Process Validation Requirements & Compliance Strategies

This webinar will review process validation basics with an emphasis on looking beyond compliance towards achieving a robust process. Process Validation will help you analyze and provide in-depth knowledge of what you need to know about scrutinizing medical devices and other types of surgical instruments. You will also be briefed about various FDA laws that govern their usage and eliminate common human errors while operating these devices. Apart from this, you will learn how you can increase the scope of your reliability and get friendly using these onerous devices.

• To learn the importance of Process Validation
• To learn the basic steps involved
• Impacts of Process Validation in the medical industry
• Effect of Process Validation in compliance with the FDA
• How Process Validation increases reliability?
• Whether any risk is involved in Process Validation
• How you can minimize the common errors?
• How you can enhance the quality of your design?

• Global Harmonization Task Force requirements (includes FDA and ISO)
• Installation Qualification (IQ)
• Operational Qualification (OQ)
• Performance Qualification (PQ)
• Design Qualification
• Facilities and utilities
• Strategies for achieving a robust and reliable process
• Typical process validation protocols

When used as intended, process validation can provide increased process reliability, improved yields, and reduced operating expenses.

• Research and Development departments
• Engineering departments
• Quality departments
• Manufacturing departments
• Operations departments
• Production departments
• Document control professionals
• Device development teams
• Quality Auditors
• Personnel involved in Verification and Validation planning, execution and documentation for devices

Jose Mora is a Principal Consultant specializing in Manufacturing Engineering and Quality Systems. For over 30 years he has worked in the medical device and life sciences industry specializing in manufacturing, process development, tooling, and quality systems. Prior to working full time as a consulting partner for Atzari Consulting, José served as Director of Manufacturing Engineering at Boston Scientific and as Quality Systems Manager at Stryker Orthopedics, where he introduced process performance, problem solving, and quality system methodologies.

During that time he prepared a white paper on the application of lean manufacturing methods to the creation and management of controlled documents and a template for strategic deployment. Jose led the launch of manufacturing at a start-up urology products company as Director of Manufacturing for UroSurge, Inc. at the University of Iowa's business incubator park in Coralville, IA, creating a world-class medical device manufacturing operation, with JIT, kanban systems, visual workplace and lean manufacturing practices. José worked for 10 years at Cordis Corporation, now a Cardinal Health company, where he led the successful tooling, process development and qualification of Cordis' first PTA (percutaneous transluminal angioplasty) catheter. His medical device experience includes surgical instruments, PTA & PTCA dilatation and guiding catheters, plastic surgery implants and tissue expanders, urology implants and devices for the treatment of incontinence, delivery systems for brachytherapy, orthopaedic implants and instruments, and vascular surgery grafts and textiles.

During his time at Cordis, Jose managed the Maintenance and Facilities Department, taking that operation to a level rated as "tops" by the UK Department of Health and Social Services (DHSS) during one of their intensive audits. Jose managed Manufacturing Engineering as part of the Guiding Catheter Core Team of managers, a team that took the Cordis Guiding Catheter business to lead the market, bringing it up from fourth place. By introducing world-class techniques, the Guiding Catheter design and manufacturing was completely re-engineered for robust design and tooling, under Jose's leadership. He was also instrumental and played a leadership role in the complete re-engineering of the Tooling Control System, including design drafting, the tool shop and technical support. Wherever he has worked, he has a track record of introducing world-class methodologies such as Kepner-Tregoe, Taguchi techniques, Theory of Constraints, Lean Manufacturing, Five S (Visual Workplace), process validation to Global Harmonization Task Force standards, and similar approaches