Medical Device Regulatory and Quality Requirements for Manufacturers, Distributors, and Importers: Canadian and US Markets
Expired

  • July 13, 2017
    9:00 am - 4:30 pm

Location

4646 Dufferin St. Unit 6, Toronto, Ontario, Canada, M3H 5S4
QA RA

Certification Areas

Event Objective

The main course objective is to learn about Medical Devices Regulations in Canada and in the US. Attendees will gain a deeper understanding of the quality and regulatory environment in which medical devices are manufactured, distributed or imported. The outcome of this course is to adequately prepare students on working on tasks related to but not limited to: Device classification, Establishment License Requirements, Risk based classification, Labelling requirements, Complaints and recalls, Record Retention, mandatory considerations, import, manufacturing and distribution.

 

 

This course will cover Medical Device Regulations and their application to the company’s procedures and processes. The course includes an overview of Medical Device Regulations in Canada and the U.S.A. and the requirements to meet for production, distribution, or importing of medical devices. Different business scenarios including Manufacturing, and distribution will be discussed. Discussions with the students will include lessons learned from consulting experiences of the presenter and the audience.

Event Description

This one-day comprehensive and intensive course will provide attendees with the knowledge of Medical Device Regulations and their application to the company’s procedures and processes. The course covers an overview of Medical Device Regulations in Canada and the U.S.A. and the requirements to meet for production, distribution, or importing of medical devices. Different business scenarios including Manufacturing, and distribution will be discussed. Discussions with the attendees will include lessons learned from consulting and inspection experiences of the presenter.

Who Should Attend

This One-day course is applicable to the Personnel from the following areas:

 

  • Regulatory affairs
  • Quality Assurance
  • Validation teams
  • Quality Control Laboratory
  • Trainers
  • Contract Laboratory
  • Consultants
  • Manufacturing
  • Packaging and Labeling
  • Distributors and Wholesalers
  • Importers

Speaker

Registration Deadline: 10 Jul 2017



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