and corrective action. Our workshop will show you how to investigate complaints and execute corrective action using the elements of your QMS. You’ll also learn how to establish the interfaces between these systems, designate individuals, assign responsibility, and ensure the required skill sets, which will help you understand what to do with the results.

 

Regulatory Reporting

Complaints may represent serious events that you must report to regulatory authorities. The workshop will help you understand FDA reporting requirements for Medical Device Reports (MDRs), along with corresponding reports for the EU and Health Canada. Each of these systems has different definitions, thresholds, and time frames. The workshop will cover the basic elements of an integrated system, including:

  • Designated individuals and their required skill sets
  • Procedures to define the process and standardize work
  • Records to maintain and their prescribed content
  • Reports to file with regulatory agencies and their timeframe

Additionally, the workshop will include FDA warning letters, which will illustrate issues that other companies have faced and offer hands-on exercises designed to help you understand any challenges.

 

Design Changes

 

Corrective action may lead to design changes. How does your Design Control System handle changes? Do you know how to evaluate the change for an updated 510(k)? Do you know how to document the change in the Technical File or Design Dossier?

 

Filed Action

 

Corrective action may lead to a filed action. Do you know how to recognize the fix as an FDA correction or removal? Do you know how to report this to the FDA and understand the time frames required for reporting?

 

Register now and join your peers in Boston!

Register

 

FEATURED INSTRUCTOR

Dan O’Leary

Dan O'Leary

President

Ombu Enterprises LLC

Dan O’Leary has more than 30 years experience in quality, operations, and program management in regulated industries, including aviation, defense, medical devices, and clinical labs. He has a Masters Degree in Mathematics, focusing on logic and number theory, and his professional experience relates to quality, reliability, and operations management. Mr. O'Leary is the President of Ombu Enterprises, LLC, a company offering training and execution in Operational Excellence. Ombu helps companies achieve efficient and effective processes, along with regulatory compliance.


He is a regular speaker at international conferences and teaches courses in reliability methods, medical device regulations and practices, statistical methods, management systems (ISO 9001, FDA QSR, & ISO 13485), and project management. Mr. O'Leary is a member of the American Mathematical Society, American Statistical Association, Society of Industrial and Applied Mathematicians, Institute for Supply Management, Project Management Institute, APICS, and is a Senior Member of the American Society for Quality (ASQ) who has held leadership positions in ASQ sections. He is an ASQ-certified Biomedical Auditor, Quality Auditor, Quality Engineer, Reliability Engineer, and Six Sigma Black Belt. He holds an APICS certification in Resource Management.

REGISTRATION

Hotel Information

Hotel: Fairmont Battery Wharf

Address: Three Battery Wharf, Boston, MA 02109-1006

Phone: 617.994.9000

Date: May 3rd & 4th, 2012

Website: http://www.fairmont.com/batterywharf

Early Bird Price = $1399.00

REGISTER

Regular Price = $1699.00

Reservations: All reservations must be made individually by calling the hotel and referencing "Elsevier Business Intelligence Meeting."

Cancellations: Written cancellations received at least 21 days prior to the start date of the event will receive a refund, less a $300 processing fee. No refunds will be issued for cancellations within 21 days from the start date of the event. At that time, a credit for the amount paid, less a $300 processing fee, may be transferred to another Elsevier Business Intelligence event. No-shows will be charged the full amount. Substitutions may be made at any time by contacting Customer Care.

If the event is cancelled, you may receive a full refund. If the event is postponed, you may substitute someone else from your company. Elsevier Business Intelligence is not responsible for airfare, hotel, or other costs incurred by registrants.