AAPS leading industry faculty utilizes years of global expertise to bring training sessions to life with engaging instructional methods and real world examples.
Instructor – AAPS
Alicia Ramdass is an experienced corporate trainer and program instructor at AAPS for quality assurance, pharmacovigilance, and clinical research. Her main area of focus are GMP compliance, good documentation practices and handling of complaints and recalls.
Prior to joining AAPS, Alicia gained several years of experience in the pharmaceutical industry. As the Responsible Complaints Person at Eli Lilly Canada, she facilitated investigations into quality issues, and has worked and designed various GMP related quality systems, such as complaints, change control, deviation investigations, and SOP systems. Alicia has participated in several successful regulatory audits in both the Clinical and Quality fields, and brought a passion to training her cross-functional partners on the importance of quality compliance. She now brings the same passion to her students and corporate clients at AAPS.
Alka Mohan is a Regulatory Affairs professional with an extensive knowledge of dietary supplements and natural health products, food, personal care products and consumer goods, medical devices and pharmaceuticals. With a wide variety of work experience, Alka has navigated the regulatory framework in the Canadian, US and international markets. Alka has analytical and communication skills that encompass identifying and resolving complex problems with a highly detailed focus on regulatory requirements. Alka has established a thorough understanding of the manufacturing and operational processes impacting product life cycle and management from a regulatory compliance perspective.
Manager; Scientific and Regulatory Affairs
Alok Kumar was educated in India and received his medical training holding a bachelor’s degree in medicine and surgery (M.B.B.S) and completed master’s in public administration (M.P.A) in United States.
In 2016, Alok completed his Post graduate diploma in Clinical Research, Drug safety and Pharmacovigilance from AAPS, Toronto Canada and currently an AAPS alumni.
He started his journey in Canada as Medical assistant and screener and in span of 7 years he held various capacities in the organization and currently being manager of Scientific and Regulatory Affairs department leading a team of 4 scientific and regulatory associates. He is responsible for overseeing medical writing, regulatory submissions to Health Canada, pharmacovigilance in North America (USA and Canada), obtaining licenses/permits for controlled drugs and Class A precursors for research trials and archival process. In the span of 7 years, he played a role in many successful regulatory inspections at his site and at client’s site. He has established contacts in Health Canada and Ethics board representing as Chief Scientific Officer.
Alok is an affiliated member and certified clinical research professional from Society of Clinical Research Associates (SOCRA). In addition, he is an affiliated member and certified medical lab assistant (MLA) from Canadian Society for Medical Laboratory Science (CSMLS).
Alok has 10+ years of teaching experience and held vocational instructor license (New York State Board of Education) teaching in 2 career colleges in Manhattan, NY USA. He has taught various courses like Medical Assisting, Medical office administration, EKG and Phlebotomy, Medical billing and coding, pharmacy technician etc. He was also involved in curriculum preparation and helped in getting approval for programs in career/private training college. In addition, he was also a certified Instructor (affiliated with American heart Association and Canadian Red Cross) providing initial and refresher trainings for Basic Cardiac Life Support (BCLS), Advanced Cardiac Life Support (ACLS) in NY USA and Standard First Aid in Toronto, Canada.
He brings with him a thorough understanding of regulations, guidelines and regulatory compliance strategies related to pharmaceutical industries. His teaching is always student centered including both traditional and modern approaches. He has excellent communication, good observation and interpersonal skills.
Formulation/Process Consultant – Keller Consulting
Andy Tallevi is a Formulation/Process Consultant for Keller Consulting in Mississauga, Ont., Canada. He has 28 years of industrial experience, primarily in the Pharmaceutical industry. He currently consults clients in the Pharma and chemical industries assisting them with formulation and process issues and is an instructor at AAPS.
Most recently Andy spent 1 year with Health Canada in the Bureau of Pharmaceutical Sciences reviewing and evaluating generic submissions and making recommendations for approval or refusal of Notice of Compliance for the Bureau. He has gained significant insights to the regulatory requirements and expectations of the drug substance and drug product sections of a submission filing to Health Canada. In addition, he has an excellent understanding of the regulatory requirements for pharmaceutical development, the GMP requirements expected for pharmaceutical manufacture and has assisted former employers numerous times in audits by Health Canada and the FDA.
