Current Good Manufacturing Practices
  • CODE : JOMO-0066
  • Duration : 60 Minutes
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José 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. José 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, orthopedic implants and instruments, and vascular surgery grafts and textiles. During his time at Cordis, José 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.

Current Good Manufacturing Practices, which include current good documentation practices, and elements of continuous improvement are both a law (regulations) and the right thing to do for any manufacturing operations.

During this webinar, we will focus on 15, basic-to-intermediate, practices, including what they mean, how they work together, and why they stimulate continuous improvement (and yes, they do not stiffen innovation).

While each of the practices can be implemented and benefited from by itself, the most benefit comes from understanding them all and working through implementing and practicing them all.

Areas Covered

  • Introductions
  • Introduce the cGM/Ds Practices (15)
  • Talk about each practice and what value it brings (standalone)
  • Questions and answers
  • Resources (and ask)

Who Should Attend

  • Quality engineering
  • Quality specialist
  • Quality Managers
  • Quality Directors
  • Quality Inspectors
  • Manufaturing engineers
  • Manufacturing supervisors
  • Oeprations excellence leaders
  • Operations excellence engineers
  • Operations excellence managers

Why Should You Attend

Current Good Manufacturing/Documentation Practices are not optional. They are a law that all regulated industries and by extension, all manufacturing companies in those industries must adhere to. Otherwise, huge financial and reputational penalties and consequences can be experienced.

Furthermore, cGM/DPs are a necessary basis for companies that must, should, and want to drive continuous improvement in order to drive costs down and efficiency up.

Topic Background

Any (manufacturing) organization, especially if part of the regulated industry (medical device/life sciences, automotive, airspace) is subject to good manufacturing (and documentation) practices. Other manufacturing organizations can benefit greatly by following the same practices, as they are all grounded in best practices and continuous improvement.

  • $200.00



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