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.
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
- Contract Laboratory
- Packaging and Labeling
- Distributors and Wholesalers
Pr. Peivand Pirouzi, Ph.D., MBA, CCPE
Peivand holds a Ph.D. in Physiology and Biophysics from the School of Medicine, University of Sherbrooke , an M.B.A. 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 experience in working at Wyeth/Pfizer, ApoPharma/Apotex, collaborations with EliteMed, and Medipure Pharmaceuticals and includes the management of more than 40 international clinical studies for pre and post marketing phases and participation in pre and post marketing regulatory activities and strategic planning, managing of pre and post marketing safety reporting, risk mitigation strategies, and pharmacovigilance activities, registration of medical devices, natural health products, cosmetics, medical Marihuana licensed and new drug submissions for pharmaceuticals and writing companywide policies and SOPs.
Peivand’s government and corporate training experience covers companywide pharmaceutical and sales training on multitude of subjects. He has an extensive pharmaceutical teaching experience to the personnel at Health Canada inspectorate (In Pharmacovigilance), Nestlé, Teva, Biopharma Services, , Astellas, Saudi FDA, Cynapsus Therapeutics, MacFarland Quality Systems, CommunaPharm Consulting, Nucro-Technics, University of Manitoba, MuskokaPharma, Regxia, Septodont, a Novocol Pharmaceutical division, EliteMed, Virbac, Omnnivet Pharma, CanAssisst Canada, University of Guelph, Rejunen8 Laboratories, Medipure Pharmaceuticals, Jem Farms, Toronto Herbal Remedies, Orange Green, true Medicine, CDS Medical Cannabis Farm, 3M, and Patheon.
Peivand’s academic experience includes medical and academic research and teaching since 1991. As a professor in graduate and post graduate programs, Peivand’s professional experience includes teaching Pharmaceutical Clinical Research, Regulatory Affairs and Registration, Quality Control and Audits, Regulatory Compliance, Bioethics, Clinical Pharmacology, Psychiatry, Psychophysiology, Neurophysiology, Medical Biochemistry, Microbiology, Microbial Ecology, Virology, and Genomics.
Peivand has authored more than 65 scientific realizations, including 12 publications in National Library of Canada, articles in peer-reviewed journals, oral and poster presentations, and more than 1000 technical and scientific reports.
Peivand has received several awards and recognitions including “A Scientific Recognition and Awards” from His Very Honorable Bernard Landry, the Premier of Quebec, a “letter of commandment” from the Dean, School of Health Sciences, Humber Institute of Technology and Advanced Learning for teaching excellence. Peivand is a member of the board of directors at the Persica Management and Quality Association in Toronto, an the executive director for Pharmaceutical, Medical Devices, and project management divisions, and a mentor for immigrants and refugees who are international medical and science graduates in the York region.
Registration Deadline: 10 Jul 2017
|Basic Member Promo:||$375.00||— Sold Out|
|Basic Member Group Tickets Promo:||$355.00||— Sold Out|
|Student Ticket:||$250.00||— Sold Out|
|Pro Ticket Promo:||$345.00||— Sold Out|
|Pro Group Tickets Promo:||$325.00||— Sold Out|
|Basic Member Regular:||$525.00||— Sold Out|
|Basic Member Group Tickets Regular:||$505.00||— Sold Out|
|Pro Ticket Regular:||$495.00||— Sold Out|
|Pro Group Tickets Regular:||$475.00||— Sold Out|