Prior to this, Andy worked as a Senior Pharmaceutics Scientist for GlaxoSmithKline in Canada. During his 18 years with the company he led many projects developing new chemical entities in varying dosage forms. His specialty is solid oral dosage forms. He and his team successfully formulated immediate release tablets as well as many controlled release versions of GSK new chemical entities. He has experience with conventional matrix approaches as well as proprietary technologies such as Procise® and DiffCORE®. He has been responsible for overseeing the manufacture of clinical supplies of NCEs both in Canada and at other GSK sites in Europe and the US.
Andy also has a solid understanding of material properties required of excipients and actives for successful formulation and for robust processes. He is well versed on particle sizing and powder flow. He holds a US patent on a novel approach for the assessment of the flow of pharmaceutical powders.
Prior to leaving GSK he was heavily involved in a company-wide effort to strengthen its processes by Design for Manufacture through the use of PAT and experimental design for which he was the lead user in Mississauga.
Prior to GlaxoSmithKline Andy worked as a scientist for Unilever developing products in the health, beauty and detergent industries. He graduated from the University of Toronto with a B.Sc. major in Chemistry.
Andy lives in Mississauga with his wife and 2 children.
Attia Qamar is a Biomedical Engineer with postgraduate studies in Clinical Research, Bioinformatics and Project Management. Her alma maters include McMaster University, University of Toronto and York University. Attia’s professional journey in Clinical Research started a decade ago and spans industry, academia and health care. She enjoys teaching and brings with her a wide array of real world clinical experiences. She is passionate about patient care and currently works at St. Michael’s Hospital as a Senior Clinical Research Coordinator managing, coordinating and monitoring industry and investigator-initiated multi-site Infectious Diseases Trials.
Atiyyah Ferouz is a cannabis industry professional and the founder of AgCann Consultancy, a cannabis operations consulting agency specializing in process improvements using industry best practices and plant science principles. A plant geneticist by training, Atiyyah completed her Master’s of Science with a focus on plant tissue culture and genetic engineering at Western University through a joint program with Agriculture and Agri-Food Canada. After working in the food industry and gaining experience in quality assurance, regulatory affairs, product development, and recipe development, Atiyyah transitioned into the cannabis industry.
In October 2018, she became the Tissue Culture Lab Manager for a medically focused indoor cannabis producer in southwestern Ontario. In this role she developed tissue culture media recipes and protocols to optimize the nodal propagation method for several cannabis cultivars, and also gained valuable skills and experience in cannabis cultivation and quality assurance. In her next position, as Director of Business Development and Operations Specialist at a 1 million square foot cannabis greenhouse, Atiyyah took on various roles within the cultivation, research and development, quality assurance, sales and marketing, and operations departments.
Atiyyah is passionate about educating individuals entering the cannabis space and is always eager to share her quality assurance and food development experience, working knowledge of HACCP and GMP implementation, and deep understanding of both cannabis and food regulations with students.
Dr. Barkat Ain completed her PhD (Chemistry) in 2014. Her research was a collaborative program between Quaid-i-Azam University, Pakistan; Dalian Institute of Chemical Physics, China and Pennsylvania State University, USA. She has extensive experience of Nanomaterials Synthesis and Characterization. She published various research articles in peer reviewed Scientific Journals and author of one book as well. After completion of PhD, she worked in National Centre of Physics for 2 years as the Assistant Professor.
After relocating to Canada, Barkat started her career in Pharmaceutical sector and got extensive experience for the Method Development and Method Validation for drug Products along with the routine analysis of stability and batch releases. Teaching is her passion. Dr. Barkat is determined to be part of academia along with industry to have a better connection of both sectors in an effective way.
Quality Systems and Compliance in Cannabis Industry
Bilal Al-kadri is a QA professional with 18 years of comprehensive and practical experience in various roles encompassing continuous improvement, operational management and consulting services within the medical laboratories and pharmaceutical fields in North America and the Gulf Region. Bilal has strong knowledge in GMP, GACP, GPP, GAP, GLP, ISO15189, ISO31000, ISO9001, ISO14001 standards, guidelines and regulations. His areas of expertise focus on team development, coaching, consulting and training.
In 2000, Bilal Al-kadri received his B.Sc. in Applied Chemistry and Biology from Ryerson University and in 2001 he earned a postgraduate diploma in Pharmaceutical Quality Assurance from Toronto Institute of Pharmaceutical Technology, Canada.
