Distinguished Speakers & Panelists:

Teresa Forlini, B.Eng. Chemical Engineering
Manager, GMP Inspection – East/West,
Regulatory Operations and Enforcement Branch,
Health Canada/Government of Canada
Health Canada

Teresa Forlini, (B.Eng. Chemical Engineering) is the Manager of GMP Inspections for the East/West region. She oversees the domestic and foreign on-site inspections, as well as paper assessments and risk files. Prior to this, she was the supervisor in the Regulatory Operations and Regions Branch at Health Canada, and has worked as a GMP inspector in the province of Québec. She has been heavily involved in the GMP transformation Initiative in the past 4 years. Prior to joining the public service 9 years ago, she worked in the Pharmaceutical Industry for over 15 years, having held various management positions including continuous improvement, quality assurance and validation.


Magda Joseph, B. Eng.
Regional Supervisor, GMP Inspection - East
Regulatory Operations and Enforcement Branch
Health Canada/Government of Canada
Health Canada

Magda Joseph (B. Eng. Chemical Engineering) is the Regional Supervisor of the GMP Inspection-East unit in the Regulatory Operations and Regions Branch at Health Canada.

She is responsible for overseeing the domestic and foreign GMP inspections conducted by the regional inspectors for FDF and API pharmaceutical sites, to ensure that the drug products and related activities comply with the current regulations and guidelines. Prior to joining the GMP Inspection team 9 years ago, Magda worked for 10 years in the pharmaceutical and pre-clinical industry, where she held positions in compliance, quality assurance and computer system validation departments.


Tonino Antonetti
Tonino Antonetti, M.Sc.
Executive Director, Regulatory Affairs & Quality Management,
Roche Diagnostics
Roche Diagnostics

Mr. Antonetti holds a Masters of Science degree (M.Sc.) in Biophysics with a Specialization in Neuropharmacology. With more than 15 years of experience in the Regulatory Agency (Health Canada), Pharmaceutical and Medical Device industry, he has acquired extensive experience and understanding of the GMPs including sterile manufacturing, GCP and Medical Device Regulations. While at Health Canada, he worked in the Drug Investigation Unit, the Medical Device Unit and the GMP Inspection Unit where he was a member of the GMP Committee and contributed to the development and enhancement of Regulations, Policies and Guidelines. He currently holds the position of Director, Regulatory Affairs & Quality Management at Roche Diagnostics where he is responsible for all aspects of Licensing, Compliance and Quality. He is actively involved with MEDEC representing the Medical Device industry during meetings held with Health Canada and other stakeholders.


David Chesney
David L. Chesney, MSJ
Principal and General Manager 
DL Chesney Consulting, LLC
Former FDA
Former FDA

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.


Mathieu Fournier
Mathieu Fournier, M.Sc.
Director, R&D and Scientific Affairs
Neopharm Labs
Neopharm Labs

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).


Alan Golden
Alan Golden, BS, MS
Principal
Design Quality Consultants, LLC
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 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.



Michael Hodgkinson
Michael Hodgkinson, B.S.
Owner and Principal Consultant
Orvera Scientific Ltd.
Orvera Scientific

Michael Hodgkinson is currently Owner and Principal Consultant at Orvera Scientific Ltd. Michael has 20 years of experience in the sterile pharmaceutical, therapeutic biologicals and vaccines manufacturing industry. He holds a Bachelor’s degree in Microbiology from the University of Guelph in Canada. He has held senior leadership roles in Canada and the United States in QC Microbiology, Manufacturing, Validation, Manufacturing Sciences, Quality Assurance and Sterility Assurance. This includes experience in design, validation, testing, risk management, contamination control and sterility assurance controls for aseptic manufacturing processes.


Adam Hazourli
Adam Hazourli, BSc
Co-founder
Abrevia Incorporated
Abrevia

Adam Hazourli is the president and Co-founder of Abrévia International Incorporated for GMP and Pharmacovigilance Compliance Services, seminars and workshops. Abrévia is a trusted partner for the industry across North America, APAC and Europe. Since 2016, Abrévia Inc has been onboarding new associates to it's team, talented professionals willing to bring their careers to the next level, by making the difference for our partners within and across the Life Science Industries.



