Joseph Wu

Professional Info

Joseph Wu

Principal Consultant

Over twenty eight years of successful varied and practical experience in working with industry ranging from biotechnology, biopharmaceuticals, pharmaceutical, medical devices, diagnostics to Natural Health Products (neutraceuticals), veterinary, personal care machining and plastics • Experienced in the Implementation of Quality Management Systems for a diverse client base. • Directed and managed corporate divisional and departmental groups supervising up to 30 employees. • Directed and managed all aspects of quality assurance and regulatory compliance in the manufacture, distribution and post market surveillance of biopharmaceuticals, in-vitro diagnostics, bulk supplies, and clinical supplies.
• Managed, facilitated and hosted several successful licensing and annual regulatory inspections by regulatory agencies including; United States (FDA), Health Canada, UK, Germany and Saudi Arabia. • Experienced in the implementation and execution of quality programs to support product development including data trending, internal audits, personnel training, CAPA, etc. Joseph Wu has served as the Quality Assurance Person and implemented Quality Assurance Programs, Quality Control Programs for many organizations. In response to Canada’s Marihuana (Marijuana) for Medical Purposes regulations (MMPR), Joseph Wu is qualified to serve as Quality Assurance Person in support of Marihuana for Medical Purposes Production.
Degree
University of Alberta – MS, Biochemistry University of Aberdeen – BSc, Biochemistry
Experience
Consultant – Radient Technologies Inc Consultant – Sembiosys Genetics Inc Consultant, Director Operations and Quality – BioPak Limited Director Quality – QSV Biologics Pharmascience Consultant – Pharmascience Consultant – Kamada Director, Quality – KS Avicenna Director, Quality Assurance  – Cangene Corporation Director, Quality Assurance – Biomira Inc. Manager, Regulatory Compliance – ChemBioMed Ltd
Contact info

Areas of activity

Implementation and Maintenance of Quality Management Systems for regulations and standards including:

  • Good Manufacturing Practice Regulations (Canada, USA, EU, ICH)
  • Marihuana (Marijauna) for Medical Purposes (MMRP)
  • Medical Device Regulations
  • Quality Systems Regulations (QSR)
  • Natural Health Products Regulations (Dietary Supplements – US)
  • ISO9001:2008
  • ISO13484:2003
  • ISO17025:2005
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