Ewan DeSilva
Principal Consultant

Profile

Consultant with Health Canada CTLS security clearance, coupled with over 20 years of industry experience, Ewan DeSilva has been instrumental in the successful growth and market development for multiple  organizations in various industries: Cannabis, Pharmaceutical, Biotech, Environmental, and Academic.

 

Recent roles included Director of Quality Assurance and Director of Analytical Laboratories within the Cannabis space.

 

QUALITY ASSURANCE

 

Responsible for all aspects of quality within the organization from seed to sale, including review and approval for all documentation including:

 

  • Batch Records and Release

  • OOS Investigations

  • CAPA and Change Controls

  • Inspections and Audits (Internal and external)

  • SOPs

  • Protocols and Validations

  • Third party testing results in interpretation and review

  • Environmental Monitoring

  • Security design, planning, incidents, organizational security plan (OSP)

  • Loss/Theft

  • Sanitation and Pest Control

  • Training Modules and Programs for Good Documentation Practices

  • Preparation for regulatory inspections – Health Canada/FDA/EU/ISO

  • Preparation and Maintenance of accreditations

  • GMP/GPP/GDP

 

ANALYTICAL LABORATORY

Responsible for all aspects of the laboratory including:

 

  • Design, Plan, PM the build-out

  • Health and Safety, WHMIS, and WSIB

  • Former Certified JHSC member – worker and management

  • Source all instrumentation

  • Method Development and Validation as per ICH and ISO 17025

  • Installation Qualification (IQ) and Operational Qualification (OQ)

  • Troubleshooting

  • Review of all test results

  • Certificate of Analysis

  • OOS Investigations

  • SOP’s, Protocols, Reports

  • Technical Resource for Sales and Marketing

  • Pharmaceutical Compendial Methods – USP, BP, EP, JP

  • Sample Preparation for various matrices

  • Formulation development for topicals and edibles including chocolates, biscuits, cookies, gummies, candies, vapes, lotions, creams, ointments

 

CANNABIS METHODS OF ANALYSIS

Health Canada Methods (Hands-on development and validation):

 

  • Cannabinoids

  • Pesticides

  • Terpenes

  • Residual Solvents

  • Mycotoxins/ Aflatoxins

  • Metals

  • Microbial Enumeration (review)

 

ANAYLTICAL INSTRUMENTATION

Hands-on Expertise for Usage, Calibration, Qualification Maintenance, Repair:

 

  • LC/MS/MS (ESI/APCI/Nanospray)

  • GC/MS

  • GC/FID/Headspace

  • ICP/MS

  • Dissolution USP 1,2, and 4

  • Disintegration

  • Moisture by Karl Fisher (Coulometric/Volumetric)

  • Physical Testing

  • Other Pharmaceutical equipment

 

SOFTWARE

 

  • Design, development, and implementation of LIMS, QMS, Inventory

  • Tracking, Seed-to-sale software

  • Creation of in-house databases for cost-effective tracking

  • Technical resource testing third-party LAB/QMS software packages

 

BUSINESS DEVELOPMENT AND OTHER SKILLS

 

  • SRED examination, evaluation, and write-up for tax reimbursements

  • Representation as a technical resource at tradeshows/conferences

  • Technical consultant for construction projects for laboratory builds

Inquiries welcomed and appreciated

647.984.3141

ewan@exdconsultinginc.com

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