Conducting Effective Internal Quality Audits - Webinar CD/Transcript

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Conducting Effective Internal Quality Audits: Device Guru Shares 25 Years of Experience

It’s estimated that 75% of device manufacturers conduct internal audits solely “because we have to – because the FDA and ISO regs say so.”  This attitude results in poorly trained internal auditors, ineffective audits and typically FDA 483s and warning letters when a company faces an inspection.

Currently many device companies employ the “part-time” auditor approach.  Or, worse than that, management conducts the audits and writes the reports.  These common approaches doom companies to failure.

This crash course will teach you how to build and implement a highly effective, independent internal audit program including:

  • Why audits are needed and how can companies better use audits?  How the “we have to” mentality leads to QSR violations, recalls and poor company performance.
  • Making audits work – how to structure an audit program and score it to assure its effective. 
  • Who should be your auditor?  Hint:  Not everyone can be a good auditor — good auditors have these seven characteristics.
  • Proven methods to create a risk-based audit schedule and determine audit frequency. Attendees will be provided a comprehensive audit frequency criteria template.
  • Best practices for writing good audit reports and communicating them with the team and management.
  • How to document and report nonconformances.  An example report format that has been successful used by numerous companies will be provided to attendees.
  • Selling effective quality audits to management.  Independently managed auditing has the added benefit of identifying redundancies in systems resulting in obvious cost and time savings
  • Understanding 12 common mistakes — that commonly found their way into Form 483s — that can be eliminated with effective internal auditing.
  • Medical device manufacturing and executives
  • Auditing and compliance officers
  • QA/QC managers and directors
  • Production managers
  • Production supervisors
  • Process development staff
  • Auditing and compliance officers
  • Training managers
  • Regulatory affairs professionals
  • Executive management
  • General/corporate counsel
  • Personnel new to the industry

Susan Reilly, Reilly Associates LLC — Susan Reilly has more than 25 years of quality system, quality engineering, and regulatory compliance experience in the medical device area. Her company provides practical and cost-effective quality and regulatory consulting services to ensure conformance with FDA regulations, EU requirements, Canadian requirements, and ISO Standards. Prior to becoming an independent consultant in 1999, she was Director, Quality Systems, at Medical Device Consultants, Inc. (MDCI) and Manager, Quality Assurance at Deknatel Division, Pfizer Hospital Products Group, Inc. She was also a Quality Engineer at Burron Medical Inc. Ms. Reilly has served as an expert witness on behalf of the Food and Drug Administration and was an active participant in the FDA/Medical Device Industry Initiative Task Force. She is a member of the Advisory Committee for the ASQ Certified Quality Auditor - Biomedical Certification and a past member of the AdvaMed (formerly HIMA) QA Committee. Ms. Reilly is a contributing author to "The Biomedical Quality Auditor Handbook" (ASQ) and the original technical editor for "The Quality System Compendium - GMP Requirements and Industry Practice" (AAMI).