Dr. Chaitanya Baliga has over twenty years of Quality Assurance, Regulatory and Compliance experience in manufacturing, pharmaceutical, medical devices, toy, food, drug, cosmetics, natural health products and other consumer / service industries in Canada and other parts of the world.
Chaitanya has a strong understanding of regulations that pertains to Health Canada, FDA, ICH, EU MDD, ANVISA, CSA/UL, and ISO 13485/14971. Chaitanya has successfully developed process improvement / operational excellence/ regulatory compliance / licensing and auditing/inspection training programs in pharmaceutical, medical device and other regulated industries. He is technical committee member for medical devices quality management systems standards.
Chaitanya holds a Ph.D. in Materials Science from University of Surrey, UK. In addition, he holds ASQ certifications for Quality Auditor (CQA), Six Sigma Green Belt (CSSGB), and Manager of Quality/Organizational Excellence (CMQ/OE).
Colin brings over 10 years of experience in the Canadian pharmaceutical industry in Quality Control and Research and Development. Colin was a certified trainer at one of Canada largest generic pharmaceutical and guided many chemists on laboratory testing techniques and instrumentation. In addition, he specialized in lab investigations, method verification, method validation, and evaluating pharmaceutical compendia changes against the company in-house methods and specifications to ensure compliance with regulatory requirements for different markets. He was responsible for overseeing and leading laboratory audits and successfully addressed and resolved many GMP and quality issues with in the lab.
Conor Purdon graduated from the University of British Columbia in 2012 with a degree in Medical Anthropology. Following his graduation, Conor worked as a Laboratory Technician within the Environmental Microbiology Laboratory for Public Health Ontario. After three years at the Public Health Lab, Conor returned to school to attend the University of Kent in England where he graduated with a MSc. in Ethnobotany. At Kent, Conor performed graduate research on the use of psychedelic plants as medicine.
After returning home in 2015, Conor gained experience working in the cannabis industry for a number of licensed producers performing responsibilities related to the production, processing, extraction, as well as sales and marketing of medical cannabis. In 2018, Conor was brought on by AAPS to help develop a cannabis retail training and consulting program following the announcement of a private retail model in Ontario. Conor has developed and run a number of workshops and seminars focused on cannabis retail regulations, quality assurance and cannabis management. As a result, Conor has closely followed the development of the Registrar’s Standards for Cannabis Retail Stores, as well as all applicable laws and regulations, including the Cannabis Control Act, 2017 (CCA), the Cannabis Licence Act, 2018 (CLA), and Ontario Regulation 468/18 and has developed a comprehensive knowledge and understanding of the current cannabis retail landscape in Ontario and across the country.
Cory currently oversees the development and implementation of quality management systems in support of safe food manufacturing and cannabis processing. Prior to his involvement in Quality Assurance, Cory served as a Regulatory Affairs Associate providing further compliance to all relevant requirements for site licensing and natural health product applications. His commitment to high-quality health & foods products stems from an academic background in nutritional and nutraceutical sciences at the University of Guelph (B.Sc. Honours), alongside a master’s thesis (M.Sc.) with the department of Biochemistry & Chemistry at the University of Windsor.
Daniel Hochman began his journey in the Cannabis industry as a Grow Technician cultivating medical cannabis within the Health Canada framework for (what is now) Terrascend Canada. Throughout his journey, Daniel played a key role throughout multiple stages of the licensing process including helping obtain a Medical Sales License, GMP certification and the expansion into the Adult Use Market.
Daniel has been a guest speaker at leading cannabis conferences such as the “Grow Up” conference. Currently, when not teaching, Daniel assists clients under his “Habitual Hobbyist” brand where he helps design and build personal medical/recreational grows, and helps cultivators improve their SOPs under the Cannabis Act.
Deborah Gordon, B. Sc., Dip. Pharm. QA/QC, began her career in the Sciences as a Forensic Analyst working on crime scenes and in the lab analyzing evidence to be presented in court. Her attention to detail, which was critical to crime scene investigation, eventually led her to the Quality Assurance field. Her experience as a Forensic Analyst paved the way for her career growth. In pursuit of this exciting new direction, in the year 2000, she completed training at the Toronto Institute of Pharmaceutical Technology (TIPT) where she obtained a Post Graduate Diploma in Pharmaceutical Quality Assurance and Quality Control (Dip. Pharm. QA/QC). In 2008, Deborah completed her training as an Auditor by successfully passing the American Society for Quality Auditor examination, (ASQ, CQA).
