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Course

TORONTO

Date:	Name:	Location
Wednesday, February 3, 2010 9:00 AM TO 4:30 PM ON DAY 1 9:00 AM TO 3:00 PM ON DAY 2 (Registration 8:30 AM ON DAY 1)	COURSE FULL Medical Device Regulations and Applications for Industry: A comprehensive review of Quality and Regulatory Requirements 2-DAY COURSE Please call 905-513-7743 if you would like to be added to a waiting list	PSG Office 3780 14th Avenue, Suite 210 Markham, ON 905-513-7743
Fees:	Registration Link:	Registration Deadline
PSG Member: $560.00 + $28.00GST = $588.00 Non-Member: $680.00 + $34.00GST = $714.00	Registration for this course is currently closed.	Wednesday, January 27, 2010
Course Objective:
FEBRUARY 3RD & 4TH This hands-on 2-day course with workshop will give importers, distributors and manufacturers a complete overview of the medical device regulations and quality assurance/system requirements in Canada, to successfully do business in Canada. The course will include Health Canada regulatory requirements (incl. establishment licencing, Device Licence Applications, recall procedures, product quality applications, labelling requirements, risk classification, etc.) and also review none Health Canada requirements, i.e. CSA electrical approval, Transport of Dangerous Goods regulations, MSDS, temperature considerations, etc. Please note that this course can be considered a part of either the RA or QA certification area in the PSG Certification Program.
Course Description:
LIMITED SPACE AVAILABLE! PLEASE REGISTER ASAP TO GUARANTEE A SPOT! This 2-day course will cover the following topics: Overview of the Food and Drug Act / Regulations Medical Device Establishment Licencing (why, how etc.) Recalls Procedure (what and how) MPRS and Complaint procedures (what and how) Trade Complaints (what and how) Risk Based Classification of Medical Devices Labelling requirements for Medical Devices Medical Device Application Review process Private Labelling Special Access Program Quality system Requirements for Class II to IV Other (None-HC) consideration (CSA, Temperature, Transportation, etc.)
Course Leader:
Mia Spiegelman, B.Sc. Chemistry Mia Spiegelman is Director of National RA and QA with one of the top Medical Device importers and distributors in Canada and has key consulting and management experience in the pharmaceutical industry in Canada, including responsibility for new product importation and licencing throughout Canada, DIN applications, recalls, complaints and non-conformances. As consultant on Medical Device regulations and licensing, Mia was responsible for ensuring compliance to GMP and drug regulations and implementing policies and procedures for ISO 9001 certification, as well as coordinating the activities for device manufacturers and distributors to meet ISO 13485/88 certification. MIA served as eNOC Board member for the Canadian Association of Professional Regulatory Affairs (CAPRA) and has written for eNOC and NOC journals concerning the Medical Device industry. Mia is also an active member of MEDEC and RAPS and teaches Medical Device and Regulatory Affairs courses for the American Association of Pharmaceutical Scientists (AAPS). Mia was born in Montreal, is Lean Six Sigma trained, and has her degree in Chemistry and her post-diploma in Pharmaceutical Regulatory Affairs and Quality Operations.
Who Should Attend:
This two-day course is valuable for foreign manufacturers, local manufacturers, importers and distributors and new medical device companies in Canada. It is also valuable for new RA or QA people starting in a medical device company, and Pharma professionals considering new opportunities in medical devices RA or QA. This course is also a good refresher for those professionals who are in a medical device company or regulatory body and desire a better understanding of the “whole” medical device picture in Canada. ***PSG reserves the right to modify the material or instructors without notice or cancel an event. If the event must be cancelled, registrants will be notified as soon as possible and will receive a full refund of fees paid. PSG cannot be responsible for discount airfare penalties or other costs incurred due to a cancellation.

Health Canada/Santé Canada • U.S. Pharmacopeia (USP)
Canadian Association of Professional Regulatory Affairs/Association canadienne des professionnels en réglementation (CAPRA/ACPR)