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Inspection, Measuring and Test Equipment: A Regulatory Approach
The journey toward medical device acceptance is long and rigorous, requiring vigilance around device quality, monitoring of external partners and readiness for regulatory audits.
One crucial step in this process? A control system with an effective inspection, measuring and test equipment (IM&TE) assessment program.
Has your team created the best system for assessing the technical and regulatory compliance of its products? Have you developed avenues to maintain quality through the processes of external suppliers? Are you prepared for the external audits your device will face before being accepted?
Ensuring your product has met all the requirements necessary to gain approval is demanding, but it doesn’t need to be painful.
This FDAnews webinar can help make your sustained efforts toward approval simpler, more transparent and most importantly, successful. Along with straightforward advice on managing what can easily turn into an unmanageable process, you’ll receive an internal audit checklist, a sample of a quality agreement and a traceability diagram template.
Operations management expert Dan O’Leary will share how to meet both the technical and regulatory requirements around inspection, measuring and test equipment. He will discuss creating a combined Quality Management System (QMS) — covering practical information on traceability diagrams, precision and accuracy testing, creating internal audit mechanisms for outsourced processes and preparing for external regulatory audits.
Key Webinar Takeaways:
- Technical Aspects of Inspection, Measuring and Testing Equipment
- Definitions and examples of accuracy, precision and traceability
- Regulator Requirements and Audits
- The requirements of FDA QSR and ISO 12485:2016
- Expectations around the Quality System Inspection Technique (QSIT) and Medical Device Single Audit Program (MDSAP) audit model
- Examples of manufacturer issues through FDA warning letters
- Quality Management Systems
- Merging and covering technical and regulatory requirements
- Necessary elements of a combined QMS system
- The effective use of quality audits and international quality audit programming
- Metrology Chains
- Identifying, evaluating, selecting, controlling, evaluating and managing suppliers through a QMS
- Quality agreements covering outsourced processes
- Preparing traceability diagrams to ensure internal controls
Between sample documents, expert tips, and detailed explanations of inspection, measuring and test equipment assessments, this webinar will have you well prepared to meet any and all approval requirements. Join us by registering today.
Meet Your Presenter:
Dan O’Leary, president of Ombu Enterprises, LLC, has more than 30 years of experience in quality, operations, and program management in regulated industries, including aviation, defense, medical devices and clinical labs. Ombu Enterprises offers training and execution in operational excellence, focusing on analytic skills and a systems approach to operations management. O’Leary has a masters degree in mathematics and is an ASQ-certified biomedical auditor, quality editor, quality engineer and reliability engineer. He is also certified by APICS in resource management and is a Six Sigma Black Belt.
Who Will Benefit:
- Medical device manufacturing teams
- Quality managers and engineers
- Production managers, supervisors and engineers
- Manufacturing engineers
- Purchasing managers and agents