Course Description - Course runs 9:00 to 5:00 both days (Breakfast & Lunch Included)

The regulatory and business requirements for the pharma, diagnostics, and medical-device fields continue to update, blend, overlap, and blur. With these changes, the importance of risk assessment—and risk management—gains higher business and regulatory significance. It now becomes even more important for professionals in these fields to recognize, accept, understand, and respond to these changes —particularly since new regulatory requirements have emerged within this changing environment.

The market’s Tolerance for Failure of Drugs, Devices, and IVDs has reduced significantly in recent decades. This reduction reflects a general loss of confidence in the medical industry. The adoption of formal Quality Management Systems (QMS) has recovered some of that confidence, but we must still do more. This course addresses what we can do.

When integrated with QMS—the collection of policies, procedures, processes, and resources designed to meet customer and regulatory requirements—risk management approaches and requirements can help further build confidence for the major stakeholders; including regulators, industry, and–most importantly–users and patients in the medical community.

Items covered include risk-management and QMS principles—as well as associated standards, and practices. The course addresses how to develop, apply, and implement risk management strategies within a QMS—helping reduce risk associated with drugs, devices, IVDs, and even business practices themselves.

Topics include:

• Impact of revised International Standards Organization (ISO) standards 13485, 14971
• Specific review and assessment of ISO 13485:2016 and the three-year transition period
• Other current and emerging U.S./international regulatory requirements
• Definitions of standards, regulations, and laws—as well as instances in which these may overlap
• Review and application to pharma of International Council for Harmonization (ICH) Q8, Q9, Q10
• International Medical Device Regulators Forum (IMDRF)—previously known as the Global Harmonization Task Force—Medical Device Risk Management principles within QMS
• Risk-based approaches for assessment of In-Vitro Diagnostics
• Review of the ISO 31000 definition of “risk” and potential application to business practices

This course examines similarities between the role of ICH in pharma and that of IMDRF in medical devices—including how regulations apply to emerging combination devices. It also identifies links between Risk Management and QMS, including Design Controls, Preventive/Corrective Action, Supplier Management, Change Control, Complaint Handling, and Production/Process Control.

Who Should Attend

This two-day course is designed for quality/production managers, engineers, auditors, regulatory/quality professionals, clinical/product specialists, R&D engineers, laboratory professionals, product-development professionals, and management. Those responsible for Quality System compliance and certification to ISO 13485 are urged to attend. Attendees will learn the value of risk-management principles, integration with QMS, and how to better utilize resources.

This program provides a broad introduction to risk management for both new and experienced personnel, including management. It establishes awareness and understanding of the advantages of integrating QMS and Risk Management. Attendees will learn how to enhance the sustainability of product and business by improving patient safety, clinical outcomes, and business predictability. In workshop exercises applying those principals, participants will broaden and update their knowledge of both U.S. and international risk-management requirements.

Jonathan Lee

Jonathan Lee

Specialties: Regulatory

Jonathan Lee has more than 25 years of broad-based medical device experience with extensive Quality System experience encompassing ISO, MDD & GMP standards and regulations, through consulting and senior management positions in QA/RA, R&D, Project Management, Product Management, and Product Introduction disciplines, in both the United States and Australia.

A multiple patent holder, Mr. Lee’s prior roles include VP R&D at Cardiac Control Systems, Vice President Quality, Regulatory & Clinical affairs at Medtronic. In addition, his consulting roles supporting implantable bio stimulation telemetry systems, implantable heart sub-system, catheter defibrillation system, surgical tool, vertebral stiffness measuring system, respiratory interfaces, cardiac catheter development, medical device process V&V, quality system development & implementation, and product approvals, have provided for an extensive accumulated experience.

Today, as Principal Consultant and Managing Member of “MedDev Consulting Solutions International” he provides strategic direction and tactical solutions for unique medical device challenges. Including areas such as integration of quality systems with compliance, product performance and elevated stakeholder expectations.

Mr. Lee holds an Electrical Engineering (Biomedical) BE degree from the University of NSW in Australia with post graduate work in Computer Studies at the same University. He has participated in compliance symposia at Harvard University and served as an instructor on quality systems at University of Southern California School of Pharmacy Master’s Degree Program.

Other Courses:

• Medical Devices: Developing Effective Post Market Surveillance and Complaint Handling Systems
• Medical Devices: EU Directives, Guidance, CE Marking and ISO Standard Certifications
• Medical Device Process Validation for Professionals