John Simon Email & Phone Number

Edmonton

- Quality Assurance Management services for a Biotechnology company.- Involved with the validation series for the manufacturing of a fast track drug.- Quality Assurance Consulting services provided to support process validation; consistency series manufacturing; and Pre-Approval Inspection (PAI) preparation. Preparation activities for both FDA and European Union inspections.- On-site support for inspections.- Economic Diversification.- Commercial Production batch record review.- Review and assessment of deviations, CAPA and Change Control.- Failure investigations of Manufacturing Facilities.- SOP writing (Deviation Management, Change Control, Auditing)- Vendor qualification audits.- Clinical Trial protocol writing and review to assure compliance to ICH E6.- Clinical Trial Applications, CTA and IDE.- For cause audits and associated CAPA review.- Technology Transfer.- Product License Applications.- Site License Applications.- Health Canada audit preparation and audits.- New product development.- Regulatory research and classification.- Investigational Testing Authorizations.- Pre-Meetings withthe FDA and Health Canada- Marihuana for Medical Purposes - MMPR- Marijuana Quality Assurance Pre-Licensing Report- Quality Assurance Reports for MMPR Licenses- MMPR Application Section 10- Quality Assurance Support for Division 4 and 5 of the Marijuana for Medical Purposes Regulations- 3rd party release verification- Third party release verification- CEO GrenEx Pharms Inc. (May 2015 to Jan 2018)- Partner at QnR Associates- CEO at Pebble Grass Inc.

Edmonton, Canada Area

Support of the application process and mentoring of a Quality Assurance Person to support Marihuana for Medical Purposes production:Section 10 of the application form: QUALITY ASSURANCE PRE-LICENSING REPORT• As per paragraph 23(4)(h) of the MMPR, a document, signed and dated by the proposed quality assurance person required in section 60 of the MMPR, must be included that details the quality assurance person's qualifications and establishes that the buildings, equipment and sanitation program comply with the requirements of Division 4. Please ensure that the quality assurance person signs and dates this document to complete this portion of the application.• As per subparagraph 23(4)(h)(ii) of the MMPR, you are required to submit a complete Quality Assurance report establishing that the building(s), equipment and sanitation program comply with the requirements of Division 4. You must include a description in your Quality Assurance report that the building(s), equipment and sanitation program used at your site will be in compliance with sections 55, 56 and 57 of Division 4 ofthe MMPR.• For more information on quality assurance compliance and what must be included in your Quality Assurance Pre-Licensing Report please refer to Division 4 (sections 52-63) of the MMPR and the Technical Specifications for Testing Dried Marihuana/or Medical Purposes guidance document found online at: http://www.hc-sc.gc.ca/dhp-mps/marihuana/info/add­ supp-eng.phpMMPR Quality Assurance Person for production operations.MarijuanaMarihuanaCannabis Projects to diversify the economy.

Alberta, Canada

Edmonton, Canada Area

http://www.tecedmonton.com/BusinessDevelopment/RegulatoryGuidance/tabid/437/language/en-US/Default.aspx

Edmonton, Canada Area

CEO to guide the establishment of a medical cannabis production facility. First Licensed facility in Edmonton.

Edmonton, Canada Area

Edmonton, Canada Area

- Head of Quality Assurance

Edmonton, Canada Area

Formerly Alberta Cancer Board, Cross Cancer Institute, currently Alberta Health Services. Audits of Clinical Trials to verify data integrity and assure compliance with Good Clinical Practice.

Later became Oncotheryon.

Later became a division of EMD Serono

Later acquired by Haemonetics.

Millwoods

Formerly Alberta Research Conucil. Duties included the Quality Control of the large-scale fermentation facility at The Alberta Research Council. Other duties included the evaluation and validation of quality control assays used in the lab.

Formerly SynPhar Laboratories Inc. Duties included microbiological testing of potential commercial drugs for the treatment of infectious diseases. The screening and evaluation of novel antibiotics led to the identification of possible lead compounds selected for further characterization. Responsibilities included performing experiments and reporting the results during monthly project meetings.

Bsc, Biological Sciences

Activities and Societies: Played soccer with the Bears for 5 seasons from 1986 to 1990.

Education record