Managing The Audit Function In A Global Company

Audits on their own are simple efforts to identify non-conformances and deficiencies in a process or a system. Independent examination and unique problem-solving skills are essential for identifying and solving complex issues. Employees and functions in this auditing role typically report to executive management. This happens because their recommendations must cross various functional and departmental boundaries.

The audit function for a global company can be an invaluable resource as long as this function has the extensiveness and comprehensiveness of critical thinking skills, experience, and quality systems. Risk-management skills and regulatory know-how to view audits in their appropriate context and offer suitable inputs as part of a comprehensive program of improvement is a must.

Too often, companies default to old habits and procedures which can result in wrong decisions and, sometimes even fatal results.

Why You Should Attend:

This webinar will focus on the role, skills, organizational opportunities, and the benefits of an independent audit group to counsel senior management on the factual causes of complex situations. Although the typical setting would be in larger multi-national companies, this role can be sized to meet the needs of all companies, especially when the situations will cross national, divisional, and organizational boundaries.

The auditing group must be carefully vetted and staffed with the proper combination of experience and critical thinking skills. They must also be able to think and act with a holistic view of the situations they are handling. This is especially essential as this avoids the problem of group-thinking which leads to a proper assessment and better counsel to senior management.

Areas Covered in the Session :

  • Fundamentals of Auditing
  • Auditors and organizations
  • Auditors and reporting relationships in complex companies
  • The mission of corporate departments
  • Goal: independent experts that support effective problem-solving
  • Examples, issues, and outcomes
  • The growing need for corporate problem-solvers

Who Should Attend:

  • Quality Assurance Departments
  • Quality Control Departments
  • Research and Development Departments
  • Regulatory Affairs Departments
  • Manufacturing Departments
  • Engineering Departments
  • Operations Departments
  • Production Departments
  • Compliance Departments
  • Documentation Departments
  • Design Assurance Teams
  • HR Staff
  • Everyone with audit responsibilities

FDB3047

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.

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  • Login Information with Password to join the session, 24 hours prior to the webinar
  • Presentation Handout in .pdf format
  • Presentation from the Speaker
  • Feedback form
  • Certificate of Attendance
  • Recording access Information with Password to view the webinar, will be sent 24 hours after the completion of the Live webinar.
  • Presentation Handout in .pdf format
  • Certificate of Attendance
.