Process Validation
Nov 7, 2022
By Haim Eliyahu, M.Sc. & Jose (Yossi) Chvaicer, M.Sc.
2.0
Quality
Regulatory
Engineering & Validation
Starts at: 09:00
Duration: 4 Full Days
Language: Hebrew
The aim of this 4-day course is to learn process validation for medical devices. The emphasis of this content-rich course is to provide the participants with those methods which will enable them to cope with the validation challenges in the medical device industry under the regulatory requirements from the 21CFR 820 FDA and ISO 13485. Special processes, validation principles, and hands-on techniques will be discussed including risk assessment, master validation plans, installation, 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 state of validation.
Course dates:
07/11/22
14/11/22
21/11/22
28/11/22
Course Location: Matam Park, Haifa
Fee: 4,000 NIS + VAT
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...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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Comments
The Course will take place at 4 meetings:
07/11/22
14/11/22
21/11/22
28/11/22
Fee: 4,000 NIS + VAT
For more details and course costs sign up and we will get back to you with all the relevant information.
**The course will be held according to the procedures of the Ministry of Health during the Corona period, in a large space that allows for social distance and observance of the rules
For further information please contact Lital at Lital@gsap.co.il