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Medtech Innovation Basics: Regulatory Plan & Quality Management Systems

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Sunnybrook Health Sciences Centre

2075 Bayview Avenue

Lecture Theatre M6-502

Toronto, ON M4N 3M5

Canada

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Speaker: Alan Coley, President, Coley Consulting Inc.

Alan Coley has earned a reputation as a respected Regulatory/Quality Assurance Executive with experience in both established and early-stage pharmaceutical and biotechnology companies. Alan is a graduate pharmacist with more than 25 years of senior management experience in international Regulatory and Quality positions and has been successful in guiding first-in-class submissions with the FDA, Health Canada and regulators in Europe. Alan has been the management representative, implementing ISO 13485 Quality Systems and taking a lead role in audits from FDA, Canadian and international regulatory authorities and several suppliers. He has sat on many committees providing feedback and industry perspectives to the FDA and Health Canada in recent years these committees have focused on Software as a Medical Device. Following a successful career in industry, Alan started his own consulting company, Coley Consulting Inc which specializes in Regulatory and Quality Assurance support to the Pharmaceutical and Medical Device industry.

Abstract: This lecture provides an overview on medical device regulation and quality management systems. Key learning objectives of this lecture include: (i) Understanding the role of quality systems and process management in the process of medical device innovation and commercialization; (ii) recognizing the key components of quality systems and their strategic importance to managing a business; and (iii) understanding quality-related regulatory requirements.

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Date and Time

Location

Sunnybrook Health Sciences Centre

2075 Bayview Avenue

Lecture Theatre M6-502

Toronto, ON M4N 3M5

Canada

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