2025
Distinguished speakers & panelists
MAGDA JOSEPH, B.Eng.
Regional Manager, GMP Inspections – East | La Gestionnaire Régionale de l’unité des inspections BPF – Est
Regulatory Operations and Enforcement Branch |Direction générale des opérations réglementaires et de l’application
Health Canada / Government of Canada |Santé Canada / Gouvernement du Canada
Magda Joseph is the Regional Manager of the GMP Inspections – East unit within the Regulatory Operations and Enforcement Branch (ROEB) at Health Canada. In this role, she leads the enforcement of the Good Manufacturing Practices (GMP) inspection program, ensuring that drug products and related activities comply with current regulations and guidelines. She oversees both domestic and international inspections of pharmaceutical sites, as well as paper-based evaluations of risk files and assessments conducted by regional inspectors. Her work supports Health Canada’s core mandate of delivering effective compliance and enforcement activities.
Magda is actively involved in international initiatives aimed at fostering collaboration, enhancing regulatory alignment and harmonization, and promoting reliance among global regulatory partners.
Before joining Health Canada 14 years ago, Magda spent a decade in the pharmaceutical and pre-clinical industry, holding roles in compliance, quality assurance, and computer system validation.
Magda holds a Bachelor of Chemical Engineering from Polytechnique Montréal, the engineering school affiliated with the University of Montreal, with a specialization in Processes and Biotechnology.
Magda Joseph est la Gestionnaire Régionale de l’unité des inspections BPF – Est au sein de la Direction générale des opérations réglementaires et de l’application de la loi (DGORAL) de Santé Canada. À ce titre, elle assure la gestion du programme d’inspection des Bonnes pratiques de fabrication (BPF), afin d’assurer que les produits pharmaceutiques et les activités connexes sont conformes aux règlements et lignes directrices en vigueur. Elle est responsable des inspections nationales et internationales des sites pharmaceutiques, ainsi que des évaluations de dossiers papier et des dossiers de risque réalisés par les inspecteurs régionaux. Son travail soutient le mandat principal de Santé Canada en matière de conformité et d’application de la loi.
Magda participe également à des initiatives internationales visant à favoriser la collaboration, à renforcer l’harmonisation et l’alignement réglementaire, et à promouvoir la confiance entre les partenaires réglementaires internationaux.
Avant de se joindre à Santé Canada il y a 14 ans, Magda a travaillé pendant dix ans dans l’industrie pharmaceutique et préclinique, occupant des postes en conformité, en assurance qualité et en validation des systèmes informatisés.
Elle est titulaire d’un baccalauréat en génie chimique de Polytechnique Montréal, l’école d’ingénierie affiliée à l’Université de Montréal, avec une spécialisation en procédés et biotechnologie.
Éric Desautels
Regional Regulatory Compliance and Enforcement Specialist, GMP Inspection – East / Spécialiste régional de conformité et d’application de la loi, Inspection BPF – Est
Health Canada / Government of Canada |Santé Canada / Gouvernement du Canada
Franklin Jean
A/ Regional Supervisor, GMP Inspection – East / Superviseur régional p.i, Inspection BPF – Est
Health Canada / Government of Canada |Santé Canada / Gouvernement du Canada
Dr. Ulrich Kissel
Chairman of the European QP Association.
Founder & owner, Kissel Pharma Consulting GmbH
Dr. Ulrich Kissel, pharmacist holding a Ph.D in biochemistry, worked for 23 years for the multinational Pharma company Roche in Quality and Supply Chain leadership positions. In 2017 Dr. Kissel established his consultancy company supporting small to large Pharma companies in various GMP compliance or Quality Control projects from the perspective of EU regulations. He is eligible Qualified Person (QP) for medicinal products according to EU laws for industry, acts as chairman of the European QP Association, and as director regulatory for the European Compliance Academy.
CONFERENCE CHAIR
NATASHA DEMBERG, BSc, MSc
President
Demberg Pharma Solutions
Natasha Demberg is the founder, owner, and principal consultant at Demberg PharmaSolutions – DPS (www.dembergsolutions.com) nominated in 2022 as one of the Top 10 Canada Life Science Consulting Companies by the Life Sciences Review.
