How to Implement Risk Management Principles and Activities within A Quality Management System

Risk management is a practice with processes, methods, and tools for managing risks in a project. It provides a disciplined environment for proactive decision making to continuously assess what could go wrong within an organization and with its products. This course will cover which risks are important to deal with and how the implementation of strategies can mitigate risks. Additionally, the curriculum provides attendees with the skills to use, maintain, and extend the functionality of a risk management system by effectively analyzing and producing firm-wide risk management tools and measures.

Specifically, this training will teach and reinforce the skills needed to acquire data from disparate data sources, configure your risk environment, develop appropriate risk factor models, perform risk analysis and create results-based reports.

Topics cover current US and international regulatory requirements with respect to development and implementation of effective risk management. A focus will be placed on basic regulation and the Global Harmonization Task Force’s recent supplemental guideline on "Implementation of Risk Management Principles and Activities within a Quality Management System"

Among the topics to be discussed are: FMEA (Failure Modes and Effects Analysis), FTA (Fault Tree Analysis, and HACCP (Hazard Analysis and Critical control Points). These will be applied to both products and processes and extended to include the application of risk management to a Quality Management System. The QMS elements include Corrective and Preventive Action, Supplier Management, Change Control, Complaints, Internal Audits, and Design and Development including Verification and Validation.

This course will also provide participants with a systematic approach for recognizing potential failure modes and analyzing effects for product design and manufacturing processes. Once potential failure modes have been identified a process FMEA can be used to identify the level of validation testing.

This course has been pre-approved by the Regulatory Affairs Professionals Society (RAPS) as eligible for 12 credits towards a participant's RAC recertification upon full completion.

Gordon Wehner is President of QualMed. QualMed works with both small, entrepreneurial firms and large, well-established medical-device and pharmaceutical organizations regarding audits, gap assessments, Good Distribution Practices, WEEE, RoHS and Supplier Management in Canada, the United States and Europe.

With nearly 25 years of experience in Quality Assurance, Regulatory and Clinical Affairs in the medical device and pharmaceutical industries; Mr. Wehner has worked with organizations both small and large – including four start-up organizations – to improve or establish quality management systems.

Mr. Wehner has an in-depth understanding of Canadian, US and international regulations for medical devices and pharmaceuticals; including ISO 13485:2003, ISO 14971:2007 and FDA Quality System Regulations. This experience includes the European Medical Device Directive – as well as Canadian, US and International GMPs. He has been directly involved in several design and development projects that include the application of Risk Management and Process Validation.

Mr. Wehner received his MSc in Biology from the University of Waterloo and his HBSc in Biology and MBA in Operations Strategy from Wilfrid Laurier University.