Dalia Haddad is the Senior International Advisor in the Health Product Inspection and Licensing Division. Prior to this position, Dalia held several positions within the Division ranging from Senior Regulatory Compliance and Enforcement advisor to Acting manager for GMP Transformation. Dalia has a honors degree from the University of Ottawa specializing in Biopharmaceutical sciences. Dalia has been working with Health Canada since 2008 and more specifically with the Health Product Compliance Directorate for the past 7 years.
Jessica Paterson is Corporate Compliance and Enforcement Advisor in the Health Product Inspection and Licensing Division. She has been with the GMP team for 5 years. Prior to working at Health Canada, she worked in the private sector at a radiopharmaceutical company for 11 years as both a Production Technician as well as a Research and Development Technician. Jessica has an honors degree from Queen’s University with a subject of specialization in Life Sciences.
Camille Bienvenue has been with the Drug Establishment Unit for over 4 years. She is a Regulatory Affairs Advisor in the licensing management section of the Drug Establishment Licensing Unit (DELU). She also acted for 8 months as the supervisor of the licensing management team. She graduated with honours from the University of Ottawa with a Bachelor degree in Biopharmaceutical Sciences.
Neola Henry is a Senior Corporate Compliance and Enforcement Advisor in the Health Product Inspection and Licensing Division. Prior to this, Neola was a Compliance and Enforcement Inspector for Health Canada’s drug GMP and Medical Devices programs. She also worked in the private industry in the area of Regulatory Affairs for seven years and holds a Masters of Science from the University of Manitoba.
Shailla Nargundkar is the Supervisor, Drug GMP HQ Team 3 in the Health Product Inspection and Licensing Division. Prior to this, Shailla worked in various roles within Health Canada including the Natural and Non-Prescription Health Products Directorate and the Pharmaceutical Drug Directorate. Shailla also worked in the non-profit sector before joining Health Canada in 2005. Shailla holds a bachelor’s degree in Biology from Carleton University.
DAVID L. CHESNEY, MSJ, is the Principal and General Manager for DL Chesney Consulting, LLC, providing GMP and GCP compliance consulting and training services to clients world wide. Previously he served for over 20 years as Vice President, Strategic Compliance Services for PAREXEL Consulting. Prior to joining PAREXEL Consulting, he served 23 years with the FDA as an Investigator, Supervisory Investigator, Director of Investigations and ultimately as District Director in San Francisco, managing all FDA operations in Northern California, Nevada and Hawaii.
Mr. Chesney has an MS in Jurisprudence, concentrating in Pharmaceutical and Medical Device Law, from Seton Hall University School of Law, a Bachelor’s degree in Biology from California State University, Northridge, plus three years of graduate study in Biology at CSU Northridge and CSU San Diego. Mr. Chesney is a member of PDA, where he serves on the faculty of the Training and Research Institute. He serves as a Guest Lecturer for the Maine Regulatory and Ethics Training Center, University of Maine School of Law, and is also active in the Food and Drug Law Institute and RAPS.
Nadine Ritter has been a protein scientist for over 30 yrs, with 10 yrs basic academic research in bone biology followed by 20+ yrs in biopharma CMC analytics. She received her BS in biology/chemistry from the University of Houston – Clear Lake, and her MA and PhD in cell and molecular biology from Rice University, followed by an NIH postdoc at the University of Texas – Houston. Afterwards, she joined the biotech industry as a senior scientist at Abbott Laboratories for the development, validation, tech transfer and troubleshooting of protein analytical methods for a wide variety of proteins and peptides. Later, she became Director of Analytical Services at one of the first biopharma analytical CROs, BioReliance, where she managed contract R&D, GLP and cGMP laboratory operations in standard and state-of-the-art physiochemical and functional methods of analysis. Her next step was as a senior CMC analytical consultant at Biologics Consulting Group, contributing to numerous product submissions and laboratory inspections around the world for 10 yrs. In 2014, she launched Global Biotech Experts, a technical, regulatory and quality consultancy for biopharma products. For the last two decades, Nadine has been a writer, speaker and trainer in CMC analytical science and laboratory compliance for biotech products. She is President of the Board of Directors of CASSS, and is a founding member of the CASSS CMC Strategy Forums. She is a past member of the BioAB of PDA, and contributed to the PDA Method Qualification TR. She has been on the editorial board of BioProcess International from its inception, and has numerous publications on biotechnology analytical methods and laboratory quality practices. Nadine is frequently invited around the world to speak, consult and train for biotechnology product development, post-market changes, and compliance requirements for testing laboratories.