Kim Huynh-Ba
Kim Huynh-Ba
Executive Director
Pharmalytik Consulting & Training

Editor of the “Handbook of Stability Testing for Pharmaceutical Products: Regulations, Methodologies and Best Practices”

Kim Huynh-Ba is the Executive Director and CEO of Pharmalytik Consulting and Training Services. She provides consulting and training services to pharmaceutical companies, including those operating under FDA’s Consent Decree. She has over 28 years of experience supporting the development of Quality System Management (QSM), risk management, project management, strategic drug development and stability sciences.

She is an Adjunct Professor at Temple University-School of Pharmacy and Illinois Institute of Technology (IIT), teaching pharmaceutical analysis, quality audit, ICH Quality guidelines and GMPs. Kim is also an instructor on cGMP compliance and quality topics for several global organizations such as ACS, AAPS, Pittsburgh Conference, and US Pharmacopeia.

Currently, she is a member of the USP Council of Expert, chairing the Small Molecules 4 Expert Committee. Kim is also a member of USP Impurities of Drug Products Expert Panel and Supplier Qualification Expert Panels. Kim is a member-at-large of the Governing Board of Eastern Analytical Symposium (EAS) and was their 2013 President. Kim is part of the Steering committees of AAPS Stability, Pharmaceutical Impurities, and CMC Focus Groups. Kim is also an Alternate Councilor of ACS-Delaware section.


Kia Kahhali
Founder and CEO
APS Compliance Consultants Inc.
Teva Canada

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.


Vamsi Kosaraju, M.Sc.
Director, Quality Assurance, Teva Canada Limited
Teva Canada

Mr. Vamsi Kosaraju is a Quality Assurance and Compliance professional, holds a Master’s of Science degree (M.Sc.) with a Specialization in Microbiology. From 2010 to till date, Vamsi Kosaraju’s career has included a wide range of successful progressive positions at Teva Canada Limited.

In his current role, Vamsi Kosaraju leads Quality Assurance activities of all Solids and Suspensions facilities of Teva Canada Limited. This oversight includes but not limited to the establishment and execution of procedures; Quality on the Floor activities including audit and final product release; handling of laboratory, deviation, complaint investigations, CAPA creating and implementation; streamline KPIs, trending and benchmark consistent measures to encourage and to monitor performance and ensure that facilities and equipment, utility systems, manufacturing and packaging operations are maintained, sustained in accordance with established procedures. In this capacity, he led numerous domestic and international regulatory inspections conducted by Health Canada, USFDA, South Korea, Russia and customer audits where the outcome was successful.

With more than 16 years of hands-on and executive experience in pharmaceutical and medical device industry, he has acquired extensive experience, empowered multi-functional employees and high-level understanding of the GMPs. Mr. Vamsi Kosaraju is active in the Canadian Generic Pharmaceutical Association (CGPA) Quality & Compliance Scientific Committee and provides strategic compliance view in developing solutions that supports a more sustainable healthcare system in Canada.


François Lavallée, M.Sc.
President, Aliter Concept

Passionate about training since 1996 and consultant in this field since 2005, Francois Lavallee acquired a solid experience in training management as a trainer and training manager at Abbott Labs and Wyeth Canada from 1994 to 2005. His science background in molecular biology could not have prepared him for this career but his love of knowledge sharing decided otherwise.

Specializing in regulatory awareness, Aliter Concept delivers dynamic and surprising performances to stimulate participants' engagement. Although pharmaceutical companies are our main revenue-generating clients Aliter Concept is not limited to regulatory training. An important part of our activities focus on Communities of Practice or CoP. Aliter Concept is responsible for CoPs in quality management ( Collectif de Réflexion en Amélioration de la Qualité ), organizational development (Collectif de Réflexion sur l’Organisation Intelligente ) , managers development ( Collectif de Réflexion en Innovation Manageriale and Collectif de Réflexion en Agilité Manageuriale ) and training ( Collectif pour l’Apprentissage, la Formation et l’Éducation ). Meetings and events facilitation, meeting management, time and change management, communication skills or other customized training session are also part of Aliter Concept activities.

Mr. Lavallee has been a guest speakers at several symposium and meetings in Canada and in the U.S.A.. His speeches have always been dynamic, surprising and very well received, conforming to Aliter Concept mission.

Francois Lavallee’s passion for training and human capital development is reflected in his 650+ blog post and 17 books and ebooks.


