TRAINING → AUDIT READINESS → INSPECTIONS

Steven is an experienced leader, facilitator and professor with approaching three-decades of expertise in guiding complex organizations through regulatory compliance and quality assurance excellence. Skilled in collaborating across all levels, including executive teams, and specializing in tailored solutions for quality, compliance, and training. Working with diverse sectors such as bio/pharmaceutical, biotech, medical devices, and natural health.

Expertise in GMP/cGMP, GCP, GLP, and regulatory compliance across multiple regions, including Health Canada, US FDA, Brazil ANVISA, EU EMEA, and UK MHRA. Proven success in designing and managing internal regulatory systems, leading inspections, conducting audits, and facilitating  collaborative learning experiences that connect worldwide professionals across borders.

Steven is also a Health Canada-approved and Security Cleared Quality Assurance Person (QAP). 

Dr. Swardfager has over 20 years of experience, including roles as an Associate Professor and Associate Chair of Pharmacology & Toxicology at the University of Toronto and as a Scientist at the Sunnybrook Research Institute, and he also holds a Tier 2 Canada Research Chair. His research program and laboratories integrate the principles of Good Clinical Practices (GCP), Quality Control (QC), and Quality Assurance (QA) to ensure the highest standards of clinical research integrity, participant safety, and data reliability, and his experience includes leading multidisciplinary teams that apply rigorous QC and QA frameworks to support robust standardisation, reproducible biomarker measurement, imaging analyses, and longitudinal participant follow-up. His research contributions have been recognised through numerous distinctions, including an Academic Gold Medal from the Office of the Governor General of Canada and two international New Investigator Awards, and his commitment to education and mentorship has also been acknowledged with two teaching awards from the Temerty Faculty of Medicine at the University of Toronto. 

Sanj is a senior pharmaceutical leader with over three-decades of industry experience, including Director-level and senior management roles across major pharmaceutical companies and CROs in Canada, the UK, and the US. Extensive expertise spanning bioanalytical and clinical research, clinical data oversight, protocol development and review, and analytical method development, validation, and transfer. Deep experience across Quality Control and Quality Assurance, with end-to-end leadership of GCP/GLP/GMP compliance, audit readiness, regulatory inspections, and quality systems. A proven leader in operations, cross-functional program delivery, and complex project management. 

Michelle is an experienced pharmacist with a strong record of practice across clinical healthcare and retail settings, recognized for delivering high-quality, patient-centered care. She holds a Bachelor of Science (B.Sc.) in Pharmacy from the University of Toronto and has been a Certified Diabetes Educator (CDE) since 2000, providing more than two-decades of specialized education, training, and clinical consultation. Throughout her career, Michelle has integrated Quality Assurance (QA) and Quality Control (QC) principles to enhance drug safety, strengthen clinical workflows, and ensure accuracy in medication-related documentation, while applying Good Clinical Practice (GCP) standards to maintain ethical, consistent, and high-integrity care. She continues to contribute meaningfully to patient wellness, interdisciplinary collaboration, and the advancement of pharmacy practice and clinical quality systems.