Marc Monette

  PhotoMarc Monette is a Subject Matter Expert (SME) on Computerized System Validation (CSV), System Life Cycle (SLC) processes and on the development of risk based and scalable validation programs that facilitate right-sizing the validation effort. Monette is a competent trainer who addresses hundreds of men and women each year on System Life Cycle (SLC) modeling, CSV and SLC program development, audit effectiveness, remediation planning and execution, and cost of quality. Monette has acquired over 2 decades of experience in pharmaceutical, biotechnology, medical device, and other regulated industries. Monette has traveled in the US, Canada, Europe and Asia consulting with large and small organizations, educating, and training professionals from many life sciences organizations. Monette is an American Society for Quality Certified Software Quality Engineer, Certified Quality Auditor, and Certified Quality Manager. Monette initiated his lifelong learning habits by achieving a BESc degree from the University of Western Ontario, an MBA degree from University of Toronto, and is currently working on his thesis to complete the Master of Science Regulatory Affairs (MSRA) degree at San Diego State University. As a consultant and an employee, Monette has drawn on the expertise of many others in the field and has taught many industry professionals the keys to success in this dynamic and exciting field.