Natasha has over 30 years of Quality, Compliance, Validation, and Operation leadership experience in large and small, commercial, and clinical life science companies. Natasha helped numerous companies in development and application of Quality Management Systems throughout the product life cycle, creation of Quality Unit, improvement of the existing and development the new processes and procedures, fully compliant to applicable regulations and, at the same time, harmonised with the operational and business needs. In addition, Natasha is specialized in vendor qualification and audits, PAI readiness, FDA and HC Mock Inspections, internal audits, and creation company culture oriented to Quality and Customer needs.
At Demberg PharmaSolutions we believe in the Partnership between Quality and Business, and we provide solutions to ensure Process Efficiency and Efficacy.
Natasha holds a BSc in Chemical Engineering, a MSc in Chemistry of Polymers, Six Sigma Green Belt Certification, and is a member of the Quebec Chapter of the Society of Chemists, L’Ordre des chimistes du Québec.
Natasha is an Industry Speaker on Quality and GMP Compliance in the Life Science Industry, program of Pharmaceutical Technology at John Abbott and various GMP conferences and seminars.
Conference Co-Chair
Alan Golden, MS
Principal
Design Quality Consultants, LLC
Alan has over 35 years of experience in the medical device industry, both in basic research and in quality assurance. Alan spent 31 years at Abbott Laboratories. For the first 16 years as part of diagnostics R&D, he developed recombinant proteins used in diagnostics tests, received three US patents and published numerous papers and abstracts. Alan then transitioned to a quality assurance role where in both the Abbott Diagnostics and Abbott Molecular divisions, he was responsible for quality assurance for new product development, on-market product support and operations.
Alan’s quality assurance experience extends from design control, change control, risk management, CAPA, process and test method validation and statistics. He has been lecturing on these topics worldwide for over 20 years.
Alan retired from Abbott in 2018 and now runs Design Quality Consultants, providing training, workshops and seminars in many areas of quality assurance.
Alan received his BS degree in Microbiology from the University of Michigan and his MS degree in Molecular Biology and Immunochemistry from the University of Illinois.
Carlo Candotti
IT Governance & System Lifecycle Advisor, Local Equity Partner,
PQE
Mathieu Fournier presently serves as Chief Scientific Officer at Neopharm Labs. This challenging role allows him to apply his global knowledge and expertise of analytical chemistry in the pharmaceutical industry to meet the evolving business demands of various customers from the life sciences industry.
Mathieu has over 25 years of experience in applied research & development within the pharmaceutical industry. Over the course of his career, he managed the development & validation of methods to support routine testing, risk assessments and various studies required for NDA/ANDA submissions and post-commercial support. He is also experienced in providing answers to health authorities as a subject matter expert for several types of dosage forms such as tablets & capsules, ophthalmic solutions and injectable products.
Mathieu’s speciality in mass spectrometry brought him to develop lines of analytical services to support technical issues related to elemental impurities, extractables & leachables and genotoxic impurities. In his current role he is expanding his ability for strategic implementation of new services to multiple fields of expertise, such as biopharmaceutical drug product testing.
Mathieu holds a Master of Science degree in Analytical Chemistry, specializing in small molecule analysis by LC/MS from the Université du Québec à Montréal (UQÀM).
Mathieu D. Fournier, M.Sc.
Chief Scientific Officer
Neopharm Labs
Mathieu Fournier presently serves as Chief Scientific Officer at Neopharm Labs. This challenging role allows him to apply his global knowledge and expertise of analytical chemistry in the pharmaceutical industry to meet the evolving business demands of various customers from the life sciences industry.
Mathieu has over 25 years of experience in applied research & development within the pharmaceutical industry. Over the course of his career, he managed the development & validation of methods to support routine testing, risk assessments and various studies required for NDA/ANDA submissions and post-commercial support. He is also experienced in providing answers to health authorities as a subject matter expert for several types of dosage forms such as tablets & capsules, ophthalmic solutions and injectable products.
Mathieu’s speciality in mass spectrometry brought him to develop lines of analytical services to support technical issues related to elemental impurities, extractables & leachables and genotoxic impurities. In his current role he is expanding his ability for strategic implementation of new services to multiple fields of expertise, such as biopharmaceutical drug product testing.
Mathieu holds a Master of Science degree in Analytical Chemistry, specializing in small molecule analysis by LC/MS from the Université du Québec à Montréal (UQÀM).
