Mr. Paul Gustafson
Regulatory Operations and Enforcement Branch
Health Product Compliance Directorate
Health Product Inspection and Licensing Division
Health Canada

Mr. Paul Gustafson is providing representation at the 2020 International Pharmaceutical Academy (IPA) Stability Program Virtual Conference on behalf of Health Canada. He is a Senior Corporate Regulatory Compliance and Enforcement Advisor within the Regulatory Operations and Enforcement Branch of Health Canada. The Health Product Inspection and Licensing Division within this branch supports the assessment of GMP compliance of establishments engaged in various activities relating to veterinary drugs, human drugs, and active pharmaceutical ingredients.

Paul’s background includes 17 years of experience within Health Canada that has been complemented with 10 years of pharmaceutical industry experience. He has gained a wealth of industry related skills through various quality related positions ranging from quality control chemist positions to vice president, quality and compliance.

Farzana Saadat
Acting Supervisor, GMP Inspections Head Quarters National Unit
Health Product Compliance Directorate
Health Canada

Farzana Saadat currently works as an acting Supervisor for the GMP Inspections Head Quarters National Unit within the Health Product Compliance Directorate. She comes with a Bachelor of Science degree in biochemistry and a Masters in public Health. She has taken on varying roles in different capacities ranging from policy analysis, pre-market review and approval, to licensing and compliance and enforcement activities. She started her public service career in Ottawa with the Public Health Agency of Canada as a policy analyst. In 2011, she joined Health Canada as a regulatory project manager for the Therapeutic Products Directorate where she managed the review and approval of drug submissions for human pharmaceutical health products. In 2016, Farzana took on a role as a supervisor for the Office of Controlled Substances within the Controlled Substances and Cannabis Branch where she managed licensing and permit activities related to industrial hemp. In 2019, Farzana joined GMP headquarters. In her spare time, Farzana enjoys spending time with her daughter, kick boxing, baking, and gardening.

Dr. Steven Baertschi,
President, Baertschi Consulting LLC

Dr. Steven Baertschi is President of Baertschi Consulting, a firm specializing in solutions to the most difficult stability, impurity, analytical, solid-state, and formulation issues. Retiring from Lilly in 2015, he brings more than 30 years of experience in the pharmaceutical industry to his consulting firm, with a demonstrated track record of innovation and problem-solving. He obtained his PhD in Organic Chemistry in 1989 from Vanderbilt University, joining Lilly that same year. Dr. Baertschi has organized / Chaired numerous scientific conferences / symposia on stress testing, stability, photostability, and impurities, has published more than 55 refereed scientific articles, almost 30 book chapters, and two editions of a book on pharmaceutical stress testing / drug degradation. Dr. Baertschi is a member of the American Chemical Society (1980), the American Association of Pharmaceutical Scientists (AAPS, 1993), is a Fellow of the AAPS (since 2007), and has been awarded the Albert Nelson Marquis Lifetime Achievement Award by Marquis Who's Who.

Dr. Geoff Carr,
Director, Analytical Development, Ontario Pharma Services Patheon, part of Thermo Fisher Scientific

Geoff Carr was appointed as Manager, Analytical Development at Patheon Inc, Canada in 2000 and is now Director, Analytical Development, Thermofisher Patheon. Prior to that, he held positions of Manager, Analytical Sciences at Celltech-Chiroscience, UK, Head of Analytical Development at Medgenix, Belgium and before that at Wyeth Research, UK. He originally started his career in pharmaceutical analysis at The British Pharmacopoeia Laboratory where he held several posts and was finally appointed Head of the Laboratory. His academic background is a PhD in synthetic organic chemistry awarded by University of London, UK. He has been a Member of various British Pharmacopoeia Committees, a UK representative to Committees of the European Pharmacopoeia and Member of USP Committees and is currently a Member of the 2015-2020 Cycle USP General Chapters – Physical Methods Expert Committee. He is the author of numerous papers, presentations at international conferences and workshops on various topics related to Pharmaceutical Analysis and particularly on the subject of Conducting Stability Studies

Ilona Endisch B.S. in Computer Science ,
Associate Director, Product Innovations - North America, Novatek International

Ilona Endisch, BCompSc., is the Associate Director of Product Innovations at Novatek International. With over 15 years of working in regulated industries, Ilona works with world-wide clients to assist in their URS and process mapping of software including contamination control software and helps to identify new product innovations. Ilona is active in the industry, giving presentations and performing trainings in topics related to software, microbiology, quality management, risk assessment, and other areas. Ilona is currently teaching a class on Trending as part of the Aseptic course given by the PDA-TRI.