Deborah has 16 years of experience in the pharmaceutical industry, including 15 years of auditing experience. Her extensive experience includes warehouse logistics, storage and distribution, wholesaling, importing, packaging/labelling and manufacturing of pharmaceuticals. She has done extensive work in temperature mapping of warehouses, coolers, freezers and stability chambers; this continues to be a niche area for her consulting business. As a leader in pharmaceutical quality assurance, she also enjoys the challenge of auditing, training and motivating employees, building robust quality systems, developing SOPs and setting up new GMP facilities.
Deborah transitioned from the corporate world to pursue her lifelong entrepreneurial dream as the owner of Limitless Pharmaceutical Consulting, where she is both President and Senior Consultant. Deborah also works as a Senior Consultant and Instructor with the Academy of Applied Sciences (AAPS).
Doris earned her B.Sc in Biological Sciences from the University of Alberta and the Post-graduate Certification in Pharmaceutical Regulatory Affairs and Quality Operations from Seneca College. She brings over 10 years of experience in the Natural Health and Food industry with extensive knowledge in produce licence applications, label reviews, site licences as well as Good Manufacturing Practices. During her career in the industry, she has helped launch a wide variety of products such as weight supplements, vegan bars, protein powders, and probiotics. In addition to her knowledge in Regulatory, she was also the Corporate Quality Assurance Manager during her tenure at Clorox Canada, where she implemented and maintained the Quality Management System for Clorox’s product portfolio which included cosmetics, cleaning solutions, natural health products, and food.
She currently works in the Regulatory Department in the Cannabis industry and operates her own NHP and Food consulting business. She enjoys sharing her experience with others and exchange candid discussions on regulations, industry news, and quality assurance.
Food Quality and Safety professional with over 25 years working in the CPG Industry. Knowledgeable of all food quality management programs in Canada and United States, as well as the respective government regulations and standards. Highly skilled working under tight time constraints while investigating food quality issues as part of the company’ Incident Management Team including identifying root cause, corrective and preventive actions on how to prevent a future occurrence. SQF Practitioner and Food Safety Modernization Act Preventative Controls Quality individual (PCQI) certified. Most recently led a North American Food Safety capability improvement initiative across multiple bakery, frozen food and cereal manufacturing facilities in one of 5 regions in North America including providing on-site support for quality innovations and food safety plans, as well as, coach and train manufacturing-based Quality/Food Safety personnel.
Hina brings diverse and innovative practical skills learned in a range of positions within the pharmaceutical and healthcare industries. She has over 17 years of experience in different areas of Quality Assurance and has worked with solid/liquid doses, medical devices and natural health products (cannabis). Hina has worked for many leading companies including: Shoppers Drug Mart, Apotex Incorporated and Baxter Corporation; and is currently working for Stanley Brothers Canada as their Quality Lead. As a results-oriented leader, Hina is able to effectively use her communication, analytical and management skills to drive companies forward.
Lead QA/QC Program Coordinator and Laboratory Manager – AAPS
Jason Chu is an experienced laboratory instructor at AAPS focusing on quality control and research and development functions in the pharmaceutical industry. He is an expert in HPLC, Dissolution, Pharmaceutical Laboratory Tests and GMP regulations. Beyond the classrooms at AAPS, he has led corporate training covering topics on WHMIS, health and safety, GMP regulations and data integrity.
Prior to joining AAPS, he was an Analytical Research and Development Chemist at Apotex Inc. – task with laboratory investigations, method validation, API screening and process validation support. During his time in R&D, he was appointed as a Designated Compliance Coordinator (DCC) to conduct regularly scheduled self-audits for continuous compliance improvement. At Apotex, he also held position as a Quality Control Chemist – testing raw materials, in-process products, finished products using a variety of laboratory techniques and instruments. In that role, he was also designated as a Subject Matter Expert (SME) task with responding to audit requests conducted by Health Canada and FDA.
