Why Our Professional Training?

INSTRUCTORS

Pharm Eng Instructors are subject matter experts and recognized leaders in their specific fields. Instructors are chosen based on their knowledge and skillset.

Jack Basarke

Jack Basarke, B.Sc (Chemistry), DPHI (C). 34 years experience with Health Canada in drug GMP inspections and investigations, including 15 years as Drug GMP Head. Developed and wrote GMP related guidelines; Group Leader and Technical Advisor of GMP’s for the Mutual Recognition Agreement process with the European Community; Expertise in Canadian, US and European cGMP for Drugs (Human / Veterinary) and Devices. Expertise in GMP / GLP inspections for drugs, biologics, cosmetics and devices; GCP inspections and Pre-approval inspection on behalf of FDA

YC Lee

Dr. Y.C Lee, B.Sc. Chemistry., Ph.d Physical Organic Chemistry (HK), Dr YC Lee was a Manager in the Lilly Analytical Research Laboratory at Eli Lilly & Company and was a Director of Analytical Development at Patheon. His laboratories were responsible for the development of more than 40 new chemical entities (NCE) for global regulatory submissions for commercial production. Dr Lee founded PharmLink Inc. at York University (Canada) in 2005. PharmLink offered comprehensive consulting services to its pharmaceutical clients in compliance and R&D. Recently, PharmLink has joined the PharmEng family and become PharmEng Innovations. Dr YC Lee is now a Senior Director of PharmEng Innovations. Dr. YC Lee has more than 19 years of pharmaceutical development experience in analytical development, validation, experimental design, drug product specifications and stability testing. He is an editor of the book “Analytical Method Validation and Instrument Performance Verification” published by Wiley. Dr Lee is also a founder of the Calibration & Validation Group (CVG). CVG is a non-profit organization formed by more than 1,500 analytical and formulation scientists from the pharmaceutical and chemical industries, academia and government agencies across Canada.

Fenton Fong

Fenton Fong, MSc, is a Senior Consultant and has fifteen years of work experience in manufacturing and process development for biotech, pharma and natural health products (NHPs). He has a combination of expertise and knowledge in many aspects of GMP manufacturing, Quality Assurance and Regulatory requirements for small molecule, biologic therapeutics and NHPs. Fenton has inter-disciplinary experience spanning molecular biology to biochemical engineering. He is very knowledgeable of the drug development life cycle, regulatory guidelines and pharmaceutical manufacturing technologies. He has carried this expertise into the newly regulated NHP industry and helped many clients to become compliant with Regulatory and GMP requirements.

John Cobby

John Cobby, founder of GALENOS, obtained his Doctorate in Pharmacy specializing in Pharmacokinetics and Bioavailability. John held various management positions in medical functions at three multinational healthcare organizations over 17 years, where he had responsibilities in clinical development and regulatory affairs. His experience also encompasses drug safety, medical information, review of promotional materials, and scientific support for marketing and sales functions. He was treasurer of the Medical R&D Section of Canada’s Research–Based Pharmaceutical Companies and served on various committees. He founded, and is an honorary lifetime member of, the Canadian Association of Professional Regulatory Affairs.

Peter Doherty

Peter Doherty, B.Sc. Biochemistry Sixteen years experience in the pharmaceutical / biotech industries, encompassing computer validation, method validation, instrument validation, and stability / quality control programs. Experience assuring regulatory compliance of laboratory systems and laboratory methods. Preparation and execution of protocols for laboratory equipment, environmental monitoring systems and process control systems.

Ian Hart

Ian Hart, M.B.A., B.Sc. is the Senior Director of Vaccine Manufacturing and Facilities of Nabi Biopharmaceuticals. Ian has over 16 years of experience in the pharmaceutical industry under Canadian, US and European cGMPs. He has held positions of increasing responsibility at Sanofi Pasteur Limited in Vaccine Manufacturing, Validation, Quality Assurance and Manufacturing Technology in Toronto, Canada and Lyon, France. Throughout his career, Ian has successfully led and participated in the design, scale-up, validation and licensing of several viral and bacterial vaccine manufacturing facilities.

Ravi Joshi

Ravi Joshi, B.Sc. Chemistry, President of PharmEng Technology Inc. He has 27 years of experience in Administration, Product Development, Validation and Quality Assurance within the Pharmaceutical & Biotechnology Industry. He is an innovative strategist skilled at assessing and implementing cost effective solutions with effective training, and technology transfer. He has successfully obtained FDA accreditation for pharmaceutical manufacturing facilities. He has experience in master validation plan, drug master file, internal and external audit program, manufacturing process control.

Alan Kwong

Alan Kwong, B.Sc P.Eng., M.Sc., M.B.A., Founder and CEO of PharmEng International Inc. Over 20 years of experience in the pharmaceutical industry with solid expertise in system integration and design of pharmaceutical and biotech facilities, equipment and processes, feasibility studies, engineering, procurement, construction, project management, process optimization, production, quality assurance, validation, and cGMP compliance. Diversified experience in designing, building and validating solid dosage, topical, aseptic, sterile, biotechnology, biologic and blood products, and active pharmaceutical ingredients plants. Was Program Director for a certificate program in “Biotechnology and Pharmaceutical Technology” at the University of Toronto. Author of two chapters on “Facility, Process and Equipment Optimization” in a book entitled “GMP Compliance, Productivity and Quality.”

