Through the Eyes of an Auditor

Internal and external audits are an integral part of running a medical device or biotechnology manufacturing operation. To be sure, auditors must follow standards such as ISO 13485, ISO 14971, or regulations such as 21 CFR Part 820. Additionally, an auditor has personal experiences of what a state of control looks like and has visited sufficient places to know what to look for.

Anyone in a medical device setting must be prepared for an audit at any and all times. This webinar provides insight into the kinds of clues an auditor might use in determining what areas to focus on. It isn’t intended to cover all regulations and standards. What it does cover is the general mental checklist that will influence how well an audit goes, as well as the culture and environment a company’s management must encourage so that impression is a good to excellent one.

Why You Should Attend:

An experienced auditor does not need to dig very far – he or she already has a mental checklist. You need to know what that is. Their first impression may have a major impact on your plant’s future as well as your own career.
– How will your plant look to that auditor?
– Before they even set foot in the door – what your grounds and outside facility says about your operation?
– Approaching the production area – tell-tale signs that will influence the auditor’s perception.
– Your cleanroom gowning area – how the audit could be almost over before it has even started?
– It’s only a utility room – why would they want to look in there?
– Your janitor’s closet – it might as well be your front porch.
– Do you follow your own rules? The auditor is noticing this very carefully – and taking notes.
– Can you “put your hands on it.” Documents, procedures, manuals, and reports – why five minutes may be too long to change a first impression.
– Process and environmental control – quick impressions.
– The importance of visual indicators – and following them.
– How auditors can help you be in a state of constant readiness.

Areas Covered in the Session :

  • What the auditor is looking for and why
  • The first five minutes
  • Touring the plant and manufacturing area
  • Entering and touring the warehouse
  • Entering and touring a cleanroom
  • Entering and touring lab areas
  • Reviewing documents
  • Reviewing the quality system
  • Summary
Who Should Attend:

  • Research and Development Departments
  • Quality Departments
  • Manufacturing Departments
  • Engineering Departments
  • Operations Departments
  • Design Assurance Teams
  • Document Control Professionals

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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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  • Presentation Handout in .pdf format
  • Certificate of Attendance