Innovative Strategies - Harnessing Design Controls for QMS Excellence

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Faculty: José Mora ‎ ‎ ‎ ‎ ‎‎ ‎ ‎ |‎ ‎ ‎ ‎ ‎ ‎ ‎ ‎ ‎ Code: MD1886

  • Date:7/31/2023 11:00 AM - 7/31/2023 12:30 PM
  • Time zone: Eastern Time (US/Canada) Online Event

Description

Creating a Quality Management System (QMS) in the life sciences requires a systematic approach to ensure compliance with regulatory requirements and adherence to best practices.

Given the diverse and broad scope and applications of life science products and services, the creation and application of a QMS can lead to confusion, questions, and many different regulations, standards, and terminology.

WHY YOU SHOULD ATTEND:

Overall, creating a QMS in the life sciences requires a commitment to quality, compliance, and continuous improvement. It involves a collaborative effort across all levels of the organization, from management to frontline staff, to ensure that quality is built into every aspect of the product, service, or process.

The use of design controls is an innovative yet proven method for product and process development, verification, and validation.  This webinar introduces using this proven approach to the creation of a QMS for a life science enterprise.

Given the never-ending volume of information, the lean documents and lean configuration approach provides a single source of truth and streamlined data set to help create and manage a QMS.

AREAS COVERED IN THE SESSION:

  • Introduction to principles of lean documents and lean configuration
  • Defining the scope of the QMS
  • Using design controls to build the QMS and assure it meets requirements:
    • Design & Development Plan
    • Design Input
    • Design Output
    • Design Review
    • Design Verification
    • Design Validation
    • Design Transfer
  • Identifying the risks
  • Development of procedures (SOP, Work Instructions, etc.)
  • Establishment of controls
  • Implementation of the QMS
  • Maintenance and improvement of the QMS
  • Summary
  • Conclusion

WHO SHOULD ATTEND:

  • Quality Assurance Departments
  • Quality Control Departments
  • Regulatory Affairs Departments
  • Research and Development Departments
  • Manufacturing Departments
  • Engineering Departments
  • Operations Departments
  • Production Departments
  • Risk Management Professionals

Course Director: JOSÉ MORA

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, orthopaedic 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 José’’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.