Webinar: Unveiling the Secrets of Successful Process Validation
Monday | 03.06.2024 | 14:00
Join us for a Deep Dive into Process Validation: Regulations & Real-World Applications
Flex, is a global manufacturing and supply chain solutions company that provides design, engineering, and manufacturing services across a variety of industries including, communications, consumer devices, healthcare, and industrial sectors, is heavily involved in the medical device industry. Flex offer a wide range of medical products and services, leveraging their advanced manufacturing capabilities and extensive supply chain to produce high-quality medical devices
Gsap by Novolog is an international consulting firm for healthcare companies, providing end to end services throughout the life cycle of medical products.
Gsap aspires to enhance the development and maturation of healthcare companies and to empower them to achieve significant therapeutic solutions for patients worldwide.
WEBINAR'S PRIMARY TOPICS
Introduction
5 Steps for successful Process Validation
PV from Flex's POV: Do It Right the First Time
Hit the expert - The questions you never dare to ask
What will you gain?
Process validation in the medical device industry plays a crucial role in ensuring a successful and effective manufacturing flow.
The various challenges associated with process validation can be demanding and often require innovative, out-of-the-box solutions.
Gsap, in collaboration with Flex, has joined forces to address the most common challenges in the process validation (PV) process. In order to contribute to the successful completion of PV, we hope to impart to our community our vast professional knowledge and practical expertise.
Speakers
Elias Morany, M.Sc. Engineering and Validation Section Manager- Gsap
Elias Morany has a Bachelor’s degree (B.Sc.) from the Faculty of Biotechnology and Food Engineering at the Technion – Israel Institute of Technology, and of a Master’s degree (MSc) in System Engineering.
Elias has wide knowledge of production processes and experience in leading, promoting and conducting cross-organizational engineering projects, validation and technical characterization of systems, equipment and utilities, manufacturing plants design and leading teams.
At his former position in Protalix, he led validation projects of critical utilities and equipment, and in Florish he led improvement and optimization processes of new and existing products.
At Gsap, Elias manages the Engineering and Validation section, leads large projects: founding clean rooms and laboratories, GMP consultation at planning stages and execution through to overall validation of the setting.
At Gsap Elias led Projects for the following companies: Pluristem, Accellta, BI Industries, Brainstorm, SME, Equashield, Foamix, Kadimastem, Intec Pharma, Tamar Marketing, Maayan-Haim, Perrigo, Curetech, Cellcure, Phibro, Amorphical, Taro, Medimor, Syqe and Efranat.
Vered Birnbaum Keren, Director of Quality, Flex
Vered Birnbaum-Keren serves as the Director of Quality at Flex, With over 18 years of hands-on experience in quality assurance and compliance, Vered is a seasoned expert in ensuring the highest standards of quality, particularly in the production of medical devices.
In her role at Flex, Vered oversees all aspects of quality assurance and regulatory compliance, driving the company's commitment to excellence in medical device production. Her expertise and practical knowledge contribute significantly to Flex's ability to deliver reliable and innovative solutions across various industries.
Jose (Yossi) Chvaicer, M.Sc. Senior Validation and Quality Project Manager
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 being an expert in Validation of equipment and utilities (DQ/IQ/OQ/PQ) he has a rich background managing large scale engineering projects in cGMP environments including design, building and commissioning of production plants, manufacturing and packaging lines, analytical laboratories and warehouses. Yossi is also an expert in leading certification projects on pre-inspections for utilities and equipment for manufacturing finish products (API’s, OSD and Biotech plants) including Autoclaves, Purified Water and HVAC systems. He has conducted FAT’s worldwide and has created and applied an innovative model for Design Qualification (DQ) which reduces costs while meeting quality requirements. More recently, Yossi has managed Compliance and Validation complex projects in the Medical Device industry. Yossi, a Six Sigma Green Belt, brings extensive experience in quality audits (Israeli MoH, FDA and EMA) and in leading multidisciplinary improvement teams for production processes and organization support for Process Validation. He is highly motivated for team work and for leading quality and engineering projects.
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Unveiling the Secrets of Successful Process Validation Webinar
For more information or questions,
contact us - Gstudy@gsap.co.il
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