Process Validation Course for the Medical Device Industry
Sep 4, 2024
By Jose (Yossi) Chvaicer, M.Sc. & Haim Eliyahu, M.Sc.
מחזור 7
Engineering & Validation
Starts at: 09:00
Duration: 4 Meetings
Language: Hebrew
The aim of this course is to teach Process Validation for Medical Devices.
This content-rich course emphasizes providing participants with methods that will enable them to cope with the Validation challenges in the Medical Device industry under the requirements from ISO13485:2016 and 21CFR820. Special processes, Validation principles, and hands-on techniques will be discussed, including Risk Assessment, Master Validation Plans, Installation, and Operational and Performance qualifications.
Examples of worst-case conditions and case studies will be extensively explored, including Sample size selection, Process Capability, and how to maintain the validation state.
Course dates:
04.09.2024
11.09.2024
18.09.2024
25.09.2024
Hours: 09:00-16:00
Location - Building 22 Matam Park, Haifa
Price - 4,800 NIS + VAT
About Jose (Yossi) Chvaicer, M.Sc.
Mr. Jose Chvaicer graduated in Mechanical Engineering from the State University of Rio de Janeiro, Brazil, and he has a Master’s Degree in Industrial and Management Eng. from the Technion – Israel Institute of Technology, Haifa, Israel. Jose holds a lead auditor certificate from the IIS (ISO9001, ISO13458).He has over 25 years of international experience in the Pharmaceutical Industry. While...About Haim Eliyahu, M.Sc.
Haim holds a B.Sc from Tel Aviv University and an M.Sc in Molecular Genetics. Haim has extensive experience in leading, promoting and executing process validation (PV) projects, validation of testing methods (TMV), computerized systems validation (CSV), validation of systems, clean rooms and pharma equipment. Leading and executing risk management (pFMEA) and team leadership.In his previous role at RS NESS, he...
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The aim of this course is to teach Process Validation for Medical Devices.
This content-rich course emphasizes providing participants with methods that will enable them to cope with the Validation challenges in the Medical Device industry under the requirements from ISO13485:2016 and 21CFR820. Special processes, Validation principles, and hands-on techniques will be discussed, including Risk Assessment, Master Validation Plans, Installation, and Operational and Performance qualifications.
Examples of worst-case conditions and case studies will be extensively explored, including Sample size selection, Process Capability, and how to maintain the validation state.