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This comprehensive resource covers product change evaluation, postmarket surveillance, audit/inspection compliance, and various other laws and regulations pertaining to maintaining a product on the market.
Hear from leaders around the globe as they share insights about their experiences and lessons learned throughout their certification journey.
Item Details:
This is a compilation of two books RAPS published in 2018: Fundamentals of Canadian Pharmaceutical and Biologics Regulations and Fundamentals of Canadian Medical Device Regulations.
It is the result of a collaboration among RAPS, officials from Health Canada and the Canadian Association of Professionals in Regulatory Affairs (CAPRA), and presents the current Canadian regulatory environment for pharmaceutical and biologic products, medical devices and in vitro diagnostics.
Among the topics covered:
A comprehensive index for each section is included.
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