Parsa Famili
President and CEO
Novatek
Parsa Famili, Is the President and CEO of Novatek International. Prior to joining Novatek, he held senior management positions in quality departments of several North American pharmaceutical companies. He has participated and successfully completed several FDA, EMEA, TGA, and Health Canada audits. He was also an instructor of Chemistry and Biochemistry at Vanier College in Montreal. Mr. Famili has published chapters and articles in various industry journals and publications including contributing as an international speaker at industry events such as today’s IPA event! He is the recipient of King Charles III Coronation Medal, for his work at Hope for Dementia Charity with a mission to prevent Dementia and Alzheimer’s.
Elaine Gourlay, B.Sc.
President and Principal Consultant
GMP Consultants Inc.
Elaine brings over 30 years of experience in the pharmaceutical industry, having served in senior Quality and Compliance roles at organizations such as Wyeth, Jubilant DraxImage, and Green Cross Biotherapeutics. As the Founder, President, and Principal Consultant of GMP Consultants Inc.—established in 2016—she leads the company’s strategic direction, consultancy services, and client engagement, with a strong focus on Good Manufacturing Practices (GMP) and regulatory compliance.
Elaine and her team leverage their extensive expertise in GMP regulations to support a broad client base across Canada, the United States, and international markets, assisting them in achieving operational excellence.
The firm’s service offerings include GMP Compliance and System Implementation, Project Management, Risk Assessments, Data Integrity Assessments, Inspection Readiness, Supplier Audits and Qualification, Quality Agreements, Continuous Improvement of Quality Systems, and GMP Training.
For inquiries or to discuss your specific needs, please contact Elaine at https://gmpconsultants.ca/
Dr. Jorge G. Ganopolsky
Scientific Director, Life Sciences
Neopharm Labs
Jorge Ganopolsky serves as Scientific Director of Life Sciences at Neopharm Labs since 2023, in which he applies his broad experience to support both clients and laboratory personnel in the development of analytical solutions to characterize novel biological therapies including proteins, nucleic acids and cells.
Throughout his career of over 25 years, Jorge has focused on researching physicochemical properties of aqueous solutions at extreme conditions and later delved into coagulation, inflammation, and vascular biology in blood. His experience has been instrumental in various R&D projects within the biotech industry and clinical diagnostics, including the development of medical devices, potency assays for quality control of nutraceuticals, and companion diagnostics for patient care.
Driven by a passion for learning and innovation, Jorge is dedicated to advancing the biotechnology and pharmaceutical sectors in the Life Sciences laboratory at Neopharm, developing new services for the industry. Jorge has a wealth of expertise in the development and validation of analytical technologies in chemistry, biochemistry, molecular biology, cell-based assays, and preclinical models. Jorge holds a Ph.D. degree in Biochemistry from the University of Notre Dame, specializing in the study of blood coagulation and inflammation.
John M. Hyde, BS, BBA, MS
Founder and Principal
Hyde Emeritus LLC
John Hyde is a pharmaceutical engineering and regulatory compliance expert with over 40 years of experience designing and qualifying pharmaceutical manufacturing equipment systems for cGMP operations. Regulatory compliance experience includes manufacturing facility pre-inspection auditing and preparation, “back room” support during PAI and routine GMP inspections, and post inspection response report generation and remediation planning. He has specific and in-depth expertise in biopharmaceutical manufacturing systems, cleaning (CIP), and sterilization (SIP).
John is currently the Founder and Principal at Hyde Emeritus LLC, a consulting firm that provides expert services to pharma and biopharma manufacturers and legal entities, including engineering, and cGMP regulatory consulting and expert witness work. He also is the Founder and a Senior Principal at Hyde Engineering + Consulting, Inc., a boutique biopharmaceutical engineering firm focusing on process equipment design and integration for cGMP manufacturing facilities. John grew the firm from a staff of one to a headcount of over 250 engineers and scientists with offices in the US, Canada, Ireland, Germany, India, Singapore, and Maylasia. For twelve years prior to the start of Hyde Engineering + Consulting, Inc., John gained significant experience in process engineering and automation of pharmaceutical and biopharmaceutical cGMP manufacturing facilities as a Senior Project Engineer at Synergen, Inc. a biopharmaceutical manufacturing and research firm. And as a Process Engineer and Process Engineering Manager at Seiberling Associates, Inc. , an engineering firm specializing in design of process systems for the manufacture of biological based products.
