Caroline Mills

Independent Regulatory and Quality Compliance Consultant @Health Canada Santé Canada

QA/GMP Consulting for pharmaceuticals, biologics, natural health products, medical marijuana, and medical devices. Specialist in Audits for all industries- Contact person for Health Canada GMP Audits on behalf of clients to ensure maintenance of DEL - Conducted GMP Audits as part of self-inspection requirements for clients in the US and Canada -Quality Control review and release of products for sale in Canada, and coordination of testing - Completed Drug Establishment Licences and Renewals, Medical Device Licences and Site Licences for clients - Ensured complete GMP Compliance for clients including writing complete SOP, Quality Manuals, Work Instructions and ensured all regulatory requirements were met - Assisted companies in reversing Health Canada decisions to revoke Drug Establishment Licences (100% success rate)- Conducted GMP Training on behalf of clients - Performed Due Diligence on target pharmaceutical operations in terms of GMP prior to corporate acquisitions - Audited and Monitored Clinical Trials providing regulatory guidance to clinical trial sponsors and investigators, was a previous Health Canada auditor of Clinical Trials ensuring compliance with Division 5, Can assist Clinical Trials compliance with GCPs - Ensured pharmacovigilance programs for clients met regulatory requirements - Assisted and evaluated clients with respect to resolution of CAPAs to ensure compliance - Security Clearance obtained with the CTLS program of marijuana in Canada - Director of Quality for a Licensed Producer with the Marijuana program, was able to successfully complete 4 Health Canada Audits and received the License to Produce and License to Sell, Implemented the Quality Program at the facility and achieve compliance