Continuing Education
Center for Applied Health SciencesAdditional Courses in Risk Management |
| Risk Management for Health Care Products & Processes Product Quality Risk Management Tools, Standards, & Guidelines (Track 1) Application of Risk Management Tools (Track 2) Medical Devices (Track 3) Clinical Risks for Medication Use: Pharmaceuticals & Biologics (Track 4) • Gain proficiency in a system approach to total life cycle risk management for health care products (medical devices, pharmaceuticals, biologics, nutraceuticals, and foods); • Learn the skills and tools necessary to optimize the safety of healthcare product manufacturing and utilization; and • Learn at your convenience with flexible scheduling and location options. Currently Scheduled Courses: Track 1 - Product Quality Risk Management Tools, Standards, and Guidelines July 21-23, 2008 - A System Approach to Risk Management (3 days) This course provides a practical approach to implementation of a risk management system that integrates all elements within a quality management system. It covers the system approach to risk management based on the latest international standards and guidance documents, and their applications. Participants will learn key success factors for effective risk management and a total life cycle risk management model based on the WHO, ISO, ICH, GHTF, and other industry standards such as oil and chemical, aerospace and ground transportation models. July 24-25, 2008 - International Standards & Guidance for Pharmaceutical and Device Product Quality (2 days) This course discusses the relevant regulatory requirements and standards for medical products (pharmaceuticals, medical devices and combination drug/devices) with a focus on how to integrate risk management within a quality management system. Participants will learn the safety requirements of the pharmaceutical regulations of both the US and the EU, relevant ICH Guidance such as Q7, Q8, Q9, & Q10, EU MDD, US FDA Quality System Regulation, relevant GHTF Guidance documents, ISO 13485 & ISO 14971 Standards. The course identifies the key elements of risk management and their relationships to an efficient business model in the context of international standards and guidance. Track 2 - Application of Risk Management Tools July 28-30, 2008 - Applications of Risk Management Tools & Techniques for Health Care Product Manufacture & Use (2.5 days) This course focuses on real problem solving and advice. Participants are advised to bring relevant examples with them for class discussion. In addition to a survey of the most common tools and techniques for risk management, it also presents how to facilitate risk assessments and form a cross-functional team. Participants will learn the elements of intended use/purpose analysis, functional analysis, fault tree analysis, hazard analysis and critical control points, hazard and operability study, failure mode and effects analysis. Participants are required to work on the application of these tools and techniques to demonstrate the effectiveness of their integration. The course is structured to facilitate hands-on workshops to master these tools and techniques. Participants will be organized to work as a team on a health care product, and learn how to apply these tools and techniques correctly and effectively. The team project is required for participants seeking the certificate. Enrollment Details Tuition: $450 per course-day. This cost will include all course materials, plus mid-morning and mid-afternoon refreshment breaks. All courses run from 8am - 5pm on full days, and 8am - 12pm on half days. Location: These courses will take place at 9890 Research Drive, Suite 100, in Irvine, CA. On-site courses may also be brought to your location. Download the registration form to register. For More Information: contact Tony C. Chan by phone +1-714-318-3138, or by e-mail - chant@vt.edu |