Nader Moslemian

Nader Moslemian, B.Sc. P.Eng In-depth knowledge of engineering evaluation of facility and process expansion requirement for pharmaceutical manufacturing and laboratory facilities. Extensively knowledgeable in HVAC, Building Management, Purified Water, Pure Steam, Refrigeration, and Plumbing systems. Highly skilled and experienced in computerized design, calculation, operating cost and energy management analysis of building utility systems. Expert in preparing and executing installation, operational and performance/process qualification protocols for pharmaceutical utility and process systems. Advanced knowledge of AutoCAD, MS-Office and MS-Project. Strong project management, leadership, interpersonal skills, and committed to teamwork.

Maja Mrkic

Maja Mrkic, M.Sc. Chem, B.Sc., Eng., PMP Technical and management project experience with pharmaceutical, biotech, API and medical device companies. Extensive background in Quality Assurance, Audits, Master Validation planning, Drug Master File and Site Reference file preparation. Validation/qualification expertise: equipment, thermal processes, analytical method transfer, utilities, and retrospective validation of computerized system and legacy equipment to ensure compliance. Well versed in GMP requirements (HC/FDA/ICH/WHO guidelines) and compliance regulations for pharmaceuticals, biologicals, and active pharmaceutical ingredients and medical devices.

Sinisa Petrovic

Sinisa Petrovic, B.Sc.E.E. Project Manager with over ten years of experience with broad range of computerized systems, including client-server computer systems, computerized control and monitoring systems, laboratory systems and computer networks. Accomplishments include validation of systems, software and equipment, delivery of Computer Systems Validation courses, development and implementation of hardware and software components. Provided various validation services including project management, assessments (GxP, Risk, Part 11), remediation, development and execution of qualification protocols, configuration, testing, technical support, troubleshooting, commissioning and training.

Lorraine Woo

Lorraine Woo, P.Eng Chemical Engineering A client-focused professional with extensive pharmaceutical experience, focusing on business systems implementation and process design for Research and Development groups and QC / Stability laboratories. Major strengths and experiences include process design; project management; and validation planning and execution

Jerry Holatko

Jerry Holatko B. Sc. Chem. Seasoned senior manager with over 30 years experience in regulatory positions with Health Canada and PharmEng Technology Inc- Regulatory and Consultant Services. Accomplished in management, auditing, training, coaching, analytical analysis, inspecting and investigation of issues involving all dosage forms and commodities regulated under the Food and Drugs Act and regulations – i.e. Pharmaceuticals , cosmetics, medical devices and blood ,tissues, organs and xenographs (BTOX).

Nicole La Rue

Nicole La Rue, B.Sc. Microbiology Practical knowledge of current Good Manufacturing Practices (cGMP) and Good Laboratory Practices (GLP) with related experience in Quality Assurance (QA) including experimental protocol and standard operating procedure (SOP) development, execution and review. Comprehensive background knowledge in data analysis, microbiology and cell culture techniques. Four (4) year experience in the biopharmaceuticals industry.

David Coffin-Beach

David Coffin-Beach, B.Sc. Pharm, Ph.D. President, Gilberts ATP specialized in delivering strategic, technical, marketing and management services to pharmaceutical manufacturers and investors around the globe. He formerly held the position of President of TorPharm Inc. (Apotex Company). He began his career in pharmaceuticals as a practicing pharmacist and then obtained his Ph.D in pharmaceutics. His progressive career moved from a starting position as a Development Scientist with Endo Laboratories, culminated in a Director position with Schering–Plough prior to immigrating to Canada. He authored scientific articles, which have been published in peer-reviewed journals, is a co-author of a text chapter on Pharmaceutical Development, and holds several U.S. patents.

Ben Lee

P. Eng., B.Sc., I.E. Over 20 years experience in all aspects of Project Management and Industrial Engineering Experience. Timely and cost effective delivery of over $360,000,000 in major projects in the Biotechnology, pharmaceutical, hospital and manufacturing sectors from concept to completion. Comprehensive knowledge and practice of FDA’s CFR 21 Part 210/211, 600, and Part 11 and Health Canada’s current Good Manufacturing Practices (cGMP) and Good Laboratory Practices (GLP). Direct experience in project planning such as process flow analysis, process improvements, optimization, just-in-time manufacturing, lean manufacturing, benefit cost analysis, life cycle costing, feasibility studies, change control, operational/technical requirements computerized. Extensive experience in functional programming, space programming, land use and environmental approvals, project budgeting, scheduling, resource planning, design, construction, commissioning and validation.

John R. Markus

Senor Pharmaceutical Consultant. Posses over 44 years of experience in the drug regulatory area with 30 years in FDA and 14 years as a GMP/regulatory consultant. Mr. Markus has served as an Analytical Chemist in the Cincinnati field laboratory, Chief Chemist of the review and approval for the CMC (Chemistry Manufacturing and Control) sections of animal drug applications and drug master files.