I have a B.Sc. from the University of Alberta, am 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. I have held a series of management positions in Quality Assurance and Regulatory Affairs and also work as a consultant.
I have had a variety of experience being directly involved in FDA and Health Canada Audits in the areas of Medical Device Manufacturing, Drug Manufacturing and Testing, Drug and Device Establishments and Clinical Trial sites. Over the years I have gained experience with biologics, pharmaceuticals, medical devices, dietary supplements/natural health products and cosmetic ingredients. I have experience with a number of submissions to Health Canada and the FDA.
Senior Member – ASQ
Regulatory Affairs Certification – RAC
Registered Quality Assurance Professionals in Good Laboratory Practice – RQAP-GLP
For Quality Assurance in a batch production, the person "to go" and "to learn from" is definitely John. Such detail oriented skill is essential for industries.
John is a conscientious and thorough worker. He maintains a big picture view of the needs of the company and is able to implement quality improvement processes to ensure regulatory requirements are met. He is a pleasure to work with, has a great sense of humour, and is a fabulous team player. John is attuned to the needs of each team member and facilitates good communication and collaboration.
John Simon and Associates Ltd.