Course Description - Course runs 9:00 - 5:00 on Day 1 & Day 2 -- 9:00 - 3:00 on Day 3 (Breakfast & Lunch Included)

Participants will learn how an effective Process Validation system is a critical requirement to the movement toward a risk-based approach to compliance and product safety. Also to be discussed is how to tackle process validation for medical device combination products.

Issues to be covered include:

• Learn how poor validation procedures and practices can lead to regulatory actions from regulators
• Assurance of product quality derived from a compliant validation program
• Learn how to improve process system knowledge and understanding
• Learn methods for developing process validations and best practices
• Understand the scope of regulations governing process validation and identify gaps
• Develop a plan to rectify existing validation plans, protocols and reports
• Learn how to implement and deploy a master validation plan

Attendees are encouraged to bring examples of Process Validation issues/concerns that they would like to reviewed and discussed during the course.

Why This Course Matters

The guideline on "General Principals of Process Validation" was issued in May, 1987, and since then, medical device companies have struggled with the principals of process validation. Internationally, regulators believe through careful design and validation of the process and appropriate process controls, a manufacturer can establish a "high degree of assurance" that all manufactured units from successive lots will be acceptable. Successfully validating a process may reduce the dependence upon intensive in-process and finished product testing. More recently, with the introduction of risk management to medical devices, it is important to correctly apply the principles of risk management when implementing and maintaining process validation activities.

Newer products and processes pose additional challenges to organizations. New processes are more complex thereby making process validation more difficult. Using the tools developed in this course, participants will be able to methodically plan and conduct a process validation.

Who Should Attend

This three-day medical device validation training is targeted toward Medical Device professionals directly involved in meeting International and FDA's Quality System requirements specifically relating to Process Validation.

Typical attendees include: Professionals in Regulatory Affairs, Quality Assurance & Control, Auditing & Compliance Engineering, Process Development, Quality Engineering, Manufacturing Engineering, Design & Development Engineering, Documentation Control Specialists.

To maximize the peer learning opportunity, this course is recommended for those who may have a core level of understanding of Medical Devices, the Quality System Regulation (QSR) and/or ISO 13485, with some direct work experience.

This course provides attendees with the knowledge and skills needed to comply with the process validation requirements of the FDA's Quality System Regulation (CFR 820), and the Quality System standard ISO 13485 while providing direction on how to implement an effective process validation program.

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:

• Integration of Risk Management Principles and Activities into the Quality System
• Medical Devices: Developing Effective Post Market Surveillance and Complaint Handling Systems
• Medical Devices: EU Directives, Guidance, CE Marking and ISO Standard Certifications