Before starting his career at Apotex, Jason earned his B.Sc in Chemistry from York University (2008) and continued as a research assistant specializing in Synthetic and Analytical Inorganic Chemistry. His projects primarily focused on electrochemical reduction of CO2 to useful fuels and structure elucidation of novel complexes. During his time at York University, he taught various undergraduate laboratories in Organic, Inorganic, and Analytical Chemistry as a teaching assistant.
He brings with him wealth of teaching and GMP laboratory experience and a thorough understanding of process validation, cleaning validation testing, analytical techniques as well as regulatory requirements in the pharmaceutical industry.
Senior Food Safety and Quality Management Professional
Jatin is an accomplished Quality Assurance and Food Safety professional, with 25+ years of experience in the food industry. He is currently providing consulting to clients in food industries assisting them with process improvements, training, quality and food safety programs, second party and third-party audits, and is an instructor at AAPS.
Jatin has successfully developed and implemented Quality and Food Safety Management System (FSMS), process improvement, operational excellence, regulatory, auditing/inspection and training programs in various food product categories including dairy, ice cream, beverages, snack foods, sauces and condiments, spice blends, salad dressings, mayonnaises, canning of meat and non-meat products, bakery, dry-blending, roasting, slaughter and further processing of meat and poultry, partially and fully cooked breaded poultry products, fully cooked poultry products, pizza, burgers, lasagna, puff pastries, and IQF products.
His specialities include Regulatory Audits, Second and Third-Party Audits, GMPs, Preventative Control Programs, HACCP, New Product Development and Product Launch, Sensory Evaluation, Shelf Life Studies, Traceability and Product Recall Management, multi-zone Environmental Management programs, Allergen Management Programs, Food Defense and Food Fraud, Food Import and Distribution, Supplier Quality, Co-Packers/ Co-Manufacturers Quality Management, Supply Chain Quality Management, and Risk Management. Jatin has also worked on Continuous Improvement, Energy Management, Process Improvements and Lean Management, Total Quality Management (TQM), and Project Management in food industry.
Jatin hold number of industry recognized professional certifications including ASQ Certified HACCP Auditor (CHA), ASQ Certified Manager of Quality/Organizational Excellence (CMQ/OE), Certified Lean Six Sigma Green Belt, BRC Global Standards Lead Auditor. Jatin has worked with companies certificated to various industry leading Quality and Food Safety standards including HACCP, ISO 9000, ISO 14000, ISO 22000, SQF, and BRC.
Jatin is active member of various food industry associations including American Society for Quality, Institute of Food Technologists, and International Association of Food Protection. He brings with him wealth of experience in food processing, food quality, and food safety as well as regulatory requirements in the food industry.
Dr. John Eisenhoffer is a medical professional with over 22 years of pharmaceutical industry experience in Drug Safety, Medical Information, Clinical Research and Medical Liaison. As the Canadian Drug Safety Head he developed and directed a highly functional team to meet all compliance standards in Drug Safety and Medical Information Services to complete many successful Health Canada Audits. He has also directed drug development for Canadian products, managing Phase I-IV clinical studies with successful approvals from Health Canada. Dr. Eisenhoffer has mentored graduates and Health Care Professionals in Drug Safety and Clinical Research as well as providing scientific education to Sales, Marketing, and prescribing Health Care Professionals. He was the Scientific representative on many life cycle product teams and provided scientific review and approval of marketing material. He was also the Medical Reviewer for the International Signal Evaluation Group and authored Risk Management Plans and Periodic Benefit Risk Evaluation Reports to support Canadian products. He has a very strong scientific background with 17 published peer reviewed papers.
He received his Medical training in Europe, and a Masters of Science from University of Toronto.
Currently Dr. Eisenhoffer is an independent consultant for the pharma Industry focusing on drug safety and clinical research.
Director of Extractions / Head of Laboratories
Karen Quinto has seven years of microbiology and chemistry research before she entered the medical cannabis industry in 2016. She first began her career in extractions under Environment Canada’s Hazardous Air Pollution Lab, collecting air samples from over 150 sites for the United Nation’s Stockholm Convention mandate to monitor global hazardous air concentrations. This transitioned into her first cannabis extraction role at MedReleaf (where she and the extraction team won the 2017 Canadian Cannabis Award for Top High CBD Oil) and subsequently joining Weed Me Inc. as the Director of Extractions and Head of Laboratories. In a start-up setting, she has build the extraction, formulation, analytical lab, and post-production department from the ground up. She is also a certified Health and Safety committee member and has an extensive microbiology background prior to her career in the industry.
