Medical Devices – A Two Part Series in Montreal
Expired

  • Part 1November 13, 2017
    9:00 am - 4:00 pm
  • Part 2November 14, 2017
    9:00 am - 4:00 pm

Location

6700 Trans-Canada Hwy, Pointe-Claire, Quebec, Canada, H9R 1C2
QA RA

Certification Areas

Medical Devices Part I- Introductory Course

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

 

The main course objective is to learn about Medical Device Regulations in Canada and in the USA.  Attendees will gain deeper understanding of the quality and regulatory environment in which medical devices are manufactured, distributed and imported

 

Key points will include:

  • Medical Device Regulations in Canada and the U.S.A.  
  • 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

 

Individuals in Regulatory affairs, Quality Assurance, Validation, QC Laboratories, Contract Laboratories, and Manufacturers should attend this course.  In addition Trainers, Consultants, Distributors & Wholesalers as well as Importers would benefit from attending.

 

Medical Devices Part II- Advanced Course

Regulations for Investigational Testing Involving Human Subjects

 

This intensive 1-day comprehensive course provides participants with a solid understanding of the Medical Device Regulations in Canada and the USA as well as the procedures for Investigational Testing involving Human Subjects.  It will also give insight to the requirements for advertisement, labelling, study conduct and monitoring, reporting Adverse Events, complaint handling and how all of these apply to a quality management system

 

Key points will include:

Applications for clinical testing

ICH-GCP and quality systems

Study design

Ethical considerations (IEC, IRB)

Adverse Event (AE) reporting

Audit/Inspection procedures

Handling of Personal Health Information 

 

 

Regulatory Affairs Professionals, Quality Assurance Personnel, Clinical Research Associates, Drug Safety and Pharmacovigilance specialists, Medical Science Liaisons, Sales and Marketing Individuals involved in KOL relationship management, Trainers, and Consultants will all benefit from attending Part II.

 

SPEAKER: Peivand Pirouzi, Ph.D., MBA. CCPE

 

Peivand holds a Ph.D. in Physiology and Biophysics from School of Medicine, University of Sherbrook, and MBA from American Business Administration Institute, and he is accredited by the Canadian Council of Pharmaceutical Education with certifications in Evidence Based Medicine, Psychiatry, and Management.

Peivand’s industrial experience includes Wyeth/Pfizer, ApoPharma/Apotex, as well as collaborations with EliteMed and Medipure Pharmaceuticals.  His government and corporate training experience covers companywide pharmaceutical and sales training on a multitude of subjects.

He has extensive pharmaceutical teaching experience to personnel ranging from Health Canada Inspectorate (in pharmacovigilance) to pharma industry organizations such as Nestle, Teva, Biopharma Services, 3M, Medipure Pharmaceuticals, and Patheon.

He has authored more than 65 scientific realizations, including 12 publications in the National Library of Canada, articles in peer-reviewed journals, oral and poster presentations, and more than 1000 technical and scientific reports.

www.linkedin.com/in/pirouzi



Single Day Non-Member Ticket: $525.00 Sold Out
2-Day Non-Member Ticket: $890.00 Sold Out
Single Day Pro/Pro Plus Member Ticket: $495.00 Sold Out
2-Day Pro/Pro Plus Member Ticket: $840.00 Sold Out