Dr. Kristina Flavier,
Sr. Scientist, FreeThink Technologies, Inc.

Kristina Flavier obtained her B.S. in chemistry from the California Institute of Technology and her Ph.D. in organic chemistry from Stanford University. In 2017, she joined FreeThink Technologies, Inc. in Branford, CT. As a Senior Scientist in the Physical Sciences group, she focuses on understanding the factors that influence physical and chemical stability and supports clients in solving complex stability problems. She uses the Accelerated Stability Assessment Program (ASAP) approach and FreeThink’s ASAPprime® software to predict shelf life and recommend optimal packaging conditions for products in the pharmaceutical, food, and consumer health industries.

Christopher (Chris) V. Latoz, B.S. ,
Stability Manager, Hollister Incorporated in Libertyville, IL

Christopher (Chris) V. Latoz is Stability Manager at Hollister Incorporated in Libertyville, IL. Chris has over 27 years’ experience in the medical device industry (Class I and II devices) working in R&D, Technical Services, and more recently, Stability.

While at Hollister, Chris has led several process and capacity improvement projects, including: the implementation of a LIMS (Laboratory Information Management System) for stability sample and data management; the construction of new walk-in stability storage chambers; and the implementation of a temperature and humidity monitoring system for stability chambers. Chris received a B.S. in Mathematics and Chemistry from Illinois State University and a Master’s in Chemistry (Analytical) from Illinois Institute of Technology.

Dr. Nanda Subbarao ,
Group Leader & Senior Consultant, Biologics Consulting

Dr. Subbarao is currently the Group Leader for Analytics CMC Group and Senior Consultant with the Biologics Consulting Group specializing in Analytical, Stability, CMC and GLP/GMP Quality Systems. She has assisted pharma and biotech organizations in evaluation of analytical methods and method validation for a wide range of products from pre-clinical phase to commercial phases. Her consulting areas include GMP systems design and implementation focusing on laboratory and stability systems, data integrity and equipment. Some specific technical areas include small molecule pharmaceuticals, well characterized proteins including biosimilars and vaccines. Her projects include Data Integrity audits, FDA regulatory submission preparation and review, audit of laboratory GMP/GLP systems and advice on upgrade of GMP/GLP systems, advising clients for PAI readiness, client training course development and explanation of FDA regulations. She currently serves as an Editorial Advisor for BioProcess International.

Dr. Peter Tattersall ,
Senior Principal Scientist, Bristol-Myers Squibb Company

Peter Tattersall, Ph.D. is a Senior Principal Scientist in Chemical and Synthetic Development within Pharmaceutical Development at Bristol-Myers Squibb Company in New Brunswick. He received his BSc. and Ph.D. from the University of Manchester, UK. He previously worked in Analytical Development at AstraZeneca, Wilmington. He joined Bristol-Myers Squibb in 2003 where has worked on both drug product and drug substance. He is currently a project leader and supervises a group of analytical chemists working on method development, qualification and transfer in support of drug substance process development.

Emily S. D. Trubee, MS ,
Stability Manager, R&D, Adare Pharmaceuticals, Inc.

Emily Trubee is a pharmaceutical professional with 15 years of experience in Quality Control, and Stability Testing and Management, with a focus on regulations-compliant stability programs for sterile injectables, solid oral dosage forms, and biological products. In her current role as Stability Manager at Adare Pharmaceuticals, she is responsible for managing the stability lifecycle of all products from pre-clinical through commercialization. Emily earned her Bachelor of Science degree in Chemistry from Wilmington College in Wilmington, OH and her Master of Science degree in Quality Assurance and Regulatory Affairs from Temple University School of Pharmacy.

Kia Kahhali
Founder and CEO
APS Compliance Consultants Inc.

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.

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

Dr. Pauline L McGregor , CChem MRSC
PMcG Consulting, Canada

Dr. McGregor has fulfilled a variety of roles in over thirty years in the pharmaceutical industry. She is an expert in quality systems and procedures, GMP regulations and analytical chemistry. Her technical expertise in these roles has enabled her to participate in troubleshooting and improving analytical procedures, manufacturing processes and formulation development, to evaluate changes and improvements and assess the impact of these on the product/patient. Dr. McGregor is a renowned trainer in her areas of expertise, has spoken at many international conferences, participated in writing USP stimuli articles, and coauthored and peer reviewed several publications. Dr. McGregor has utilized her skill set globally in the UK, Canada, US, Jordan, Brazil, and China and is a member of The Royal Society of Chemistry, UK. She is currently a volunteer USP expert advisor.