Regulatory and QA Consultant
Medical Devices, Pharman, NHP
KEY SKILLS

Quality Management System (QMS)

Internal Audits and Vendor Audits

MDSAP audits (Health Canada)

Training of Quality team (cGMP, ISO 13485,

ISO 15189, GMP, GCLP, Canadian MDR)

Medical Device technical submissions

Health Canada Class II/III/IV applications for

Medical Device License (MDL)/Medical Device

Establishment License (MDEL)

Responding to non-conformances, CAPA

SECTOR EXPERTISE
Medical Devices
Lab Diagnostics Devices
Biotechnology
Pharmaceuticals 
Natural Health Products
cGMP Manufacturing

Geihan (Gigi) Rizkalla is seasoned certified professional in regulatory and quality management systems, with over 25 years of experience serving the medical device, pharmaceutical and natural health product (NHP) sectors. Her skills include assessment, initial setup and development, management and conducting audits of quality management systems that are compliant to the following regulations:  US FDA 21 CFR 210, 211 and 820, Canadian Medical Device Regulations, ISO 9001, ISO 13485, MDSAP, ISO 15189, European MDD & IVDD and the new EU MDR and IVDR. Gigi has gained a reputable body of experience in regulatory and quality assurance affairs from hands-on industry experience as a Senior Research Associate at Allelix Biopharmaceuticals, as QC/QA Manager at TM Bioscience Corp. (now Luminex Molecular Diagnostics Inc.), and as Director of Quality Assurance & Quality Control at SQI Diagnostic Systems Inc. In 2011, she established her independent practice as Principal Consultant at G.R. Quality Consulting Inc., supporting a wide range of corporate clients that comprise multinationals (Perkin Elmer, Meditech International), SMEs (RNA Diagnostics, Genzyme Canada, Fio Corp.) and several early-stage startups. Gigi has enabled companies to go-to-market by drafting their regulatory and QMS document submissions, by developing Quality Metrics for measuring key performance indicators, and by providing hands-on training of employees in QMS and GMP requirements.

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