Cannabis Extraction

• Review and develop ongoing quality assurance protocols and best practices.• Thoroughly review of the Canadian Cannabis Act and its Regulations.• In-depth review of GMP and GPP that will be implemented at the premises.• Create/review of Standard Operating Procedures, Forms and Labels (over 200 documents) to ensure compliance with the Cannabis Regulations.• Review of all processing activities that will be carried out as per existing Standard Operating Procedures.• Reviewed… Show more • Review and develop ongoing quality assurance protocols and best practices.• Thoroughly review of the Canadian Cannabis Act and its Regulations.• In-depth review of GMP and GPP that will be implemented at the premises.• Create/review of Standard Operating Procedures, Forms and Labels (over 200 documents) to ensure compliance with the Cannabis Regulations.• Review of all processing activities that will be carried out as per existing Standard Operating Procedures.• Reviewed all technical documents (including SOPs) to ensure they are conformed to the new Cannabis Regulations. • Ensure Standard Operating Procedures (SOP) will be controlled and secured in accordance with Good Documentation Practices.• Participate to different WebEx sessions hosted by Health Canada (HC) related to the Cannabis Industry.• Review of the company’s Licence Application prepared from the Cannabis Tracking and Licensing System.• Assist with any Request for More Information (RMI) from the Controlled Substances and Cannabis Branch related to CBD Medicinal Solutions’ application submitted under the Cannabis Regulations (CR) to become a cannabis license holder. • Review of Canadian Cannabis Licensing Application Guide, Good Production Practices Guide for Cannabis and the Physical Security Measures Guide for Cannabis.• Provided Health Canada with complete set of documents for Personal Security Clearance.• Worked with consultants to modify existing building floors plan to meet EU-GMP Standards. • Create flow charts for all processing activities that will be carried out.• Review latest amendments (10/17/19) to the Cannabis Regulations. Show less

• Implement regulatory processes, develop and execute regulatory strategies in line with corporate objectives. • Compile high quality submission documents in e-CTD format for product homologations in compliance with Health Canada’s regulatory standards, guidance and policies.• Develop professional relationships with regulatory agencies to help ensure organization adheres to laws and regulations, and receive proper guidance for right the first time submissions.• Communicate with… Show more • Implement regulatory processes, develop and execute regulatory strategies in line with corporate objectives. • Compile high quality submission documents in e-CTD format for product homologations in compliance with Health Canada’s regulatory standards, guidance and policies.• Develop professional relationships with regulatory agencies to help ensure organization adheres to laws and regulations, and receive proper guidance for right the first time submissions.• Communicate with regulatory agencies regarding pre-submission strategies, potential regulatory pathways, compliance test requirements, or clarification and follow-up of submissions under review.• Prepare, translate and/or review products labeling and promotional materials for compliance with applicable local, Provincial and Federal regulations and policies.• Liaise with key stakeholders and to the Global Regulatory Teams as required, in order to collect accurate and timely responses to Health Canada.• Regulatory risk assessment of on-going and future projects.• Represent Regulatory Affairs on cross-functional project teams and provide regulatory advice.• Maintain current knowledge base of existing and emerging Health Canada regulations, standards, policy and guidelines and share information with departments as required.• Prepare or maintain regulatory technical files, spreadsheets and electronic databases to obtain and sustain product approval and license/certificate renewals.• Register and maintain the homologation of 125 microbicides with the Pest Management Regulatory Agency – Health Canada.• Obtain many Letters of No Objection from the Bureau of Chemical Safety, Food Directorate, and the Canadian Food Inspection Agency, for sanitizers, disinfectants, and other products in contact with food.• Obtain registration approvals of products with the Feed Division – Health Canada. • Hire, supervise, train and mentor 20 direct reports in laboratory and regulatory departments. Show less

• Quality control of manufactured products and various analyses performed in an ISO certified environment.• Review of Certificate of Analysis/batch/packaging to assure all regulatory and internal requirements for the product quality, and processed to product release.• Followed Stability program / studies.• Update and maintenance of all Quality documentation logs.• Participate in Quality Complaint: coordinate all activities related to products complaint, forward them to all… Show more • Quality control of manufactured products and various analyses performed in an ISO certified environment.• Review of Certificate of Analysis/batch/packaging to assure all regulatory and internal requirements for the product quality, and processed to product release.• Followed Stability program / studies.• Update and maintenance of all Quality documentation logs.• Participate in Quality Complaint: coordinate all activities related to products complaint, forward them to all parties involved in investigation, maintain logs, and prepare reports and closure letter to customers.• Participate in Standard Operating Procedures (SOP) review to ensure compliance to regulations and laws. Show less