John has a Bachelor of Science from the University of Alberta, is a senior member of the American Society for Quality, a Certified Quality Auditor (CQA), a Registered Quality Assurance Professional in Good Laboratory Practice (RQAP-GLP) and maintains Regulatory Affairs Certification (RAC) through the Regulatory Affairs Professional Society.
John has held various management positions in Quality Assurance and Regulatory Affairs and has worked as a consultant supporting clients in the medical device, pharmaceutical, biotechnology and natural health product industries since 2004. He has been directly involved in Federal Drug Administration (FDA) and Health Canada audits of medical device manufacturers, drug manufacturers, testing facilities, and clinical sites. He has experience with submissions to the FDA and Health Canada.
Through John’s consultancy practice he assists companies with both site licenses and product licenses. He has helped companies obtain, renew and maintain in good standing Drug Establishment Licenses (DEL); Medical Device Establishment Licenses (MDEL); Natural and Non-prescription Site Licenses (NNHPD); and Licenses to Cultivate and Distribute under the Marihuana for Medical Purposes Regulations (MMPR) (now under the ACMPR).
John also works in creating quality systems to support ISO certification for various clients (ISO 17025, ISO 13485 and ISO 9001). John consults to groups in the creation of specifications, batch records and procedures to support the design and development of a variety of products including cosmetics, natural health products, medical devices, biologics, pharmaceuticals and controlled substances.
“With John’s substantial background in QA and regulatory affairs specific to drug development and the cannabis industry he will be a key asset in driving our cannabis product and technology initiatives,” said Mr.Kent Deuters, CEO of MJ Biopharma.
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Vinergy Resources Ltd.
Glen Macdonald, Director
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