Science is not her only career path, as she also teaches extraction principles at AAPS and is currently an Industry Advisor for Ryerson University, where she received her BSc. prior to graduating from University of Toronto’s Masters of Environmental Science degree program in 2015. Her teaching roles range from tutoring children with autism, art, science as well as aiding Spanish speakers in English presentation translations. Her passion for connecting with her students make her one of AAPS’ vibrant and animated instructors as she makes complex scientific concepts understandable to a wide range of people from different career backgrounds using easily relatable concepts and analogies.
Kevin has over 25 years of pharmaceutical industry experience working for Novopharm Ltd. and Teva Canada Ltd. For 19 years, he was a supervisor in the following areas: Analytical Research and Development Stability, Quality Control Finished Product, Quality Control Stability, Quality Control Method Transfer, and Operational Excellence. Kevin is known as a positive person with an ability to motivate and guide people to reach their potential. He has demonstrated expertise in compliance, data integrity, laboratory investigations, root cause problem solving, recommending and implementing corrective and preventative actions (CAPAs), and continuous improvement of documentation and efficiency.
Kevin graduated from the University of Western Ontario with a M.Sc. in chemistry and has a yellow belt in Operational Excellence. In his spare time, Kevin enjoys long distance running.
I am a passionate and experienced food scientist with over 25 years of Canadian experience and expert level knowledge in pre-requisite and HACCP programs, GMP regulations, AIB standards, BRC and GFSI food safety procedures.
I have a diverse range of expertise in all aspects of food product development from research to market requirements to fulfill the ultimate objective of a commercially marketable product. My passion for teaching stems from the personal satisfaction I obtain by helping someone learn something new and the numerous benefits education brings to achieve better possibilities in career and personal growth.
National Regulatory Affairs and Quality Assurance Director Cardinal Health Canada
Mia Spiegelman was educated in Israel, Argentina and Toronto and holds a B.Sc. in Chemistry from York University and a Post Degree Certification if Pharmaceutical Regulatory Affairs and Quality Assurance from Seneca College. She brings to the table 11 years of experience in Generic Drugs, Medical Devices, Cosmetics and Natural Health Products. She has worked in various companies and has dealt with various product lines such as endoscopes, Dialysis Machines, Importation and distribution of all classed of regulated products as well Service Departments for the Medical field. Currently, she is a National Director for RA/QA in Canada’s leading and only national full service and value add distributor for Medical, Surgical and laboratory products – Cardinal Health Canada.
Mỹ (pronounced as May) Dang currently works at iVIK Holdings Ltd., an international cannabis pharmaceutical company. She began her career working in the biochemistry laboratory at Sunnybrook and Women’s Health Sciences Centre. Then, she moved to Montréal and has over 16 years’ experience in regulatory and quality assurance for various pharmaceutical companies covering human, animal health and cannabis products. Currently, she is VP and Board member of the Canadian Parents for French Ontario. Prior to this, she was an active member of CAPRA (Canadian Association of Professionals in Regulatory Affairs), taking on several leading roles including presenting webinars, Editor and Publication Officer of the NOC and eNOC publications and assisting with the CAPRA dinner meeting committee.
Pauline McGregor is a pharmaceutical consultant and owner of PMcG Consulting. She has thirty years’ experience in the Pharmaceutical industry and holds a Ph.D in chemistry. She is an expert in quality systems and procedures, GMP regulations and analytical chemistry. Pauline brings the experience and ability to customise and install the quality systems required to allow manufacturing and testing companies to operate to GMP regulations and review and improve on current quality systems to allow more efficient operations. She also brings a technical expertise to laboratories which enable her to assist them to develop analytical procedures, validate them and optimise efficiency with regards to laboratory operations in a QC environment.
Pauline has been involved with and has had a passionate interest in the evolution of method development, validation, transfer and verification of analytical methods and has been actively involved in authoring papers and presenting short talks and training courses on the application of QbD to analytical methods.
Pauline is currently a member of the Royal Society of Chemistry, UK and is listed on the RSC Directory of Consultants. She is also a proud member of the USP expert panel for Validation, Verification and Transfer of Analytical Procedures and is part of a USP Chemical Medicines expert committee.
