Salvador Funcion, MBA, CheEng, was until recently the Quality Assurance Manager for regulatory affairs at Niagara Pharmaceuticals.Salvador is an auditor, regulatory coach, consultant and instructor for global matters pertaining to pharmaceutical regulatory affairs, regulatory compliance, quality and clinical affairs. He obtained his Chemical Engineering and MBA from De La Salle University and is a certified quality auditor (CQA) by the American Society for Quality (ASQ).
He has spent 15 years working for pharmaceutical and medical gas companies manufacturing medical drugs and medical devices.He is an expert in pharmaceutical regulatory and quality compliance. He has a broad background and a crucial leadership role in functional areas, such as API product development/manufacturing, business process optimization, quality compliance, clinical development, and regulatory strategy. He also has hands on experience with global regulatory management and submission.
Prior to founding his own consulting firm (QAFM Services), he was the Quality Assurance Manager and Regulatory Affairs at BOC Canada, Limited in Toronto, wherein he provided inspiring and actionable solutions for sustainable business operation in the manufacture of medical drugs and medical devices gases. He provides practical, actionable and strategic solutions integrated with equipment validations, QE/QA/QC guidance, systems design and implementations in compliance to ISO 13485, GMP, GCP standards, CAPA, FMEA and auditing. Over the years, he has assisted several pharmaceutical clients to analyze and come up with solutions for their Health Canada and US FDA inspection 483s. He is familiar with more than 100 medical products (medical devices including IVD products, biologics, drugs and combination products). He provides directions for regulatory strategy, regulatory submission, clinical studies, and CMC requirements for different development stages, product indications, and labeling.
He has experience working with the US, Canadian and Southeast Asian regulatory regulations. He co-authored the IDRAC®, a complete pharmaceutical regulatory intelligence solution from Thomson Reuters that provides regulatory professionals with a one-stop source of information across the globe. Being a Certified Quality Auditor by ASQ, Salvador has more than 3 years experience performing ISO and GCP Clinical Trial Audits to a number of CROs in Ontario. Salvador currently teaches quality assurance, regulatory affairs and GCP compliance for North American Institute of Pharmaceutical Technology (NAIPT) in Toronto, Canada.