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Xuefeng Yu,
PhD, is
Director, Bacterial Upstream Process
Development, Sanofi Pasteur Ltd.,
Toronto, Ont. Canada and Corporate
Platform leader, Bacterial Upstream,
Process Development, Sanofi Pasteur
Corporate. He obtained his doctorate in
fermentation biotechnology from
Macdonald Campus of McGill University,
Ste Anne de Bellevue, Quebec, Canada. He
is also the
Representative of Sanofi Pasteur’s to
“Cell-Factory Bioprocessing Network”
(Cell-Net), a country wide research
network funded by Natural Sciences and
Engineering Research Council (NESRC) and
industrial partners and the member of
industrial advisory board of Biomedical
Engineering program, McMaster
University. Xuefeng has 20 years of
extensive experience in vaccine process
development, process scale-up and
transfer, GMP production facility
management, new technology development
and implementation, validation project
for new cell culture and viral vaccine
process development facility and
equipment validation.
Maja Mrkic,
M. Sc. Chem, is Manger, GMP Compliance,
at PharmEng Technology Inc. She has an
extensive background in Quality
Assurance, Audits, Master Validation
planning, Drug Master File and Site
Reference file preparation coupled with
development and implementation of GMP
programs. She has experience in
different areas of
validation/qualification: equipment,
thermal processes, utilities, and
retrospective validation of computerized
system and legacy equipment to ensure
compliance. She is well versed in GMP
requirements (TPP/FDA/ICH/WHO
guidelines) and compliance regulations
for pharmaceuticals, biologicals, and
active pharmaceutical ingredients.
Craig Lee,
PhD, is Associate Director, Wyeth
Pharmaceuticals, Biotech Division. He
obtained his Doctorate in chemical
engineering from Syracuse University. He
has the professional experience with
over 20 years in biotechnology and
manufacturing industries, covering
facilities, equipments, cleaning,
processes, documents, sterile filling
and automations validation. Craig also
has been the former project manager,
engineering manager and engineering
supervisor of biotechnology in Bayer
Corporation, production specialist,
general supervisor and senior chemical
engineer of Bushy Park Plant in Bayer
Corporation, and the senior scientist of
Recra Environmental Inc.
Peter Doherty,
B.Sc. is a Senior GMP / Validation
Consultant with PharmEng Technology Inc.
He has over ten years of experience in
the pharmaceutical and custom
manufacturing industries, covering
computer validation, stability, and
quality control programs. His experience
includes implementation of projects to
ensure regulatory compliance of computer
systems and laboratory standards. He
has experience in the preparation and
execution of IQ and OQ protocols for
laboratory equipment, building
monitoring systems and in-process
control, and computerized systems. He is
well versed with 21 CFR Part 11
compliance requirements.
Nader Moslemian,
P.Eng, B.Sc. Mechanical Engineering, is
the Director of Engineering & Metrology
at PharmEng Technology Inc. He is highly
experienced in preparing and executing
installation, operation and
performance/process qualification
protocols for pharmaceutical systems. He
has an in-depth knowledge of engineering
and evaluation of facility and process
expansion requirements for manufacturing
and laboratory facilities. He is highly
skilled and experienced in computerized
design, calculation, operating cost and
energy management analysis of building
utility systems. |