John has presented numerous technical papers, at conferences hosted by International Pharmaceutical Academy, Pharma Conference, ISPE, PDA, ASME, AIChE, MicroRight, and PharmEd Resources, and he has published articles and book chapters on process engineering, CIP design and optimization, process automation, and regulatory compliance. He holds a Master of Science Degree in Food Engineering Science, a Bachelor of Science Degree in Food Science, and a Bachelor of Science Degree in Business Administration all from the Ohio State University.
Masha Ivankovic, ing./eng.,
Présidente / President
Monbel Consultants Inc.
Masa Ivankovic has over fifteen years of experience in the pharmaceutical and biotechnology industries. Having started her career in injectables, she then worked in consulting before founding her own engineering consulting firm in 2018. Her work covers a wide range of engineering, project management and quality mandates in the life sciences industries. Masa holds a Bachelor of Science from McGill University, a Bachelor of Chemical Engineering from École Polytechnique de Montréal and an MBA from McGill University. She is a member in good standing of the Ordre des ingénieurs du Québec.
STUART DU KAMP, BSC (HONS), CCHEM MRSC, PCHEM
President and Founder
The Quality Consortium
Stuart du Kamp is the President and Founder of The Quality Consortium, a full-service quality consultancy based in Ontario, Canada. As a veteran of the pharmaceutical industry (thirty-seven years), Stuart has established a reputation as a dynamic quality leader with a demonstrated history of driving companies to success, especially during periods of transition and change. He began his career at the bench as an analytical chemist, and for the last twenty-eight years has held roles in Quality Leadership, including twelve years within CMO organizations.
Stuart is a quality systems builder with a reputation for bringing transformational change to organizations. He is also an ‘ideas’ guy and innovator who thrives in environments that demand pragmatic, cost effective and timely solutions to complex problems.
Stuart holds a bachelor’s degree in ‘Chemistry and Analytical Science’ from Loughborough University, UK, and is certified as both a Chartered Chemist (UK) and a Professional Chemist (Canada). Stuart’s previous companies include SmithKline Beecham, Raylo Chemicals, QSV Biologics, Septodont, TPIreg, and Innomar Strategies (Cencora).
Hank Karayan, BSc, MBA
Global Head of Cosmetics & Pharma Assurance
SGS
Hank Karayan is the Global Head of Cosmetics and Pharma Assurance at SGS. He started his career as a quality, GMP, food safety and cosmetics consultant and trainer for a European multinational consulting firm, acquiring his hands-on experience in strategic management, industry regulations, best practices and Total Quality Management. He has led multiple projects since then for multinational firms, SMEs and regulatory bodies in various geographies. He then moved to the world of audit and compliance, to specialize in supply chain risks, food safety strategies, food defense, information security and management systems. He holds a Bachelor of Science degree in Biology and Master of Business Administration (MBA), and has many publications in food safety, food defense, FSMA and strategic management.
Michael Lee, BSc
Director, QA GMP
Cencora, Innomar Strategies
Michael Lee brings over 20 years’ experience in the Pharmaceutical and Food Industry, specifically, managing Food, Drug, Natural Health Product and Narcotic and Controlled Substance Regulations. He has extensive experience operating in GMP Manufacturing Environments in quality management and operations. He has a BSc in biology and is experienced in Integrated Lean 6 Sigma methodology. He uses is expertise to improve and streamline process ensuring quality and business needs are met. He offers a practical approach to development and implementation of Quality Systems that are efficient, scalable, and sustainable. Prior to working with Innomar he worked for Apotex and Mondelez Inc.
Dr. Willis H. Thomas, PMP, CPT
PQE US
Dr. Willis H. Thomas, PMP, CPT, is a seasoned expert in Project Management and Performance Technology, with over two decades of impactful work in Human Resources and Training across the life sciences sector. Since 2003, he has contributed to critical functions spanning Drug Product (DP) and Active Pharmaceutical Ingredient (API) manufacturing in Kalamazoo, MI; Quality Assurance for Vaccines R&D in Pearl River, NY; Pharmacy Benefits Management in Irving, TX; Clinical Research in Arlington, VA; and both generics and branded pharmaceuticals in Lake Forest, IL. His current role involves consultancy in life sciences on an international basis.
