Applying Risk-based Approaches to Processes Under the Quality Management System
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Speaker : DON HURD
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When : Thursday, September 26, 2024
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Time : 01 : 00 PM EST
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Don Hurd has over 40 years of experience in supporting the development of applications of or containing software in regulated industries, the last 20 in medical devices.
- Established company QMS and led company to 13485 registration (12+ years); dual registration to 9001 (8+ years)
- Successfully led numerous companies through standing up a new QMS, leading to ISO 13485 certification
Serving as ‘Quality Manager’ and ‘Management Representative’ for several companies
Just about every process in the QMS can be driven through risk-based thinking. Creating a simple and effective plan is key to a successful application. This discussion will outline specific proven approaches to specific processes, ensuring both a rigorous approach and one that is acceptable to auditors/inspectors.
Areas Covered
- The “big” ones: purchasing, training, computer system validation
- Others: Audits, Management Review, Infrastructure, Calibration
- Even more: Work Environment, Contamination Control, Traceability
- Probably already doing: complaints, CAPA, postmarket
Who Should Attend
- Management
- Project Managers
- Quality Engineers
- Purchasing
- Postmarket support
Why Should You Attend
Regulatory bodies expect manufacturers to take a risk-based approach with processes required by regulations & standards. Manufactures and specification developers often have a difficult time with this concept. They are often taking risk-based approaches, but struggle when trying to institutionalize the approaches.
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$160.00
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