QiQ’s philosophy is to help your company culture become “Do it once, do it right”. In some organizations this may merely be a tune-up or course correction, in others it’s a paradigm shift. Regardless of the extent of the deployment quality management practices your organization, QiQ can assist to align, realign and coach your organization through change. QiQ’s will facilitate the implementation of quality tools such as Quality Assurance, Quality Control, Quality Policies, CAPA, Standard Operating Procedures, Root Cause Analysis, Process Monitoring, etc. in your Quality Management System (QMS) and transfer the process to your organization’s knowledge base so your company becomes self sufficient once QiQ's job is done.
The company is owned and managed by Joseph Wu. A Biochemist (MSc) by training, Joseph Wu has worked extensively with clients in diverse industries including; Manufacture of Pharmaceutical, Biopharmaceutical, Natural Health Products, and Veterinary Drugs; Primary Healthcare, Machining, and Plastics Fabrication; coaching in the implementation of processes for compliance with ISO Standards (QMS) and Good Manufacturing Practices (GMP). He has worked with small and large companies across Canada, US, UK and the Middle East. His clients have ranged from service providers to the manufacturers of highly regulated injectable therapeutic drugs, medical devices and chemicals to plastics. With his extensinve industry experience, Joseph has successfully liaised with, and directed company interactions with regulatory agencies from the European Union (UK, Germany), USA and Canada. He is conversant with standards and regulations including; Good Manufacturing Practice Regulations (Canada, USA, EU, ICH), Marihuana (Marijauna) for Medical Purposes (MMRP), Natural Health Products Regulations (Dietary Supplements - US), Medical Device Regulations (ISO 13485), and Quality Systems Regulations (QSR).
A typical project involves an analysis of your workflow to determine your GAPs, nonconformances or shortfalls followed by mapping of your workflow processes to understand your process control parameters and performance limits. These are then supported with the Quality Tools, policies and procedures and training to address the GAPS, nonconformances or shortfalls.
In doing it once and doing right, QiQ coaches your organization through the identification, design and implementation of a QMS program. Owner, Joseph Wu has the experience and expertise to coach and assist your organization through the management of quality involving the four main elements; Quality Planning, Quality Control, Quality Assurance, Quality Improvement.
•Workflow/GAP Analysis •Process Mapping •Quality Process Identification and Implementation
GMP regulations specify expectation (the WHAT) of the agencies responsible for enforcement of the act but they do not cover the process to comply (the HOW). QiQ can assist and coach you through the implementation of a GMP compliant Quality Management system. Joseph Wu has over 28 years of experience in the industry and has specific content knowledge in the Six System approach to Quality Management.
•Design and implementation of Quality Management Systems •Assistance with preparation and review of CMC regulatory submissions •Training •Validation program and implementation •Audits •Quality Assurance