Process Validation Course for the Medical Device Industry
Engineering & Validation
Starts at: 09:00
Duration: 3 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:
11.03.2025
18.03.2025
23.03.2025
Hours: 09:00-16:00
Location - Building 22 Matam Park, Haifa
Price - 4,500 NIS + VAT-Early bird registration is now open!
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...
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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.