Areas of expertise: Quality Assurance, Regulatory Affairs, FDA and Health Canada Submissions, Medical Device and Drug Manufacturing Audits, Cannabis Cultivation and Processing.
Current role: Principal Consultant, John Simon & Associates Ltd.
Mr. Simon is a Senior Member of the American Society for Quality, Certified Quality Auditor (CQA) through the American Society for Quality; Regulatory Affairs Certification (RAC) through the Regulatory Affairs Professional Society; and RQAP-GLP certification through the Society of Quality Assurance. He has extensive experience with submissions to the FDA and Health Canada as well as audits in the areas of medical device manufacturing, drug and device establishments and clinical trial sites – notably, he has helped companies with Section 10 of the application to produce medical cannabis as well as setting up the process control and documentation requirements for controlled substance manufacturing. Other certifications include ISO 13485_: 2016 Certificates in AU – Management Systems Auditing v2.0; MD – Medical Devices Quality Management Systems v2.0; and TL – Leading Management Systems Audit Teams v2.0.