Since 2019, Dr. Thomas has extended his professional experience, serving as a business strategist, adjunct professor and guest speaker engaged in global initiatives aimed at elevating compliance, performance, and innovation. He has been featured on International Project Management Day and traveled abroad since 2005 as a conference speaker for organizations such as IVT Informa.
An active contributor to thought leadership in his field and editorial advisory board member, Willis regularly publishes in academic journals, blogs, and newspapers, and is a frequent speaker at pharmaceutical and life sciences conferences worldwide. His expertise spans a wide range of topics including:
- Project Management
- Quality and Compliance
- Human Resource Development
- Evaluation, Research and Measurement
- Learning and Development
- Information Technology
Willis has successfully deployed leading learning management systems, such as ComplianceWire, SumTotal, ISOTrain, Plateau, OnTrack Online, and Registrar—transforming training infrastructures to support robust centers of excellence for training.
A passionate advocate of Project Evaluation, he has authored globally recognized publications and earned prestigious awards including the PMI Cleland Award and an APEX Award for Publication Excellence. His work is showcased on [www.lessonslearned.info](http://www.lessonslearned.info), a hub for knowledge sharing and performance evaluation resources.
Backed by Pfizer, Willis earned a doctorate in Evaluation under the mentorship of renowned scholar Dr. Michael Scriven. This rigorous academic foundation underpins his success in supporting FDA, OSHA and EPA regulatory compliance and designing impactful training programs for process improvement.
DR. ELIZABETH B. VADAS, PhD, FAAPS, FCSPS.
InSciTech Inc.
Dr. Vadas has 40 years of experience in the Pharmaceutical Industry. She spent 22 years at the Merck Frosst Centre for Therapeutic Research in Montreal, the last 11 years of it as the head of the department of Pharmaceutical Research and Development. Her most significant technical accomplishments at Merck Frosst were the product development efforts of the department under her leadership, which lead to worldwide regulatory approval of several products, among them SINGULAIR®, Merck’s oral asthma therapy for adult and pediatric patients, and VIOXX® and ARCOXIA™, two Cox-2 inhibitors for the treatment of pain, osteoarthritis, and rheumatoid arthritis. In addition, Dr. Vadas also was responsible for Merck’s ophthalmic development group in Chibret, France during the development of Trusopt®, and Cosopt® for the treatment of glaucoma.
In mid-2002 Dr. Vadas decided to take early retirement to establish her own consulting company InSciTech Inc., providing integrated solutions for scientific and technical problems faced by life science companies in the compound selection, characterization, and product development areas.
Dr. Vadas has published and lectured widely. She has been elected a Fellow of AAPS and CSPS and has been awarded a Lifetime Achievement Award by CSPS for her scientific accomplishments.
Dr. Ofer Yifrach-Stav, BSc, MsC
Principal Consultant
YS Consulting
Ofer Yifrach-Stav has 18+ years of experience in the pharmaceutical, biotechnology and medical device industry, focusing on compliance, quality assurance and validation aspects. He has a BSc in Biotechnology Engineering, an MSc in Environmental Engineering, and a PhD in Computer Science. Ofer is a certified ISO Lead Auditor in ISO 9001:2015, ISO 13485:2016, and ISO 27001:2022.
Additional Speakers To Be Announced Soon!
Conference Chair
Alan Golden, MS
Principal
Design Quality Consultants, LLC
Alan has over 30 years of experience in the medical device industry, both in basic research and in quality assurance. Alan spent 31 years at Abbott Laboratories. For the first 16 years as part of diagnostics R&D, he developed recombinant proteins used in diagnostics tests, received three US patents and published numerous papers and abstracts. Alan then transitioned to a quality assurance role where in both the Abbott Diagnostics and Abbott Molecular divisions, he was responsible for quality assurance for new product development, on-market product support and operations.
Alan’s quality assurance experience extends from design control, change control, risk management, CAPA, process and test method validation and statistics. He has been lecturing on these topics worldwide for over 25 years.
Alan retired from Abbott in 2018 and now runs Design Quality Consultants, providing training, workshops and seminars in many areas of quality assurance.
Alan received his BS degree in Microbiology from the University of Michigan and his MS degree in Molecular Biology and Immunochemistry from the University of Illinois.
SPONSORSHIP & EXHIBITION OPPORTUNITIES
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