Steven brings over 30 years of experience in clinical and CMC statistics. As a consultant he has worked with both medical device and pharmaceutical companies. His bring expertise is in determining the most efficient clinical trials design to minimize costs and sample size.
Mr. Walfish has held positions at United States Pharmacopeia (USP), Becton Dickinson, GE Healthcare and other FDA regulated companies.
Mr. Walfish has authored or co-authored over 25 peer reviewed articles. He was an editorial review board member for BioPharm.
Mr. Walfish holds a Bachelor of Arts in Statistics from the University of Buffalo, Master of Science in Statistics from Rutgers University and an Executive MBA from Boston University.
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 10 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.
Over 24 years of experience in Pharmaceutical/Medical Device and Consumer Healthcare environment with extensive experience in end to end processes such as Computerized Systems Validation, Data Integrity, Cleaning Validation QMS, SDLC, Agile and Waterfall Methodologies, Validation and Qualification (within, IT, Laboratory, Manufacturing for Standalone through Enterprise Systems), IT Policies and SOP generation, review, revision and approval, IT Infrastructure Review and Qualification/Validation and Audit/Documentation, overall Audit/Assessment Execution with GAP Generation and Remediation, Customer and Vendor Audit and Compliance Quality Assurance Compliance and Laboratory Analyses. Possesses wide knowledge of US cGMP (21 CFR Part 210-211 and 820), GxP Guidelines, 21 CFR Part 11, EU Annex 11, ISO 9001 and 13 ALCOA+ Data Integrity Principles, GAMP 5 and main FDA Guidance(s) for Industry. Autonomously and effectively perform the execution of a GxP and/or ALCOA+ Data Integrity Assessment by directing critical business relevant conversations with client leadership and internal stakeholders. Review and critique of client-produced validation documentation focusing on GxP requirements. Proven track record in enhancing staff performance, validation documentation technical writing and leading high-performing teams.
Developed and maintained accurate departmental resource models to facilitate resource allocation and availability, and to ensure feasibility of projects, from scoping stage through to completion. Maintain close communication with stakeholders and team members to keep apprised of computerized system needs, impacts on computer validation, project validation status, and other relevant issues. Solid competencies in leadership, conflict resolution, oral and written communications, acumen and persuasion as well as organizational savvy.
Mr. Walia has also been a leading Industry Speaker in the Pharmaceutical and Medical Devices Arenas with focus on Cleaning Validation, OOS/OOT (Investigations, Root Cause Analysis and CAPA’s), QMS, Gap Assessments, Remote Inspections, Consent Decree, Remediation, CSV/CSA, Data Integrity, Digital Governance, Cybersecurity, Compounding Pharmacies, etc. Mr. Walia also is a part of the IVT Executive Advisory Board, Chairperson for IVT’s Compounding Pharmacy and ISPE member.
Mr. Walia has over 100 FDA Audits/Inspections under his belt as well as 3 Major Consent Decree Projects focusing on Computer Systems Validation and Data Integrity and is also former Director of R&D, Quality and IT CSV.
Mr. Walia is currently as Senior Global Director of Business Development and Principle SME of Computer Systems Validation and Data Integrity at PQE Group (Pharmaceutical Quality Europe).
Matt has 29 years of experience in GMP Manufacturing, Quality, and Learning & Development roles of increasing responsibility at both global commercial companies and startups. He is an expert in SOP Writing, Human Error Prevention, cGMP, Quality Systems, and Learning & Development, and has designed and delivered highly regarded, effective, and interactive training extensively in these areas for many years. He is a member of ATD, and was the former lead instructor for the Massachusetts Biotechnology Council.
