Cold Chain Cold Chain in Canada eBook: 2014 | Page 15

Ridge, Boland & Associates McKesson Chief Compliance Officer Maryann is a former FDA Investigator with over 20 years of industry experience in Quality Assurance and Regulatory Compliance. She has worked for several major branded and generic manufacturers, and has served as an Adjunct Professor teaching graduate level courses in Quality Assurance/ Regulatory Affairs for the Temple University School of Pharmacy. She is also the coauthor of several industry guidance reports/publications. At the Summit > Workshop D: Interactive Audit Training & Fundamentals of Quality Systems 2:30 PM – Tuesday, February 25th 15 Director of Regulatory Affairs GMP, Officer Claude is Director, Regulatory Affairs, situated in the Montréal office. In this role Claude develops Regulatory Strategic Plan for compliance to all applicable regulations for the distribution of products, including but not limited to drugs, medical devices, narcotics and precursors. In his role he also coordinate actions as primary contact between McKesson Canada’s and Health Canada, helps in the interpretation of the numerous regulations, responds to proposed amendments to GMPs or other regulations and is involved in a number of committees pertaining to regulatory affairs. At the Summit > CRT/Ambient Compliance Through the Last Mile Including a pharmacy’s perspective on non-controlled drugs 2:00 PM – Wednesday, February 26th