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
Ethical considerations (IEC, IRB)
Adverse Event (AE) reporting
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.
|Single Day Non-Member Ticket:||$525.00||— On Sale||Until: 08/08/18 4:00 PM|
|2-Day Non-Member Ticket:||$890.00||— On Sale||Until: 08/08/18 4:00 PM|
|Single Day Pro/Pro Plus Member Ticket:||$495.00||— On Sale||Until: 08/08/18 4:00 PM|
|2-Day Pro/Pro Plus Member Ticket:||$840.00||— On Sale||Until: 08/08/18 4:00 PM|