Medical Devices Quality System Requirements Course
Sep 2, 2024
By Dana Tirosh B.A.
Cycle 12.0
Quality
Regulatory
Starts at: 09:30
Duration: 2 Meetings
Language: Hebrew
This course will review the fundamentals of how to establish a Culture of Quality and build a Quality System According to ISO 134852016 and 21CFR820, including Document and Record controls (DHF, DMR, DHR, QMS records), Management responsibility, Resource management, Quality review, Purchasing
controls, Evaluation, and selection of suppliers, Acceptance sampling inspection principles, Design control, Production & service control, and Measuring equipment control.
Including Principles for statistical sampling selection.
Course dates:
02.09.2024
09.09.2024
Course Hour's - 09:30-15:30
Location - Building 22 Matam Park, Haifa
Price - 3,000 NIS + VAT
About Dana Tirosh B.A.
Regulatory and Quality expert and a certified lead auditor (BSI Certified Lead Auditor - ISO 13485:2016 IRCA Certified) Experienced in establishing, implementing and maintaining a QMS, well familiar with international standards and regulations, audit management, project oversight and Global Regulatory Submissions. Successfully participated in many ISO 13485, EU and MDSAP Audits as the lead point of contact. Dana is...
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This course will review the fundamentals of how to establish a Culture of Quality and build a Quality System According to ISO 134852016 and 21CFR820, including Document and Record controls (DHF, DMR, DHR, QMS records), Management responsibility, Resource management, Quality review, Purchasing
controls, Evaluation, and selection of suppliers, Acceptance sampling inspection principles, Design control, Production & service control, and Measuring equipment control.
Including Principles for statistical sampling selection.