Program Coordinator, Food Safety and Quality
Pirouz Yousefian has over 17 years experience in the food industry working in various positions such as plant and operations manager, PD and Quality Assurance manager. He has been teaching Quality Assurance, Food Processing, Food Plant Sanitation, and Food Chemistry in Ontario Colleges and Universities. He provides consulting and technical support to food and allied industries.
His previous employment includes: Seneca College, Centennial College, University of Ryerson, Max Soy Canada, Kisko Products and Novopharm. He holds a M.Sc. in Food Science from University of Guelph.
Mr. Rany Attalla has over twenty years of Pharmaceutical business, Sales, production and Quality Assurance experience in Canada and other parts of the world.
Rany has a strong understanding of regulations that pertains to Health Canada, FDA, ICH, EU MDD, ANVISA, CSA/UL, and ISO 9001/2015. Rany holds MBA specialization in Pharmaceutical management with a Degree in Veterinary Medicine. Also, Rany is a certified Quality Auditor from American Society for Quality (ASQ), Lead Auditor (TPECS) from British standards Institution (bsi). Rany is a Certified Black Belt Lean Six Sigma from Aveta Business Institute, USA.
Rany has been working as a Pharmaceutical Quality and Compliance Manager in different Multinational Pharmaceutical companies and also as Independent GMP & Auditing Consultant.
Mr. Rishi Mehta has over 5 years of experience working in Regulatory Affairs & Quality Assurance for both Medical Devices and Pharmaceutical Industry.
Rishi holds a Bachelor of Science from the University of Waterloo, and also holds a Graduate Certificate in Regulatory Affairs from Humber College. Rishi has a strong understanding of Health Canada, FDA, and EU Regulations. Rishi also holds a RAC from the the Regulatory Affairs Certification Board (by RAPS), and is also an ISO 13485:2016 Lead Auditor (TPECS).
Senior Manager, Scientific Affairs
Roksana Kadivar is the Senior Scientific Affairs Manager at Galderma Pharmaceutical Inc., which is the world’s largest independent global dermatology company.
I am an analytical chemist with several years of work experience in industries and academia. During my tenure in different laboratories, I gained experiences in HPLC (with various types of detectors) method development for analyzing various types of pharmaceutical and non-pharmaceutical organic compounds. In addition to HPLC, I also became experienced in other type of analytical techniques that support pharma industries. Working in fully regulated companies over 10 years helped me gaining hands on experiences in quality systems, FDA, EU and Health Canada regulations, GMP and GLP compliances. My main focuses working in the pharma R&D lab are: method development, method transfer, method validation, unknown identification in drug substances/product, impurity profiling, writing (scientific report, protocol, SOP) and reviewing (data and documents).
I obtained my PhD in Chemistry from Queen’s University, Kingston, Ontario in 2002. After finishing my degree, I have done academic (McGill) and industrial post doctoral (Pulp and Paper Research Institute, QC) fellowship. Followed by, I worked in pharmaceutical company (Siegfried, QC), Pharmaceutical Science division in a CRO (Exova, ON) and Environment Canada (Burlington, ON) as a scientist. Currently, I am working as a document reviewer at Bimeda MTC Animal Health, Cambridge, ON, where my role span from reviewing laboratory generated raw data to preparing documents for regulatory submission.
Prior to PhD enrollment, I was teaching in undergraduate level at Shahjalaj University of Science and Technology (SUST), in my home country Bangladesh, for 2 years after completing my Masters and B.Sc. from the Department of Chemistry, Dhaka University, Bangladesh.
In addition my teaching experience at SUST, I also taught undergraduate students, both in lab and classroom, while I was at Queen’s. I supervised undergraduate students during my PhD, at McGill and Environment Canada. My passion for teaching remained with me and I am happy to be an instructor at AAPS.
Consultant CEO-RegStrat Consulting Inc. Canada
Sanyukta Kher, worked as the Vice President Cronos Group for the past two years, until Dec 2020 and is currently working as a Consultant for Cronos. Prior to that, she worked as the Director of Global Regulatory Affairs for Apobiolox (Apotex Inc.), one of the leading biopharmaceutical companies in Canada. With 25 years of experience in biopharmaceutical industry in India and Canada; she was with Apotex for 8 years.