Stephen Tyrpak is a senior level healthcare professional with over 12 years’ experience working with pharmaceuticals, medical devices and combination products. His areas of expertise are regulatory strategy, non-clinical and clinical testing, compliance and quality management systems. He is an Executive consultant at the PQE Group where he also leads the operations for Medical Devices in US & Canada.
Mr. Tyrpak has spent years helping companies develop strategies not only to achieve market notification in and out of the US and Canada but also post market compliance, US reimbursement and US Breakthrough Device Designation. Besides his work with medium to large size companies, a large portion of his career has been spent working with Startup Companies. In the last 3 years, he has helped 9 US based startups raise over 60 million dollars in private seed funding and state and federal grants.
Mr. Tyrpak is recognized as a commercialization expert and is regularly asked to speak and be a panel expert in the fields of; US Regulatory Strategy for PMA or De Novo Devices, US Go to Market Strategy, Post Market Compliance, US Reimbursement Strategy and Startup Business Strategy and Fundraising. Mr. Tyrpak is also a peer reviewed author and sits on the Board of Directors for the Mental Health Advocates of WNY as well as the University at Buffalo’s Center of Excellence in Bioinformatics and Life Sciences and Center for Assistive Technology Industry Advisory Board. He was named one of Western New York’s 30 under 30 in 2021 and was awarded the Courage to Come Back Award in 2022 for is work in the mental health community.
Mathieu Fournier presently serves as Director, R&D and Scientific Affairs 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 15 years of experience in applied research & development within the pharmaceutical industry. Over the course of his career, he has managed new method development projects for oral dosage forms, ophthalmic solutions and injectable products. These projects have enabled him to develop a solid expertise in method development and validation, as well as in forced degradation and dissolution studies, reverse engineering and process automation. He is also experienced in providing answers to health authorities as a subject matter expert.
Mathieu also worked on commercialized drug products for analytical troubleshooting, source changes, site changes and monograph updates. His background in mass spectrometry (GC/MS and LC/MS) brought him to develop an expertise to conduct complete extractables & leachables studies for various packaging systems. He has also acquired an in-depth knowledge to perform risk assessments for genotoxic impurities (like nitrosamines) and for the identification of unknown peaks. More recently, he extended his knowledge to ICP-MS by leading projects for the method development of elemental impurities determination as per ICH/USP new guidelines.
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).
Masha has more than twelve years of experience in the pharmaceutical and biotechnology industries, in Canada, the United States and in Europe. Having started her career as a validation specialist in the pharmaceuticals injectables industry, she has pursued her professional path in the field of consulting. This gave her the opportunity to cover a wide range of mandates in engineering, validation and project management in the life sciences industries.
Masha opened an engineering and consulting firm in 2018, which has since grown to successfully support smaller and larger projects in the Montreal area.
Masha holds a Bachelor degree in science from McGill University, a Bachelor in chemical engineering from Ecole Polytechnique de Montreal and an MBA from McGill University and is a member in good standing of the Ordre des Ingenieurs du Quebec.
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, Quebec Canada. 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 KENX event!
His latest contribution “User Requirements & Implementation of a Risk-Based, Compliant Stability Management System” in Methods for Stability Testing of Pharmaceuticals (edited by Edited by Bajaj, Sanjay, Singh, Saranjit, 2018). He is also an international speaker for ISPE, PDA, IVT, IPA, KENX, EXPOFARMA among many other global associations.
With over 20 years of experience in the Pharma industry, Kia has accomplished to build himself a unique profile. This was achieved by tying his electronics engineering and software development background to GMP Computer System Validation and Analytical Instrument Qualification and Management.
With the technical knowledge of main CDS solutions in the market, business processes, and successful records of CDS validation, he is actively working as a reliable resource for many companies looking for selection, implementation, and validation of Chromatography Data Systems.
If you’re from the Montreal area and you’ve been working in the Pharma Industry you most probably know Adam, he is the founder of Abrévia inc, he worked in validation, QA, and Production, in various positions from technician, to supervisor to manage and Site Director for global companies such as Pfizer, Novartis, gsk, and for local Canadian Companies such as Odan Laboratories.
