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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:
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).
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