Ovidiu Minailiuc, Ph.D. ing.
GMP & Compliance Director
Macco Organiques
Macco

Ovidiu Minailiuc has over 30 years experience in pharmaceutical, bio-pharmaceutical and chemical industry in Europe and Canada, where he has developed expertise in GMP System implementation, qualification, cleaning and process validation of “batch to batch” and continuous processes, 21 CFR Part 11 and Computer Systems Validation, stability, technology transfer, drug development, protein-drug interactions and proteins NMR 3D structural studies, formulation, scale-up, equipment design and process improvement for drug and API manufacturing processes.

Experienced in API, biopharmaceutical and drug manufacturing regulated industries for DEL approval, certifications and regular Health Canada and EMA inspections and pre-approval and post-approval FDA inspections.

He holds an Engineer diploma (M.eng) with a Major in Pharmaceutical Technology, as well as a PhD in Organic Chemistry in Drugs Design and Development.


Carlos L Pereira
Regional Manager of Canada
VTI Life Sciences
VTI Life Sciences

Biograhy will be available soon.


Nadine M. Ritter, Ph.D.
President and Senior Analytical Advisor
Global Biotech Experts, LLC
Global Biotech Experts

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.


David W. Vincent, PhD
CEO
VTI Life Sciences
VTI Life Sciences

David Vincent has over 28 years experience in the health care industry with 24 years in field of validation. He has BS degree in Industrial Microbiology and Mechanical Engineering Technology degree; he has consulted for many companies national and international. Mr. Vincent has expertise in many areas of Quality Assurance, Regulatory Affairs and Validation, including BLA submission preparation, facility and equipment design review, computer system validation, process development and validation, project management, utility and process equipment qualification. He has been involved in the various aspects of bringing many new drug manufacturing facilities on-line, from design concept and engineering, through construction, commissioning, to the qualification/validation, and licensing phases. He has presented many training seminars and written many articles regarding validation topics. He teaches “Validation Program for Pharmaceutical, Biotechnology and Medical Device Industries “RA 776” at San Diego State University (SDSU) for their Regulatory Affairs Master Degree program. Currently, he is the Chief Executive Office (CEO) of Validation Technologies, Inc. a Global Validation and Technical Services Company.


Steven Walfish
President
Statistical Outsourcing Services

Mr. Walfish is Principal Science & Standards Liaison at United States Pharmacopeia (USP) responsible for the Statistics Expert Committee.  Prior to this role Mr. Walfish was Principal Statistician at Becton Dickinson in Franklin Lakes, NJ responsible for supporting continuous improvement efforts and process development for worldwide operations. Mr. Walfish has held roles at GE Healthcare, Human Genome Sciences and Chiron. Steven was President of Statistical Outsourcing Services, a consulting company that provides statistical analysis and training to the FDA regulated industries.

Mr. Walfish brings over 30 years of industrial expertise in the development and application of statistical methods for solving complex business issues.   Steven has experience applying statistical methods to analytical method verification and validation and stability analysis.

Mr. Walfish holds a Bachelors of Arts in Statistics from the University of Buffalo, Masters of Science in Statistics from Rutgers University and an Executive MBA from Boston University.


Conference Chair:
Natasha Demberg, BSc, MSc
Quality & Compliance
Demberg Pharma Solutions
Demberg Pharma Solutions

Natasha Demberg is a Pharmaceutical and Biotechnology Quality and BD Executive with 25+ 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 audit expertise that spans cGMP compliance, mock-FDA and HC inspections, PAI readiness, and suppliers and vendors audits and qualification. As a BD executive Mrs. Demberg has an expertise of creating the client oriented company culture, efficient customer support and service, and Business Development and sales.

Currently, Mrs. Demberg is providing Quality & Compliance, consulting services for Pharmaceutical and Biotechnology firms. In addition to Quality & Compliance, Mrs. Demberg provides Business Development support to the service companies in Life Science industry.

She is known for her dynamic leadership style and her ability to think strategically. She brings with her the tremendous mix of both technical expertise and regulatory knowledge.

Natasha’s career has included a wide range of successful leadership positions in Quality Organisations of several large companies in the pharmaceutical field. Initially as a chemist at Plantex Teva and Abbott Laboratory and later as Senior GMP Compliance Associate at Merck Frosst Canada, responsible for Quality aspect of Clinical manufacturing, Head of Quality at Valeant Canada and Confab Laboratory responsible of entire Quality Operations, and Vice President Pharmaceutical Solution at Neopharm Labs.

Mrs. Demberg holds a BSc in Chemical Engineering and a MSc in Chemistry of Polymers and is a member of the Quebec Chapter of the Society of Chemists, L’Ordre des chimistes du Québec.


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