Guest Speaker: Tony Chan, Professor & Director, Risk Management Programs, Virginia Tech University, Center for Applied Health Sciences
Successful health product manufacturers should have preventive programs to determine process or product deficiencies and prevent mishaps. Identifying process or product issues through formalized audits would be effective only if auditing techniques and tools were applied appropriately. Traditional auditing strategies such as FDA's QSIT or the Six-System Approach are usually employed but resource intensive and do not always focus on the direct impact to product safety.
At the end of this seminar, you will gain insights on the following:
- Strengths and weaknesses of some auditing approaches;
- How to apply these approaches;
- A risk-based audit approach integrated with a comprehensive risk management system;
- How to streamline audits and address key safety issues; and
- A cohesive risk information system.
Attend this webinar to learn:
How to apply risk based principles to auditing which focus on public safety and reduce resource intensity and cost.
Your Speaker: Mr. Tony C. Chan, MBA, MSQA, MS Reg. Sc., is Professor and Director of Risk Management Programs at Virginia Tech's newly formed Center for Applied Health Sciences. He is involved heavily with risk management standard activities for medical products both nationally and internationally. His work includes the research, development, training, and implementation of risk, quality and compliance management systems, system approach to total life cycle risk management, hazard analysis and critical control point programs, and a unified enterprise risk management. One of his latest efforts is working with healthcare facilities to prevent medical and medication errors. He has nearly thirty years of experience in the fields of quality and reliability engineering in various industries including pharmaceuticals, biological products, ophthalmic products, combination medical products, medical devices, in-vitro diagnostic devices, pathology laboratory equipment, computers, consumer electronics, and aircraft engineering. Mr. Chan has been involving in training and consulting for both American and Asian medical product industries which include mature and start-up companies as well as institutions such as the US FDA Staff College, Association for the Advancement of Medical Instrumentation (AAMI), Advanced Medical Technology Association (AdvaMed), Beijing Hua Guang Certification of Medical Devices Co. Ltd. (CMD), Hong Kong Productivity Council (HKPC), Taiwan Industrial Technology Research Institute (ITRI), Taiwan Parenteral Drug Association (TPDA), and Enhealth Sdn Bhd., Malaysia.