After receiving her microbiology degree from the University of Pune, India, she has trained in Regulatory Affairs. She also has a post graduate degree in Computer Science and Master of Arts in English.
She has worked at Serum Institute of India Pune as a Microbiologist in the Quality Control Department working with human therapeutic proteins, bacterial and viral vaccines. After moving to Canada in 2000, Ms Kher has occupied many and varied positions, scientific and managerial. She has worked in the pharmaceutical industry as well as a consultant at DSA Consultants in Canada.
Amongst relevant accomplishments, she has worked with global regulatory agencies and has been responsible for several successful applications for human drugs, biologics, devices and veterinary drugs.
She has been instrumental in developing regulatory strategies which were accepted by regulatory agencies and resulted in successful filings.
In her role as Director with Apotex Inc., Ms Kher has been instrumental in filings of biosimilar applications to the three major regulatory agencies (EU, HC and the FDA).
In her role as VP of Cronos, she was responsible in setting up GMP compliant sites, globally, including, Canada, US, EU and Israel and achieve product licenses in all of these regions for Cronos products.
She is a member of TOPRA; was an active member representing Apotex Inc. on the biosimilars committee at the IGPA and CGPA and an instructor (teaching International RA) at the Seneca College, Toronto.
Ms. Kher is very interested in the regulatory and clinical issues regarding drugs, biologics and medical devices. This interest has included active participation in providing feedback and comments to the regulatory agencies (EU, HC, FDA and TGA) on biopharmaceutical and cannabis guidance’s and regulations.
AAPS – Instructor
Sase Boyo has over 15 years’ experience in Clinical Research; this experience includes Clinical Trials’ Phases 1- 4 in Pharmaceutical and Biotech Clinical Development – with core work in Clinical Project Management and Clinical Operations. Ms. Boyo oversees all aspects of Clinical Trials – Protocol and Standard Operating Procedures (SOPs) Development, Risk Assessment and Management, Clinical Compliance and Monitoring, Clinical Research Regulations, Good Clinical Practice Adherence, Data Management and Reporting, and Pharmacovigilance.
Ms. Boyo has a Bachelor’s Degree in Biology from California State University, Northridge, a Master’s Degree in Clinical Research from Morehouse School of Medicine and a Master’s Degree in Public Administration from Kennesaw State University. Ms. Boyo is also a certified Project Management Professional (PMP) with the Project Management Institute (PMI).
Director of QA/QC – Experchem Laboratories Inc.
A Chartered Chemist, her career spans 30 years in the pharmaceutical industry. She started as a stability chemist at Sterling Drug and soon moved to Health Canada where she worked over 13 years in various capacities with the Health Product Branch Inspectorate (HPBI) in the Ontario region. Her expertise include Medical Devices Inspection, Drug GMP Inspection and Compliance issues. She is currently the director of QA/QC at Experchem Laboratories Inc. where she is responsible for overseeing and maintaining the GMP compliance of the chemistry and microbiology laboratory, Auditing, and providing Quality Control Services to importers and distributors.
She has a degree in chemistry from York University and a diploma in Pharmaceutical Chemical Technology from Seneca College.
Tigran Uzunyan is a medical doctor and research scientist with over 18 years of diversified experience in academia, pharmaceutical industry and clinical research. Tigran acquired a degree of medical doctor and then specialized in clinical pharmacology in Yerevan, Armenia. In 2008 he defended his PhD thesis in pharmacology.
Tigran Uzunyan has an extensive experience in drug development and regulation under various jurisdictions, designing and conducting early phase (bioequivalence, bioavailability, first in human, etc.) and late phase (II to IV) clinical and observational studies. He also managed medical cannabis development research projects in Canada.
Vicky has a background in Applied Science, Quality Assurance and Regulatory Affairs.
Four years ago, she joined AAPS as a QA/RA Consultant. Since then, she has worked with many applicants towards their licence applications, licence amendments, etc. She has also set up quality systems from scratch, written SOPs, developed Hazard Analyses and Preventive Control Plans for various pharma and cannabis clients.
In addition to these, Vicky has performed Gap analyses and prepared various facilities for Health Canada and other regulatory audits. Vicky is passionate about quality and aims to help clients improve their operations, avoid pitfalls, detect compliance issues early, and stick to GPP, GMP and other standards, as applicable.