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...About Hadar Shoham, B.Sc.
Hadar Shoham is a Validation and Engineering Project Manager at Gsap. She holds a B.Sc. degree in Chemical Engineering from the Technion, and has 12 years' experience in global facilities in Israel and in the US. Hadar has proven skills in designing and implementing manufacturing processes and utilities on scales ranging from lab to developmental pilot plant to full commercial...
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Comments
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.