Dr. Vincent has over thirty-three (33) years of experience in the health care industry specializing in the Biotechnology and pharmaceutical industries. He has over (26) twenty-six years dedicated to the field of validation (commissioning and qualification [C&Q]). Dr. Vincent has B.Sc. degrees in industrial microbiology and a Master of Public Health and Ph.D. He has hands-on experience in many areas of Regulatory Affairs, Quality Assurance, Commissioning/Qualification, and Engineering including regulatory submission preparation, Cleanroom Design Review, Microbiology Laboratory setup and qualification, Cleaning/Process Validation, Project Management, Utility and Process FAT/SAT Commission Plans, and Equipment Qualification implementation. Dr, Vincent is especially strong in the areas of Upstream and Downstream Process Development and Validation and developing and implementing Cleaning Validation, Aseptic Process, and Environmental Monitoring Programs. Most of his career has been in the Biological vaccine industries, but he has also supported the Medical Device, Biopharmaceutical, and Biological industries.
Vincent has spent the last twenty-seven (27) years providing validation and quality consulting services to various national and international companies, including project management and project execution services. Dr. Vincent is an ASTM committee member for Manufacture of Pharmaceutical and Biopharmaceutical Products – E55 (20-07), Microbial/Sterility Assurance for Pharmaceutical and Biopharmaceutical Products – E55.06 (20-01), WK74412 – New Standard Critical Airflow Visualization, and WK69826 – Standard Template for Environmental Monitoring Trend Analysis and WK77957 – New Guide for Standard Guide for Cleanroom Gowning.
Dr. Vincent also coauthored the ISPE GUIDE: Cleaning Validation Lifecycle – Applications, Methods & Controls.
He is responsible for managing and supporting many different product launches. He teaches at San Diego State University (SDSU) for their Masters of Regulatory Affairs Degree program in the Field of Validation Technology RA-776.
Natasha Demberg is a Quality and BD Executive in the Life Science and Health Care industries such as Pharmaceutical, Cosmetics, Medical Devices, Natural Health Products, Cannabis, and Biotechnology. She has 30+ years in the development and application of Quality Management Systems throughout the product life cycle (development, scale-up, and commercialization) and Business Development for Pharmaceutical service providers. She is experienced in leading multi-functional groups to address challenging global regulatory compliance issues, develop strategy for Quality and Business Development, and create company culture oriented to Quality and Customer needs. Mrs. Demberg has Quality and Compliance expertise that spans cGMP compliance-Regulatory Bodies inspections, ISO and NIOSH certifications. Mrs. Demberg is an expert in PAI readiness, FDA and HC Mock Inspections, internal audits and suppliers and vendors audits and qualifications. As a BD executive Mrs. Demberg has an expertise of creating the client and business-oriented company culture, efficient customer support and services.
Currently, Mrs. Demberg is the leader of Demberg PharmaSolutions (DPS) consulting company that provides Quality & Compliance, consulting services for firms in the Life Science and Health Care industries for medical devices, pharmaceutical, cosmetic, cannabis, natural health, and investigational products. . DPS helps their clients in the creation of an efficient QMS that supports the business needs, DPS also performs thorough internal investigations, CAPAs and Deviations. In addition to Quality & Compliance, DPS works with all the departments to create a quality and business-oriented company culture and align objectives to the client’s business needs.
Natasha is known for her dynamic leadership style and her ability to think strategically and outside of the box. She brings with her the tremendous mix of technical expertise, regulatory knowledge, and her business sense. Due to her ability to operate on an executive level she brings together business and quality and develops a common language between the two.
Mrs. Demberg’s career has included a wide range of successful leadership positions in Quality Organizations of several companies in the pharmaceutical field. Initially as a chemist at Teva and Abbott Laboratory and later as Senior GMP Compliance Associate at Merck Frosst Canada, responsible for Quality aspect of Clinical manufacturing, Confab Laboratory Director of Quality Operations, Vice President of Quality Operations at Valeant Canada and Vice President of Operations and Pharmaceutical Solutions at Neopharm Labs, and many others. Currently Natasha is the Founder and President of Demberg PharmaSolutions (DPS).
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.
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