James A. Rudland, B.Sc.
Executive Technical Director

Mr. Rudland is the Executive Technical Director of the Aries Communications Group Inc., a company focused on the production of strategic communications in the science, medicine, corporate, and educational arenas. Aries has its own production studio and post-production facilities located in Markham Ontario. The company has successfully produced technical communications for companies in North and South America, Europe and Australia.

Mr. Rudland has 30 years of previous experience in quality assurance and manufacturing in both the pharmaceutical and medical device industries in the United States and Canada. He has worked extensively in the areas of sterile parenteral production and environmental control and monitoring. He has also held positions in international and domestic regulatory affairs at the senior vice president level.

In 1985, Mr. Rudland was responsible for the implementation and validation of the first high speed automatic particulate inspection equipment for use in the Canadian parenteral production market.

As a consultant, Mr. Rudland has authored guidance documents, trained plant core team leaders and has provided technical guidance to successfully redesign master batch documentation at various plants in North America. He is now involved in the development of unit operation based training materials proven to be effective in reducing costs associated with non-compliance as a result of employee misunderstanding.

Mr. Rudland has managed the preparation and negotiation for approval of NDSs, SNDSs, ANDs, and DINs with Canadian and US federal regulatory agencies and has secured regulatory approval for more than 50 products manufactured in the US and Canada. He has successfully facilitated associated FDA inspections at various sites in Canada and has conducted third party cGMP quality audits in Canada, US and Mexico.

Mr. Rudland holds a diploma in Immunohematology from The Toronto Institute of Medical Technology and an Honours Bachelor’s degree in biochemistry from York University in Toronto. 

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