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Join Limor Teomim and Ido Raz as they look at a strategic modernization approach to adapting computer system validation (CSV) to evolving technological landscapes define risks in software validation:
- How technology changes impact software risk management
- How to implement risk-based approach in SaaS
- Regain system ownership with modern software validation
- Digital validation VS paper based validation
- Optional – Risk based KPIs
Takeaways
- Modern SaaS validation process flow
- Lessons learned from implementing digital and automated validation tool – Questions and answers
Ido Raz, CEO, Validify
Bio: Ido Raz is a co-founder and CEO of Validify. Ido has extensive experience in providing solutions
for organizations in the life sciences and other regulated industries. Ido led global technological
and implementation teams, specializing in providing IT compliance and quality applications. He
is an experienced compliance and cGMP professional and a cloud technology enthusiast. Ido
holds a B.Sc. in Industrial Engineering and Management with a major in Information Systems.
Ido founded Validify with two co-founders to bring modern automation capabilities to the
traditional computer software validation process by allowing an on-going approach, focusing on
identification of risks and software changes automatically.
Limor Teomim, CEO, IMP Clinical Supply Services
Bio: Limor has over 25 years of experience in the pharmaceutical and cannabis industries. At the establishment of IMP, Limor joined the team and has been an integral part of the company structure. She has taken a lead part in building the company culture, quality management, and systems. As CEO, Limor is leading the strategic and operational growth of the company to become a significant service provider for clinical studies / medical cannabis sponsors / companies. Limor brings her experience in both manufacturing and development of commercial and Investigational Medicinal Products, quality management systems, cGMP, GDP and local regulations to develop IMP into a top-quality leader in the field. Certified by both the American and Israeli quality societies as a Certified Manager of Quality (CMQ), she has served as a Quality Director of IMP and as VP Quality of Bioforum group. Prior to that, Limor held positions as Quality Manager for LycoRed Bio and Nesher Solutions and as a member of the Quality Assurance team at RAFA. Limor holds an M.Sc. Pharm in Pharmaceutical Chemistry and a B.Sc. in Chemistry from The Hebrew University of Jerusalem, Israel.
Date: 28/12/23 11:00 AM (IL)
Time: 60 minutes
Language: Hebrew